Status: RECRUITING

Background

Lymphangioleiomyomatosis (LAM) is an ongoing lung disease causing cysts that affects 30-40% of women with tuberous sclerosis complex (TSC), and about 4-7 women per million in the population at large who do not inherit a genetic disease. Patients with LAM lose the use of their lungs rather quickly.

The average age for diagnosis of LAM is 35 years. Within 10 years of a women having her first symptom, 55% of patients are breathless when walking on flat ground, 20% require supplemental oxygen and 10% are deceased. Recent data suggests the average survival time once symptoms begin to be 15-30 years.

Studies of patients with non-inherited LAM and of those patients who are re-diagnosed with LAM after lung transplant have shown uncontrolled growth of muscle cells in the lungs. A relationship between LAM and the tuberous sclerosis genes have been found. These genes cause irregular cell growth and release of lymphangiogenic growth hormone into the body.

A previous study (MILES) showed an increase in lung function for those patients who were taking sirolimus. Lung function was determined by pulmonary function testing, which measures how well a person moves air into and out of their lungs. When sirolimus was ended, patients' lung function began to deteriorate again. The MILES study showed that sirolimus stabilized lung function and improved quality of life for LAM patients.

The research questions are:

1. What are the demographic and clinical details of LAM patients treated with long-term sirolimus or everolimus?
2. What safety concerns are there when LAM patients take sirolimus or everolimus long-term? What symptoms do LAM patients who take sirolimus or everolimus have while taking the drug long-term? How often and why do LAM patients stop taking sirolimus or everolimus? How often are LAM patients taking sirolimus or everolimus hospitalized or receive lung transplants? What is the rate of death of LAM patients taking siroliums or everolimus?
3. How does lung function compare in LAM patients who take sirolimus or everolimus long-term versus those who do not take either medication?

About this Study

The purpose of this study is to create a registry database of patients diagnosed with LAM who are taking or planning to take sirolimus or everolimus. From this database researchers will be able to collect and analyze data to determine if long-term sirolimus or everolimus use is helpful and safe for LAM patients.

There will be a total of 300 participants with LAM in this study.

Subjects that agree to be in the study will be asked to participate in the following:

• Review, ask questions about and sign an informed consent
• Attend at least one annual visit to an RLD clinic
• Perform all standard testing during their visit(s) to the RLD clinic
• Follow treatment instructions from the clinician at their RLD clinic

Targeted Enrollment

To be eligible to participate, you must be:

• Female, age 18 or over
• Diagnosed with LAM
• Currently taking sirolimus or everolimus, previously having failed or been intolerant of sirolimus or everolimus, newly treated with sirolimus or everolimus, or considering therapy with sirolimus or everolimus

You are not eligible to participate if:

• You are unable to attend at least one RLD clinic visit per year
• You are not able to provide informed consent for participation
• You are not able or willing to perform lung function testing

How to participate:

We greatly appreciate your interest in this study and in helping us understand the long-term treatment of LAM with sirolimus or everolimus.

In order to participate, you must personally contact the study coordinator of any of the participating institutions by phone or by email. Please use the information below to inquire about participation:

California

Susan Jacobs, RN, MS
Nurse Coordinator
Stanford University Medical Center
Phone: 650-725-8083
E-mail: ssjpulm@stanford.edu

Florida

Shannon Kennedy, CCRP
Lead Certified Clinical Research Coordinator
Mayo Clinic - Jacksonville
Phone: 904-953-7439
E-mail: Kennedy.Shannon@mayo.edu

Massachusetts

Shefali Bagwe, MBBS
Clinical Research Coordinator
Brigham and Women's Hospital - Harvard Medical School
Phone: 857-307-0784
E-mail: sbagwe@bwh.Harvard.edu

Michigan

Catherine Meldrum, PhD, RN, MS, CCRC
Study Coordinator
Univeristy of Michigan
Phone: 734-647-7840
E-mail: cathymel@umich.edu

Missouri

Hannah Perkins
Study Coordinator
Washington University School of Medicine
Phone: 314-362-9919
E-mail: hperkins@wustl.edu

New York

Elizabeth Lyda
Study Coordinator
University of Rochester Medical Center
Phone: 585-233-4358
E-mail: elizabeth_lyda@urmc.rochester.edu

Ohio

Joanne Baran, RN
Study Coordinator
Cleveland Clinic Foundation
Phone: 216-444-5023
E-mail: baranj2@ccf.org

Tammy Roads, CCRC
Research Associate, Clinical Trials Manager
University of Cincinnati
Phone: 513-558-2148
E-mail: roadst@ucmail.uc.edu

Oregon

Samantha Ruimy, MS
Study Coordinator
Oregon Health & Science University
Phone: 503-494-0724
E-mail: ruimy@ohsu.edu

Pennsylvania

Carly D’Errico
Study Coordinator
University of Pennsylvania Medical Center
Phone: 215-746-4219
E-mail: derricoc@mail.med.upenn.edu

Tennessee

Errine Garnett
Study Coordinator
Vanderbilt University Medical Center
Phone: 615-343-0539
E-mail: Errine.T.Garnett@vanderbilt.edu

Texas

Tiffany Ostovar-Kermani, MD, MPH
Study Coordinator
The University of Texas Health Science Center at Houston
Phone: 713-500-6851  
E-mail: Tiffany.G.OstovarKermani@uth.tmc.edu 

Adetoun Sodimu, MPH, CPH
Clinical Research Manager
University of Texas Souhtwestern Medical Center
Phone: 214-645-6493  
E-mail: Adetoun.Sodimu@utsouthwestern.edu

Utah

Silvia Smith, Ph.D
Study Coordinator
University of Utah School of Medicine
Phone: 801-581-5811
E-mail: Silvia.smith@hsc.utah.edu

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Status: RECRUITING

Study Summary

Please Note: The Rare Diseases Clinical Research Network will make every effort to enroll all the patients we can, but we cannot make any guarantees that we will be able to enroll everyone in a particular study who wants to participate.

Background

Individuals with some types of Hermansky-Pudlak Syndrome (HPS) can develop breathing problems and scarring in the lung (called pulmonary fibrosis). The purpose of this study is to learn more about how people with HPS get pulmonary fibrosis over time, in order to find the earliest signs of lung disease. This study is a longitudinal study which is a research study in which the same subjects are watched repeatedly over a period of time (years). In this study, we will look at symptoms, pulmonary function tests, blood and urine tests, and chest CT scans in individuals with HPS.

The research questions are:

1. What is the first sign of lung disease for people who are at risk for HPS pulmonary fibrosis? When do changes in pulmonary function tests and chest CT scans occur?
2. What are the relationships between certain biomarkers (characteristics of the body) and how the disease develops and how severe the disease is?
3. Is HPS pulmonary fibrosis similar to other causes of pulmonary fibrosis?

About this Study

This is a longitudinal study of up to 150 individuals with Hermansky-Pudlak Syndrome. Those participating in this study will complete questionnaires (surveys) every 12 months. Some individuals will take pulmonary function tests (PFTs), blood and urine tests, and/or chest CT scans every 2-3 years, depending on their age and type of HPS. PFTs and chest CT scans will take place at one of the Rare Lung Disease Consortium clinical sites (locations) (see the list of participating sites below). Questionnaires can be completed by mail, using the computer, or by other communication. Blood and urine tests can be done by the participant’s local doctor.

For each visit, you will be asked to:

• Complete questionnaires about any medical symptoms
• Give blood (2 to 3 tablespoons)
• Give a urine sample (some visits)

Depending on your age and type of HPS, you may be asked to do the following tests every 2-3 years (2 times total):

• pulmonary function testing (PFT)
• a chest CT scan (adults only)

We will look at your medical records from your doctor’s office so that we can get information about your medical history.

Targeted Enrollment

To be eligible to participate, you must:

• Be an individual with the diagnosis of HPS
• Be between the ages of 12 and 90 years

You are not eligible to participate if:

• You have had a lung transplant

How to participate:

In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to inquire about participation.

New York

Columbia University Medical Center, New York
Amika McBurnie
212-342-1518
Akm2192@cumc.columbia.edu

Tennessee

Vanderbilt University, Nashville
Lisa Young, MD
615-343-0539

*Participating clinical sites will be added as each site is activated for a specific protocol

Status: RECRUITING

Study Summary

Please Note: The Rare Diseases Clinical Research Network will make every effort to enroll all the patients we can, but we cannot make any guarantees that we will be able to enroll everyone in a particular study who wants to participate.

Background

The PURPOSE of this study is assemble a group of people with pulmonary alveolar proteinosis (PAP) large enough to accelerate research to improve our understanding, diagnosis, and treatment of PAP.

The REASON for doing the study is that medical progress for PAP is hampered by how infrequently it occurs. About 2000 – 3000 people in the United States have PAP and most doctors have either never seen anyone with PAP or only a few cases in their lifetime. Collecting medical information from many people with PAP in a registry will provide enough information to overcome this barrier to advancement.

Some USEFUL FACTS about PAP include:

• PAP is a condition that can occur in many different diseases – PAP is not one specific disease.
• No tests are available for routine use by doctors to diagnose diseases that cause PAP.
• New tests have been developed but, currently, can only be used in research studies.
• To make these new tests available for clinical use, they must first be evaluated in a research study.
• New treatments for some diseases causing PAP are being developed. However, it will be important to know what disease is causing PAP before any such treatment could be used.

Some QUESTIONS this study will address are:

1. How reliable is the new ‘blood droplet’ test for diagnosis of PAP?
2. How common are the various diseases that cause PAP?
3. What other diseases cause PAP?
4. Are there better biomarkers (potential diagnostic tests) for diseases that cause PAP?

About this Study

This is a cross-sectional study of individuals with Pulmonary Alveolar Proteinosis (PAP) to create the National PAP Registry. A cross-sectional study involves collecting data from PAP patients at one specific time point. We plan to enroll 500 individuals over a 5 year period. Participants will be asked to answer questions about their health and provide a blood sample. We will test your blood and give you the results. With your permission, we will also give the results to your doctor. You will not receive any drug or treatment. The testing is free of charge because the National Institutes of Health (NIH) is providing money for this study. We will look at your medical records from your local doctor’s office so that we can collect information about your medical history. Educational information may be included on the Rare Diseases Clinical Research Network Rare Lung Diseases Consortium website and the PAP Foundation website. Information may include, but is not limited to, updates on PAP research, updates on upcoming studies, progress of current trials, and PAP related events, such as education days and patient/doctor meetings. Further, PAP patients may choose to have their contact information shared with the PAP Foundation. The PAP Foundation may provide patients and their families with newsletters and updates about PAP. These newsletters and updates may include, but are not limited to, updates on PAP research, updates on upcoming trials, progress of current trials, and PAP related events, such as education days and patient/doctor meetings.

Targeted Enrollment

You are eligible to participate, if:

• You are interested in participating in the study and able to provide written informed consent.
• You have been diagnosed with PAP by a doctor. The diagnosis could have be made by several methods including EITHER a chest x-ray, chest CT scan, lung biopsy, bronchoscopic lung lavage (washing), or genetic testing.

You are not eligible to participate if:

• You do not have a diagnosis of PAP

How to participate:

In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to inquire about participation.

Cincinnati Children’s Hospital Medical Center
Contact Name: Brenna Carey
Phone: (513) 636-8916
Toll Free Phone Number: (844) 843-8772 (Administrative assistant, Bettie Durant)
E-mail: Brenna.Carey@cchmc.org

*Participating clinical sites will be added as each site is activated for a specific protocol

Status: RECRUITING

Study Summary

Please Note: The Rare Diseases Clinical Research Network will make every effort to enroll all the patients we can, but we cannot make any guarantees that we will be able to enroll everyone in a particular study who wants to participate.

Background

The PURPOSE of this study is to learn if inhaled sargramostim (Leukine®) is safe for the treatment of the lung disease autoimmune pulmonary alveolar proteinosis (aPAP).

The REASON for doing the study is that no FDA-approved pharmacologic therapy is available for autoimmunePAP. Preliminary clinical trials of inhaled sargramostim in autoimmune PAP patients show promising results, 62%-96% therapeutic response rate at two doses (250 and 500 mcg/day) without any identified safety concerns. At least 73 people with autoimmune PAP have been reported to have received inhaled sargramostim with no identified drug-related adverse effects. The effects on the lung the pharmacokinetics, pharmacodynamics, optimal dose, and treatment duration needed to maximize efficacy remain unknown.

Some USEFUL FACTS about PAP include:

• Autoimmune PAP is a rare lung disease characterized by alveolar surfactant accumulation and resulting hypoxemic respiratory failure.
• Current therapy involves the physical removal of surfactant by a procedure in which the lungs are repeatedly filled with saline and emptied. This procedure, called whole lung lavage, is invasive, inefficient, and not widely available, especially for children.

Some QUESTIONS this study will address are:

1. What are the effects of inhaled sargramostim in the lungs of autoimmune PAP patients?
2. What are the systemic effects of inhaled sargramostim in autoimmune PAP patients?
3. What is a safe starting dose in patients with autoimmune PAP?

About this Study

This is a pilot, open-label, single-dose interventional study of inhaled sargramostim in individuals with autoimmune PAP. We plan to enroll 10 individuals over a 1-year period. Eligible participants will have questionnaires, blood tests and pulmonary function testing, exercise testing and a bronchoscopy with lavage before they receive one dose of inhaled sargramostim (Leukine®) with a nebulizer, similar to a breathing treatment. They will then be admitted to the hospital for an overnight stay and for observation with blood tests and urine tests performed every few hours. The next day the questionnaires, pulmonary function tests, exercise testing, and bronchoscopy with lavage will be repeated before they go home from the hospital. After a month, they will have a phone call with study staff to see how they are doing.

Targeted Enrollment

You are eligible to participate, if:

• You are interested in participating in the study and able to provide written informed consent.
• You have been diagnosed with autoimmune PAP by a doctor, including an abnormal GM-CSF autoantibody test, an abnormal chest CT scan, evidence of impaired GM-CSF signaling, and an A-aDO2 ≥ 15 mm Hg.

You are not eligible to participate if:

• A diagnosis of any other PAP-causing disease
• Autoimmune PAP complicated by:
  • Severe disease at screening/enrollment (A-aD02<50)
  • Clinically significant pulmonary fibrosis
• A history of any clinically significant:
  • Other lung disease
  • Cardiovascular disease
  • Disease requiring use of systemic steroids
  • Blood disease
  • Active/serious lung or systemic infection
  • Persistent or unexplained fever >101^oF within 2 months of study
  • Use of any immunosuppressive medication
  • Women who are pregnant or plan to become pregnant
  • History of active tobacco/e-cig/marijuana use
  • Concomitant or recent use of specific medicines

How to participate:

In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to inquire about participation.

Ohio

Cincinnati Children’s Hospital Medical Center
Contact Name: Colleen Fitzpatrick
Phone: (513) 636-7036
E-mail: Colleen.Fitzpatrick@cchmc.org

California

University of California Los Angeles
Contact Name: Jamal Sharif
Phone: (310) 825-5316
E-mail: JSharif@mednet.ucla.edu

Status: Ongoing

Background

The PURPOSE of this study is to assemble a group of CT images previously collected for other research or clinical purposes from people with rare lung diseases or normal lungs to begin to develop better diagnostic criteria for rare lung disorders in the future.

The REASON for doing the study is that medical progress for rare lung diseases is hampered by how infrequently these diseases occur. Most of these diseases occur in only 1000 – 3000 people in the United States. Most doctors have either never seen anyone with rare lung diseases or only a few cases in their lifetime. Collecting medical imaging information from many people with rare lung diseases will provide enough information to overcome this barrier to advancement.

Some USEFUL FACTS about the rare lung diseases we will study include:

• The rare lung diseases we will study are lymphangioleiomyomatosis (LAM), pulmonary alveolar proteinosis (PAP), Hermansky-Pudlak Syndrome (HPS), and pulmonary alveolar microlithiasis (PAM). We may also add additional rare lung diseases if we are able to acquire suitable images collected from previous studies of these diseases.
• CT images will be analyzed via several types of software.

Some QUESTIONS this study will address are:

1. How do these rare lung diseases progress over time?
2. How can we relate the data we find from CT images from patients with rare lung disease to the clinical symptoms of the patients?

About this Study

This is a retrospective review study of imaging from patients with rare lung diseases. We plan to review images from up to 200 patients with rare lung disease and up to 50 patients with normal lungs.

Targeted Enrollment

We will be looking at this type of CT images:

• Patients who have had chest CT and also have a diagnosis of one of the rare lung diseases
• Patients who have had chest CT and do not have a diagnosis that would indicate lung disease

How to participate:

There is no open enrollment for this study. The study investigators will select previously collected images for review from images acquired from participants who have already provided informed consent previously for research review of their images.

Jason Woods, PhD
Cincinnati Children’s Hospital Medical Center
Phone: 513-803-4463
Adminsitrative assistant: 513-636-9976 (Sonya Harbin)
E-mail: Jason.Woods@cchmc.org

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Status: Ongoing

Background

Administration of stable inert gases (special gases that are very stable) for a variety of medical purposes has occurred for approximately 40 years, such as nuclear medicine scans and anesthetic uses. The process of making inert gases (xenon, in this study) with a signal high enough to be seen on MRI is a new process that allows images of lung ventilation to be produced without any radiation. This allows for better understanding of regional lung defects, disease progression and assessment of therapeutic response. Additionally, this gas MRI can be utilized for many diseases and patients, from pediatrics to older adults and has the benefit of having no ionizing radiation as is present with clinical CT scans.

This Xenon study is a currently approved un-blinded, open-label pilot study conducted by a single site (Cincinnati Children’s Hospital Medical Center). The PURPOSE of the study is to evaluate the usefulness of hyperpolarized Xenon gas MRI for regional assessment of pulmonary function in individuals with rare lung diseases, such as lymphangioleiomyomatosis (LAM), pulmonary alveolar microlithiasis (PAM), pulmonary alveolar proteinosis (PAP) and Hermansky-Pudlak syndrome.

The objectives of this research are:

1. To acquire images of ventilation and dissolved-phase Xenon regional distribution in participants with rare pulmonary disease (to acquire images of how the gas travels and interacts in the lungs).
2. To provide insight and valuable information for shaping the future of MRI with hyperpolarized gases in the role of identifying and characterizing lung defects.
3. To continue to identify the most sensitive Xenon MRI efficacy endpoints (methods) for use in future studies of pulmonary diseases and future therapies.
4. To collect safety data for this imaging technique.

About this Study

This is a cross-sectional study of individuals with rare pulmonary diseases such as LAM, PAM, PAP and Hermansky-Pudlak syndrome to provide insight and valuable information for shaping the future of MRI with hyperpolarized gases in the role of identifying and characterizing lung defects. This study within the Rare Diseases Clinical Research Network includes screening, imaging and follow up for approximately 28 participants with a rare lung disease. Participants will be screened via phone prior to their enrollment. Participants will come to the research site for a single visit for study activities, including MRI imaging. There will be two follow up phone calls at Days 1 and 30 after the study visit.

At screening, participants will be asked to answer questions about their medical history, medications, MRI safety and criteria for participation in the study. Upon arrival for the study visit, MRI safety and medical history will be confirmed. Pulmonary function testing, including spirometry, will be performed along with a modified physical exam and vital signs. The participant’s Total Lung Capacity will be calculated and used to verify the dose of hyperpolarized Xenon. This dose will be utilized during the MRI portion of the study, which will consist of up to 5 Xenon MRI scans (including a calibration scan). Participants will be asked to inhale the hyperpolarized Xenon gas and hold their breath for up to 16 seconds while MRI imaging is acquired. Additionally, normal chest MRIs and UTE chest MRIs (no gas inhalation) may be performed. Participant heart rate and SpO2 will be measured throughout imaging. Follow up with the participant will be done after the procedure (on Day 1 and Day 30).

Targeted Enrollment

To be eligible to participate, you must:

• Have a rare lung disease such as LAM, PAM, PAP or Hermansky-Pudlak syndrome
• Be at least 6 years old
• Be able to hold your breath for up to 16 seconds

You are not eligible to participate if you have:

• Pregnancy or positive pregnancy test
• Symptoms of respiratory infection or chest tightness within the past two weeks
• Baseline oximetry at MRI visit of less than 95% on room air, or less than 95% on a previously prescribed dose of oxygen delivered by nasal cannula
• Claustrophobia or intolerance to imaging
• Any standard MRI exclusions

How to participate:

In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to inquire about participation.

Erin Watters
Cincinnati Children’s Hospital Medical Center
Phone: 513-803-7024
E-mail: erin.watters@cchmc.org

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Status: Recruiting

Background

Lymphangioleiomyomatosis (LAM) is an ongoing lung disease causing cysts that affects approximately 30% of women with tuberous sclerosis complex (TSC), and about 5 women per million in the population at large. Patients with LAM lose the use of their lungs rather quickly.

The average age for diagnosis of LAM is 35 years. Within 10 years of a women having her first symptom, 55% of patients are breathless when walking on flat ground, 20% require supplemental oxygen and 10% are deceased. Recent data suggests the average survival time once symptoms begin to be 15-30 years.

A previous study (MILES) showed that sirolimus stabilized lung function in patients with moderate and severe disease. 

The research questions are:

1. Does low-dose sirolimus treatment preserve lung function in patients with mild LAM?
2. Does low-dose sirolimus have an effect on other lung function measures and biomarkers over a two-year period? 
3. Are there safety concerns when mild LAM patients take sirolimus over a two-year period?

About this Study

The purpose of this research study is to determine if sirolimus delays disease progression in asymptomatic patients with early LAM. Patients will be randomized to receive low-dose sirolimus or placebo, and will be followed every 4 months for 2 years. The benefits and risks of the trial, including privacy issues, will be explained and the consent form will be presented at the first study visit.

A total of approximately 60 people across the country will take part in this study.

Subjects that agree to be in the study will be asked to:

• Sign and date the informed consent form
• Have a physical exam and provide medical history
• Fill out quality of life questionnaires and functional performance questionnaires
• Give approximately 4 teaspoons of blood for chemistries and serum biomarker studies
• Give urine sample for pregnancy test (if of childbearing potential)
• Have Chest x-ray (only during the first visit)
• Complete full pulmonary function tests
• Provider interval history, physical, laboratory, and serum for subsequent biomarker studies (including VEGF-D) every 4 months

Targeted Enrollment

To be eligible to participate, you must:

• Be a female, age 18 or over
• Sign and date the informed consent form
• Have a diagnosis of LAM
• Have FEV1 of >70% predicted
• Have a presence of markers of non-trivial burden of LAM or likely progression based on:
  1. pretrial rate of FEV1  decline of >60cc/yr FEV1, comparing enrollment FEV1 to any prior measurement in the past 3 years, or
  2. baseline supplemental oxygen requirement  with exercise at sea level, or
  3. premenopausal status or VEGF-D ≥ 600 pg/ml and any one of the following:
     1. baseline diffusing capacity for carbon monoxide ≤80% predicted
     2. baseline residual volume ≥120% predicted 
     3. baseline desaturation by 4% or more on six minute walk testing
     4. more than 20 cysts on the carinal cut of the CT

You are not eligible to participate if:

• You have an existing or forthcoming (within 12-18 months) clinical indication for treatment with mTOR inhibitors, based on judgment of site investigator
• Your levels of DLCO are less than 60% predicted
• Your resting room air saturation is less than 90% at sea level
• Your exercise induced desaturation nadir is below 85% on room air at sea level
• You have a history of myocardial infarction, angina or stroke related to atherosclerosis
• You are pregnant, breast feeding, or plan to become pregnant in the next 2.5 years
• You do not use adequate contraception
• You have significant hematologic, renal, metabolic or hepatic abnormality
• You have acute or chronic infection, such as (nontuberculous mycobacteria or active hepatitis B or C infection at initiation of study drug)
• You have had a recent surgery (involving entry into a body cavity or requiring 3 or more sutures) within three weeks of initiation of study drug
• You have used sirolimus, everolimus or investigational treatment for LAM within the 30 days prior to randomization
• You have had a previous lung transplantation or are active on a transplant list
• You are unable to attend scheduled clinic visits or perform pulmonary function testing
• You have pleural effusion or chylous ascites sufficient to affect pulmonary function based on the opinion of the site investigator
• You have had acute pneumothorax within the past month
• You have had a history of malignancy in the past two years, other than squamous or basal cell skin cancer
• You use estrogen containing medications³ within the 30 days prior to randomization
• You have a known allergy to sirolimus

How to participate:

We greatly appreciate your interest in this study.

In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to inquire about participation.

Ohio

Tammy Roads, CCRP
Study Coordinator
University of Cincinnati
Phone: 513-558-2148
E-mail: roadst@ucmail.uc.edu

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