7801: OMEGA - A Prospective, Multicenter Study to Compare and Validate Endoscopic, Histologic, Molecular, and Patient-Reported Outcomes in Pediatric and Adult Patients with Eosinophilic Esophagitis (EoE), Gastritis (EG) and Colitis (EC)

CEGIR is currently RECRUITING for the following clinical trial:

Outcome Measures for Eosinophilic Gastrointestinal Diseases across Ages
A Prospective, Multicenter Study to Compare and Validate Endoscopic, Histologic, Molecular, and Patient-Reported Outcomes in Pediatric and Adult Patients with Eosinophilic Esophagitis (EoE), Gastritis (EG), and Colitis (EC)

This research study is funded by the National Institute of Allergy and Infectious Disease (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of Rare Diseases Research (ORDR), National Center for Advancing Translational Sciences (NCATS).

CEGIR is conducting this study because they want to learn more about Eosinophilic Gastrointestinal Diseases (EGIDs). As part of that goal, one area of study will compare how well a patient feels – their symptoms – with what the tissue samples look like under a microscope. The study aims to answer a series of questions, including the following:

  • What if the tissue looks good, but you are still experiencing symptoms?
  • What if the symptoms have subsided, but the eosinophil counts haven’t changed?

This study is designed to give researchers and clinicians a better idea of the correlation of symptoms to the tissue, help them find clues about the disease in the tissue samples, and assess how this information could be used in the future to help guide diagnosis and treatment plans.

OMEGA is a multicenter, longitudinal study of children and adults with EoE, EG, and EC.

A longitudinal study collects information from the same group of patients over a long period of time. When studying rare diseases, researchers usually have to conduct small trials with fewer patients, and that means they have less information to study. For this trial, which is expected to last at least 5 years, multiple centers across the US will enroll patients and share the information among many researchers. This means there will be more patients, more information, and more researchers to study EGIDs.

No. The OMEGA study is an “observational” research study. It will not interfere with, change, or otherwise intervene with your treatment plan.

If you consent to participate in this study, researchers will follow the progress of your treatment plan. As part of the standard monitoring process for EGIDs, patients have periodic endoscopies and/or colonoscopies with biopsies. If you participate in OMEGA and are scheduled to have an endoscopy/colonoscopy, researchers may request your permission to take additional tissue and/or blood/saliva samples for the study. Also, as a study participant, you will periodically be asked to complete questionnaires. These questionnaires may take 30-45 minutes to complete.

Please contact a study site for more details of what is involved with participation.

You and your family are in the best position to make the decision about whether or not you wish to participate. Currently, only the clinic sites listed below are enrolling for the OMEGA trial, so travel to/from one of these locations will be necessary for treatment and study participation. Travel and other costs related to the usual care of your eosinophilic disorder will be the responsibility of you and/or your insurer. There is no charge to you or your health insurance company for any costs that are directly related to this observational study. You will receive no payment for participating in OMEGA.

If you are currently under the care of an EGID medical provider/team NOT affiliated with one of the participating clinics, you will need to change health care providers in order to participate in OMEGA (i.e., all OMEGA patients must be receiving treatment for their eosinophilic disease from a doctor at one of the participating clinics).

This study presents a significant opportunity for the EGID patient community to take an active role in helping CEGIR gain a better understanding of EoE, EG, and EC. Every effort will be made to enroll as many patients as possible, but there are no guarantees that everyone who wants to participate will be able to enroll. If you have questions about the trial and/or specifics about what is involved, please contact one of the study coordinators identified below.

  • Children and adults between the age 3 and 65.
  • You (or your child) must have been diagnosed with one of the following*:
    • Eosinophilic Esophagitis (EoE)
    • Eosinophilic Gastritis (EG)
    • Eosinophilic Colitis (EC)
  • You (or your child) must have had symptoms related to your EGID (past or present). If you have few/no symptoms today as the result of current treatment for your EGID, you are still eligible to participate in OMEGA.
  • You (or your child) must have had mucosal eosinophilia (eosinophils in your digestive tract). If you are being treated for an EGID and are presenting with low numbers of eosinophils, you are still eligible to participate in OMEGA.

* Patients with a diagnosis of Eosinophilic Gastroenteritis (EGE) or Eosinophilic Duodenitis (ED) can contact a study coordinator for additional eligibility details.

 

You may not be eligible to participate in OMEGA…

  • If you have a history of intestinal surgery.
  • If you are enrolled in a blinded investigational study.
  • If you have other identifiable causes for eosinophilia, such as infections, gastrointestinal (GI) cancer, and/or another GI inflammatory disease.

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.

California

University of California, San Diego & Rady Children's Hospital, San Diego
Contact: Lea Jacinto, Clinical Research Coordinator 
858-246-2144
ljacinto@ucsd.org

Colorado

Children's Hospital Colorado
Contact: Susanna Kantor, Clinical Research Coordinator 
720-777-4800
susanna.kantor@childrenscolorado.org

University of Colorado
Contact: Allison Dubner, Clinical Research Coordinator 
303-724-8974
allison.dubner@ucdenver.edu

Illinois

Ann & Robert H. Lurie Children's Hospital of Chicago
Contact: Jessica Ross, Clinical Research Coordinator 
312-227-4582
jnross@luriechildrens.org

Northwestern University
Contact: Angelika ZalewskiClinical Research Coordinator 
312-695-4036
angelika.zalewski@northwestern.edu

Massachusetts

Tufts Medical Center
Contact: Pedro Eman, Clinical Research Coordinator
617-636-4941
peman@tuftsmedicalcenter.org

North Carolina

University of North Carolina School of Medicine
Contact: Sarah McGee, Clinical Research Coordinator
919-966-4591
smcgee@med.unc.edu

Ohio

Cincinnati Children's Hospital Medical Center (CCHMC), Cincinnati
Contact: Jonathan Kuhl, Clinical Research Coordinator
513-803-3078
Jonathan.Kuhl@cchmc.org

Pennsylvania

Children's Hospital of Philadelphia
Contact: Deirdre Burke, Clinical Research Coordinator 
267-426-8603
Burked2@email.chop.edu

University of Pennsylvania, Philadelphia
Contact: Maureen DeMarshall, Clinical Research Coordinator 
215-349-8546
demarshm@mail.med.upenn.edu

Future Participating Site(s)

University of Illinois at Peoria/OSF St. Francis Medical Center
Contact: Jocelyn Perry, RNClinical Research Coordinator 
303-624-4087
jocelyn.k.perry@osfhealthcare.org


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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.