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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00058877
Other study ID # FABE
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 14, 2003
Last updated March 17, 2010

Study information

Verified date March 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

This research study is trying to determine whether Barrett's esophagus and associated esophageal cancers, specifically esophageal adenocarcinoma are inherited in certain families. Persons who are affected with Barrett's esophagus or esophageal cancer (adenocarcinoma type) are asked to complete a questionnaire that determines their habits and asks a detailed family history. Family members of patients seen at University Hospitals of Cleveland are also being recruited for screening tests of their esophagus. The investigators plan to eventually screen family members at all participating institutions. This research will eventually lead to the identification of inherited genetic changes that cause Barrett's esophagus and esophageal cancer. It will help the investigators develop better methods for preventing or identifying esophageal cancer at an early curable stage.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 650
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Eligible cases will be defined as those patients and their family members who meet the following criteria:

- Barrett's esophagus confirmed by review of pathology and endoscopy report or adenocarcinoma of the esophagus or family members of person with Barrett's esophagus or adenocarcinoma of the esophagus.

- Male or female age 18 or older at time of enrollment or male or female less than 18 years of age at time of enrollment with parental consent.

- Ability to give informed consent, if patient is age 18 or older.

- No history of radiation to the chest or abdomen.

- No history of chemotherapy in the year preceding the initial diagnosis of Barrett's esophagus or esophageal adenocarcinoma.

Study Design

N/A


Locations

Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio
United States University Hospitals of Cleveland Cleveland Ohio
United States Ohio State University Columbus Ohio
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

See also
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Terminated NCT01572987 - Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus N/A
Terminated NCT01976351 - Imaging Enhanced Endoscopy for the Screening of Barrett's Esophagus N/A
Terminated NCT00526786 - Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus Phase 4
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Completed NCT02106910 - Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy N/A
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Completed NCT01281618 - Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus N/A
Completed NCT01439594 - Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation N/A
Completed NCT00844077 - Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus N/A
Completed NCT00586872 - Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus
Completed NCT00588575 - Ramanspectroscopy in Barrett's Esophagus
Recruiting NCT00288119 - Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
Completed NCT02579460 - Reflux-Induced Oxidative Stress in Barrett's Esophagus: Response, Repair, and Epithelial-Mesenchymal-Transition N/A
Completed NCT03813381 - CAlorie and Protein REstriction PROgram in Barrett's Esophagus Patients (CARE-PRO). N/A
Not yet recruiting NCT02033070 - Patient Registry: Radio Frequency Ablation of Barrett's Esophagus Using HALO System N/A
Completed NCT01961778 - Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma N/A