NCT00445653

Brief Summary

RATIONALE: A study that evaluates DNA changes and other disease-related health information in patients with Barrett's esophagus, gastroesophageal reflux, or gastrointestinal bleeding may help doctors learn more about the risk factors for Barrett's esophagus. PURPOSE: This clinical trial is looking at DNA changes and other disease-related health information as risk factors for Barrett's esophagus in patients with Barrett's esophagus, gastroesophageal reflux, or gastrointestinal bleeding.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2005

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2007

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

7.6 years

First QC Date

March 7, 2007

Last Update Submit

January 13, 2017

Conditions

Precancerous Condition

Keywords

Barrett esophagus

Outcome Measures

Primary Outcomes (4)

  • Polymorphisms in detoxifying enzyme systems such as glutathione S-transferases (e.g., mu, theta, pi)

    2000-2013

  • Polymorphisms in other xenobiotic metabolism pathways (e.g., CYP1A1, CYP2E1, CYP3A4/5, NQO1, mEH, NAT-2)

    2000-2013

  • Polymorphisms in inflammatory gene pathways (e.g., MPO, MnSOD, IGF, IGFBF3, Il1-beta)

    2000-2013

  • Polymorphisms in DNA repair genes or the p53 pathways (e.g., ERCC2, XRCC1, p53, p73, CCND1, p21)

    2000-2013

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients coming in for EGD

DISEASE CHARACTERISTICS: * Undergoing elective esophagogastroduodenoscopy for any of the following reasons: * Surveillance of Barrett's esophagus * Evaluation of severe or refractory gastroesophageal reflux disease or chest pain thought to be due to reflux * Gastrointestinal bleeding PATIENT CHARACTERISTICS: * Not pregnant PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Harvard School of Public Health

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples only were collected

MeSH Terms

Conditions

Precancerous ConditionsBarrett Esophagus

Condition Hierarchy (Ancestors)

NeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • David C. Christiani, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pulmonary Associate

Study Record Dates

First Submitted

March 7, 2007

First Posted

March 9, 2007

Study Start

August 1, 2005

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

January 18, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)