NCT00516347

Brief Summary

RATIONALE: Learning about how often heartburn and other risk factors occur in brothers and sisters and other family members of patients with Barrett's esophagus may help identify other individuals at risk and identify genes for Barrett's esophagus. PURPOSE: This clinical trial is studying genes for Barrett's esophagus in brothers and sisters.

Trial Health

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Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2002

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2007

Completed
Last Updated

August 12, 2013

Status Verified

October 1, 2007

First QC Date

August 14, 2007

Last Update Submit

August 9, 2013

Conditions

Esophageal CancerPrecancerous Condition

Keywords

adenocarcinoma of the esophagusesophageal cancerBarrett esophagus

Outcome Measures

Primary Outcomes (3)

  • Familial incidence of heartburn and Barrett's esophagus in first and second degree relatives of patients with Barrett's esophagus

  • Susceptibility genes for Barrett's esophagus in affected sibling pairs

  • Gene-environment interactions, such as smoking, alcohol, and Helicobacter pylori status, on familial susceptibility to heartburn and Barrett's esophagus

Secondary Outcomes (1)

  • Comparison of the mortality from esophageal adenocarcinoma in family members with heartburn and Barrett's esophagus with deaths from other causes

Interventions

comparative genomic hybridizationGENETIC
genetic linkage analysisGENETIC
laboratory biomarker analysisOTHER
questionnaire administrationOTHER
study of high risk factorsPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Sibling pairs will be recruited either from the United Kingdom National Barrett's Oesophagus Registry (UKBOR) of patients with Barrett's esophagus from 37 centers OR from National Health Service hospitals PATIENT CHARACTERISTICS: * Not specified 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 (1)

Hutchison Cancer Research Unit

Cambridge, England, CB2 2XZ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Esophageal NeoplasmsPrecancerous ConditionsAdenocarcinoma Of EsophagusBarrett Esophagus

Interventions

Comparative Genomic HybridizationGenetic Linkage

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Cytogenetic AnalysisGenetic TechniquesInvestigative TechniquesMolecular Diagnostic TechniquesNucleic Acid HybridizationGenetic Phenomena

Study Officials

  • Rebecca Fitzgerald, MD

    Hutchison Cancer Research Unit

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 14, 2007

First Posted

August 15, 2007

Study Start

June 1, 2002

Last Updated

August 12, 2013

Record last verified: 2007-10

Locations

GB(1)