Studying Genes for Barrett's Esophagus in Brothers and Sisters
Primary Purpose
Esophageal Cancer, Precancerous Condition
Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
comparative genomic hybridization
genetic linkage analysis
laboratory biomarker analysis
questionnaire administration
study of high risk factors
Sponsored by
About this trial
This is an observational trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, esophageal cancer, Barrett esophagus
Eligibility Criteria
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
Sites / Locations
- Hutchison Cancer Research UnitRecruiting
Outcomes
Primary Outcome Measures
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 Outcome Measures
Comparison of the mortality from esophageal adenocarcinoma in family members with heartburn and Barrett's esophagus with deaths from other causes
Full Information
NCT ID
NCT00516347
First Posted
August 14, 2007
Last Updated
August 9, 2013
Sponsor
Medical Research Council
1. Study Identification
Unique Protocol Identification Number
NCT00516347
Brief Title
Studying Genes for Barrett's Esophagus in Brothers and Sisters
Official Title
A Sibling Pair Study To Identify Barrett's Oesophagus Susceptibility Genes
Study Type
Observational
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Medical Research Council
4. Oversight
5. Study Description
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.
Detailed Description
OBJECTIVES:
Primary
To investigate the familial incidence of heartburn and Barrett's esophagus in first and second degree relatives of patients with Barrett's esophagus in the United Kingdom.
To determine susceptibility genes for Barrett's esophagus in affected sibling pairs.
To examine gene-environment interactions, such as smoking, alcohol, and Helicobacter pylori status, on familial susceptibility to heartburn and Barrett's esophagus.
Secondary
To compare the mortality from esophageal adenocarcinoma in family members with heartburn and Barrett's esophagus with deaths from other causes.
OUTLINE: This is a multicenter study.
Patients complete a family history questionnaire. Epidemiological data is also collected about environmental exposures, such as smoking and alcohol history. Any siblings or other living family members affected by heartburn identified from this survey are then contacted to validate their symptoms/diagnoses and to collect other relevant epidemiological data. Family members with heartburn are offered a screening endoscopy for the presence of Barrett's esophagus. In the absence of an endoscopy, a symptom nomogram predictive for the presence of Barrett's esophagus is used.
Patients and their siblings, as well as any other willing family member (affected or non-affected) are asked to have a blood sample (EDTA tube for genetic analysis and a serum sample for Helicobacter pylori status) taken by their physician. Genomic DNA is extracted from lymphocytes and a genome-wide scan is performed using a standard marker set. A computer program is used to verify sibling relationships. Individuals not found to be full siblings are excluded from subsequent analyses. Maximum likelihood score (MLS) and the nonparametric linkage score (NPL) is used to estimate the degree of linkage.
All study participants are flagged with the National Health Service (NHS) Central Register to ascertain the future mortality from esophageal adenocarcinoma compared with deaths from other causes.
PROJECTED ACCRUAL: A total of 200 sibling pairs will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Precancerous Condition
Keywords
adenocarcinoma of the esophagus, esophageal cancer, Barrett esophagus
7. Study Design
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
comparative genomic hybridization
Intervention Type
Genetic
Intervention Name(s)
genetic linkage analysis
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
study of high risk factors
Primary Outcome Measure Information:
Title
Familial incidence of heartburn and Barrett's esophagus in first and second degree relatives of patients with Barrett's esophagus
Title
Susceptibility genes for Barrett's esophagus in affected sibling pairs
Title
Gene-environment interactions, such as smoking, alcohol, and Helicobacter pylori status, on familial susceptibility to heartburn and Barrett's esophagus
Secondary Outcome Measure Information:
Title
Comparison of the mortality from esophageal adenocarcinoma in family members with heartburn and Barrett's esophagus with deaths from other causes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Fitzgerald, MD
Organizational Affiliation
Hutchison Cancer Research Unit
Official's Role
Study Chair
Facility Information:
Facility Name
Hutchison Cancer Research Unit
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2XZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Fitzgerald, MD
Phone
44-1223-763-287
Email
rcf@hutchison-mrc.cam.ac.uk
12. IPD Sharing Statement
Learn more about this trial
Studying Genes for Barrett's Esophagus in Brothers and Sisters
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