Studying Genes for Barrett's Esophagus in Brothers and Sisters - Full Text View

Sponsor:	Medical Research Council
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00516347

Purpose

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.

Condition	Intervention
Esophageal Cancer Precancerous Condition	Genetic: comparative genomic hybridization Genetic: genetic linkage analysis Other: laboratory biomarker analysis Other: questionnaire administration Procedure: study of high risk factors

Study Type:	Observational
Official Title:	A Sibling Pair Study To Identify Barrett's Oesophagus Susceptibility Genes

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Heartburn Smoking and Youth

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Familial incidence of heartburn and Barrett's esophagus in first and second degree relatives of patients with Barrett's esophagus [ Designated as safety issue: No ]
Susceptibility genes for Barrett's esophagus in affected sibling pairs [ Designated as safety issue: No ]
Gene-environment interactions, such as smoking, alcohol, and Helicobacter pylori status, on familial susceptibility to heartburn and Barrett's esophagus [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of the mortality from esophageal adenocarcinoma in family members with heartburn and Barrett's esophagus with deaths from other causes [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	June 2002

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516347

Locations

United Kingdom
Hutchison Cancer Research Unit	Recruiting
Cambridge, England, United Kingdom, CB2 2XZ
Contact: Rebecca Fitzgerald, MD 44-1223-763-287 rcf@hutchison-mrc.cam.ac.uk

Sponsors and Collaborators

Medical Research Council

Investigators

Study Chair:

Rebecca Fitzgerald, MD

Hutchison Cancer Research Unit

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00516347 History of Changes
Other Study ID Numbers:	CDR0000561079, MRC-HCRC-MREC-02/2/57, EU-20752
Study First Received:	August 14, 2007
Last Updated:	January 27, 2010
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the esophagus
esophageal cancer
Barrett esophagus

Additional relevant MeSH terms:

Barrett Esophagus
Disease
Esophageal Diseases
Esophageal Neoplasms
Precancerous Conditions
Digestive System Abnormalities
Digestive System Diseases

Gastrointestinal Diseases
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012