Esophageal CancerNCT00516347
Studying Genes for Barrett's Esophagus in Brothers and Sisters
An observational study of Esophageal Cancer and Precancerous Condition, run by Medical Research Council at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer, Precancerous Condition
- What is being tested?
- comparative genomic hybridization, genetic linkage analysis and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2002to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Hutchison Cancer Research Unit
Cambridge, England, CB2 2XZ
Rebecca Fitzgerald, MD, 44-1223-763-287, rcf@hutchison-mrc.cam.ac.uk
About this study
Official title: A Sibling Pair Study To Identify Barrett's Oesophagus Susceptibility Genes
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.
Read the 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.
- Conditions
- Esophageal Cancer, Precancerous Condition
- Being tested
- comparative genomic hybridization, genetic linkage analysis, laboratory biomarker analysis, questionnaire administration, study of high risk factors
- Keywords
- adenocarcinoma of the esophagus, esophageal cancer, Barrett esophagus
- Medical subject headings
- Esophageal Neoplasms, Precancerous Conditions, Adenocarcinoma Of Esophagus, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparative genomic hybridizationGenetic
genetic linkage analysisGenetic
laboratory biomarker analysisOther
questionnaire administrationOther
study of high risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Investigators
- Rebecca Fitzgerald, MD, Study chair, Hutchison Cancer Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516347
- Sponsor's protocol ID
- MRC-HCRC-MREC-02/2/57
- Other IDs
- CDR0000561079, EU-20752
- Status last verified
- Oct 2007
- First submitted
- 14 Aug 2007
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sibling Pair Study To Identify Barrett's Oesophagus Susceptibility Genes
- ClinicalTrials.gov ID
- NCT00516347
- Acronym / sponsor ID
- MRC-HCRC-MREC-02/2/57
- Conditions
- Esophageal Cancer, Precancerous Condition
- Keywords
- adenocarcinoma of the esophagus, esophageal cancer, Barrett esophagus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Medical Research CouncilOther government
- Study start
- Jun 2002
- First posted
- 15 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparative genomic hybridization | Genetic | – |
| genetic linkage analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| questionnaire administration | Other | – |
| study of high risk factors | Procedure or surgery | – |
Primary outcome
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
1 secondary outcome
Comparison of the mortality from esophageal adenocarcinoma in family members with heartburn and Barrett's esophagus with deaths from other causes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Fitzgerald, MD study chair
Hutchison Cancer Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Precancerous Condition, run by Medical Research Council at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Familial incidence of heartburn and Barrett's esophagus in first and second degree relatives of patients with Barrett's esophagus. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.