- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00757965
Study of Genes and the Environment in Patients With Colorectal Cancer in the East Anglia Region of the United Kingdom
A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Colorectal Cancer in East Anglia
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This study is looking at genetic susceptibility for cancer and interactions between genes and the environment in patients with colorectal cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- To obtain epidemiological information and biological material on a population based series of colorectal cancer cases.
- To define the proportion of colorectal cancer incidence attributable to mutations in known predisposing genes such as MLH1 and MSH2.
- To establish whether mutations at other loci may predispose to colorectal cancer, by comparing the frequency of alteration candidate genes in colorectal cancer patients with the corresponding frequency in cancer-free controls identified through the European Prospective Investigation of Cancer (EPIC) study.
OUTLINE: This is a multicenter study.
Patients complete an epidemiological questionnaire. The questionnaire also requests identifying information about the patient's first-degree relatives.
Blood samples are collected from patients. DNA is extracted from these blood samples, from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL, and from additional controls through the European Prospective Investigation of Cancer (EPIC) study (a population-based study of diet and health based in Norfolk, East Anglia). DNA samples are analyzed for polymorphisms of low penetrance cancer susceptibility genes.
In addition to the colorectal cancer patients recruited for this study, patients with breast, ovarian, prostate, colorectal, bladder, kidney, pancreatic, brain, and esophageal cancer, malignant melanoma, and lymphoma cancer are recruited for the following related clinical trials: MREC-SEARCH-BREAST, MREC-SEARCH-OVARIAN, MREC-SEARCH-PROSTATE, MREC-SEARCH-ENDOMETRIAL, and MREC-SEARCH-CANCER.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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England
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Cambridge, England, United Kingdom, CB1 8RN
- Recruiting
- University of Cambridge Cancer Research UK
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Contact:
- Contact Person
- Phone Number: 44-122-374-0166
- Email: paul.pharoah@srl.cam.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Diagnosis of colorectal cancer within the past 5 years
- Identified in the East Anglia region of the United Kingdom
PATIENT CHARACTERISTICS:
- Identified by the patient's general practitioner as fit to contact for this study
- No serious mental illness or retardation
PRIOR CONCURRENT THERAPY:
- Not specified
Study Plan
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Acquisition of epidemiological information and biological material
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Proportion of colorectal cancer incidence attributable to mutations in known predisposing genes (e.g., MLH1 and MSH2)
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Exploration of mutations at other loci that may predispose to endometrial cancer
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Paul Pharoah, MD, Cancer Research UK
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000598882
- MREC-07/MRE05/17
- MREC-SEARCH-COLORECTAL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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