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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00757614
Other study ID # CDR0000598879
Secondary ID MREC-SEARCH-CANC
Status Recruiting
Phase N/A
First received September 22, 2008
Last updated August 23, 2013
Start date February 2008

Study information

Verified date April 2010
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Observational

Clinical Trial Summary

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 to cancer and interactions between genes and the environment in patients with cancer in East Anglia, Trent, or West Midlands of the United Kingdom.


Description:

OBJECTIVES:

- To obtain epidemiological information and biological material on a population-based series of cancer cases, including malignant melanoma, lymphoma, bladder, kidney, esophageal, and pancreatic cancer, and brain tumors.

- Identify novel cancer susceptibility genes, by comparison of genotype frequencies in cases with the corresponding frequencies in large control series.

- To estimate the age and sex-specific risks associated with variants in predisposition genes.

- To evaluate interactions between polymorphisms in predisposition genes and potential lifestyle risk factors.

OUTLINE: This is a multicenter study.

Patients complete a detailed epidemiological questionnaire that includes information on education, occupation, smoking habits, alcohol consumption, height, weight, reproductive history (age at menarche, age at pregnancies, parity, and age at menopause), oral contraceptive use, hormone replacement therapy use, family history of cancer, and past medical history.

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 cancer patients recruited for this study, patients with breast, ovarian, endometrial, colorectal, and prostate cancer are recruited for the following related clinical trials: MREC-SEARCH-BREAST, MREC-SEARCH-OVARIAN, MREC-SEARCH-ENDOMETRIAL, MREC-SEARCH-COLORECTAL, and MREC-SEARCH-PROSTATE.


Recruitment information / eligibility

Status Recruiting
Enrollment 14000
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 69 Years
Eligibility DISEASE CHARACTERISTICS:

- Diagnosed with bladder cancer, kidney cancer, esophageal cancer, pancreatic cancer, brain cancer, malignant melanoma, or lymphoma within the past 5 years

- Identified through the Cancer Research Network OR through the cancer registry serving any of the following geographic regions of the United Kingdom:

- East Anglia

- West Midlands

- Trent

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 Design

N/A


Intervention

Genetic:
DNA analysis

polymorphism analysis

Other:
laboratory biomarker analysis

questionnaire administration


Locations

Country Name City State
United Kingdom University of Cambridge Cancer Research UK Cambridge England

Sponsors (1)

Lead Sponsor Collaborator
Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acquisition of epidemiological information and biological material No
Primary Identification of novel cancer susceptibility genes No
Primary Estimation of the age and sex-specific risks associated with variants in predisposition genes No
Primary Evaluation of interactions between polymorphisms in predisposition genes and potential lifestyle risk factors No
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