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Study of Genes and Environment in Patients With Cancer in East Anglia, Trent, or West Midlands Regions of the United Kingdom

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00757614
Recruitment Status : Unknown
Verified April 2010 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : September 23, 2008
Last Update Posted : August 26, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date September 22, 2008
First Posted Date September 23, 2008
Last Update Posted Date August 26, 2013
Study Start Date February 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: September 22, 2008)
  • Acquisition of epidemiological information and biological material
  • Identification of novel cancer susceptibility genes
  • Estimation of the age and sex-specific risks associated with variants in predisposition genes
  • Evaluation of interactions between polymorphisms in predisposition genes and potential lifestyle risk factors
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Genes and Environment in Patients With Cancer in East Anglia, Trent, or West Midlands Regions of the United Kingdom
Official Title A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Cancer in East Anglia, Trent and West Midlands
Brief 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.

Detailed 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.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Bladder Cancer
  • Brain and Central Nervous System Tumors
  • Esophageal Cancer
  • Intraocular Melanoma
  • Kidney Cancer
  • Lymphoma
  • Melanoma (Skin)
  • Pancreatic Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
Intervention
  • Genetic: DNA analysis
  • Genetic: polymorphism analysis
  • Other: laboratory biomarker analysis
  • Other: questionnaire administration
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 22, 2008)
14000
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT00757614
Other Study ID Numbers CDR0000598879
MREC-SEARCH-CANCER
MREC-07/MRE05/17
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Cancer Research UK
Collaborators Not Provided
Investigators
Study Chair: Paul Pharoah, MD Cancer Research UK
PRS Account National Cancer Institute (NCI)
Verification Date April 2010