search
Back to results

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

Primary Purpose

Bladder Cancer, Brain and Central Nervous System Tumors, Esophageal Cancer

Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
DNA analysis
polymorphism analysis
laboratory biomarker analysis
questionnaire administration
Sponsored by
Cancer Research UK
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Bladder Cancer focused on measuring AIDS-related lymphoma, cutaneous lymphoma, adult Hodgkin lymphoma, adult non-Hodgkin lymphoma, intraocular lymphoma, adult T-cell leukemia/lymphoma, primary central nervous system non-Hodgkin lymphoma, primary central nervous system Hodgkin lymphoma, noncutaneous extranodal lymphoma, adult astrocytic tumors, adult brain stem glioma, adult choroid plexus tumor, adult craniopharyngioma, adult embryonal tumor, adult ependymal tumors, adult meningeal tumor, adult oligodendroglial tumors, adult pineal parenchymal tumor, adult brain tumor, intraocular melanoma, bladder cancer, clear cell sarcoma of the kidney, congenital mesoblastic nephroma, esophageal cancer, melanoma, pancreatic cancer, peripheral primitive neuroectodermal tumor of the kidney, renal cell carcinoma, rhabdoid tumor of the kidney, transitional cell cancer of the renal pelvis and ureter

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Cambridge Cancer Research UKRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 22, 2008
Last Updated
August 23, 2013
Sponsor
Cancer Research UK
search

1. Study Identification

Unique Protocol Identification Number
NCT00757614
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
Study Type
Observational

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cancer Research UK

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
AIDS-related lymphoma, cutaneous lymphoma, adult Hodgkin lymphoma, adult non-Hodgkin lymphoma, intraocular lymphoma, adult T-cell leukemia/lymphoma, primary central nervous system non-Hodgkin lymphoma, primary central nervous system Hodgkin lymphoma, noncutaneous extranodal lymphoma, adult astrocytic tumors, adult brain stem glioma, adult choroid plexus tumor, adult craniopharyngioma, adult embryonal tumor, adult ependymal tumors, adult meningeal tumor, adult oligodendroglial tumors, adult pineal parenchymal tumor, adult brain tumor, intraocular melanoma, bladder cancer, clear cell sarcoma of the kidney, congenital mesoblastic nephroma, esophageal cancer, melanoma, pancreatic cancer, peripheral primitive neuroectodermal tumor of the kidney, renal cell carcinoma, rhabdoid tumor of the kidney, transitional cell cancer of the renal pelvis and ureter

7. Study Design

Enrollment
14000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
DNA analysis
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Primary Outcome Measure Information:
Title
Acquisition of epidemiological information and biological material
Title
Identification of novel cancer susceptibility genes
Title
Estimation of the age and sex-specific risks associated with variants in predisposition genes
Title
Evaluation of interactions between polymorphisms in predisposition genes and potential lifestyle risk factors

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Pharoah, MD
Organizational Affiliation
Cancer Research UK
Official's Role
Study Chair
Facility Information:
Facility Name
University of Cambridge Cancer Research UK
City
Cambridge
State/Province
England
ZIP/Postal Code
CB1 8RN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-122-374-0166
Email
paul.pharoah@srl.cam.ac.uk

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs