Breast CancerNCT00757211
Study of Genes and Environment in Patients With Breast Cancer in the East Anglia Region of the United Kingdom
An observational study of Breast Cancer, run by Cancer Research UK at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- polymorphism analysis, laboratory biomarker analysis and questionnaire administration
- How many people
- 6,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2008to 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer within the past 5 years
- Identified through the East Anglian Cancer Registry in the East Anglia region of the United Kingdom
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Cambridge Cancer Research UK
Cambridge, England, CB1 8RN
Contact Person, 44-122-374-0166, paul.pharoah@srl.cam.ac.uk
About this study
Official title: A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Breast 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 to cancer and interactions between genes and the environment in patients with breast cancer.
Read the detailed description
OBJECTIVES:
- To obtain epidemiological information and biological material on a population-based series of breast cancer cases.
- To establish whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of breast cancer by comparing the frequency of alterations in breast cancer patients with the corresponding frequency in controls.
- To define the proportion of breast cancer incidence attributable to mutations in such genes.
- To examine the interactions between genetic and nongenetic risk factors.
- To evaluate the relationship between pathological and clinical characteristics of breast cancers and germline genotype.
OUTLINE: This is a multicenter study.
Patients complete an epidemiological questionnaire that covers standard known breast cancer risk factors including reproductive history, oral contraceptive use, hormone replacement therapy use, family history, and alcohol consumption. The questionnaire will also request identifying information on 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 breast cancer patients recruited for this study, patients with malignant melanoma and lymphoma, colorectal, ovarian, prostate, colorectal, bladder, kidney, pancreatic, and esophageal cancer, and brain tumors are recruited for the following related clinical trials: MREC-SEARCH-COLORECTAL, MREC-SEARCH-OVARIAN, MREC-SEARCH-PROSTATE, MREC-SEARCH-ENDOMETRIAL, and MREC-SEARCH-CANCER.
- Conditions
- Breast Cancer
- Being tested
- polymorphism analysis, laboratory biomarker analysis, questionnaire administration
- Keywords
- breast cancer, male breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polymorphism analysisGenetic
laboratory biomarker analysisOther
questionnaire administrationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Acquisition of epidemiological information and biological material
Investigation of whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of breast cancer
Proportion of breast cancer incidence attributable to mutations in such genes
Examination of the interactions between genetic and nongenetic risk factors
Evaluation of the relationship between pathological and clinical characteristics of breast cancers and germline genotype
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Investigators
- Paul Pharoah, MD, Study chair, Cancer Research UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757211
- Sponsor's protocol ID
- CDR0000598878
- Other IDs
- MREC-SEARCH-BREAST, MREC-07/MRE05/17
- Status last verified
- Sep 2008
- First submitted
- 22 Sep 2008
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Breast Cancer in East Anglia
- ClinicalTrials.gov ID
- NCT00757211
- Acronym / sponsor ID
- CDR0000598878
- Conditions
- Breast Cancer
- Keywords
- breast cancer, male breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Study start
- Feb 2008
- First posted
- 23 Sep 2008 (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: 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 breast cancer.
Detailed description
OBJECTIVES:
- To obtain epidemiological information and biological material on a population-based series of breast cancer cases.
- To establish whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of breast cancer by comparing the frequency of alterations in breast cancer patients with the corresponding frequency in controls.
- To define the proportion of breast cancer incidence attributable to mutations in such genes.
- To examine the interactions between genetic and nongenetic risk factors.
- To evaluate the relationship between pathological and clinical characteristics of breast cancers and germline genotype.
OUTLINE: This is a multicenter study.
Patients complete an epidemiological questionnaire that covers standard known breast cancer risk factors including reproductive history, oral contraceptive use, hormone replacement therapy use, family history, and alcohol consumption. The questionnaire will also request identifying information on 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 breast cancer patients recruited for this study, patients with malignant melanoma and lymphoma, colorectal, ovarian, prostate, colorectal, bladder, kidney, pancreatic, and esophageal cancer, and brain tumors are recruited for the following related clinical trials: MREC-SEARCH-COLORECTAL, MREC-SEARCH-OVARIAN, MREC-SEARCH-PROSTATE, MREC-SEARCH-ENDOMETRIAL, and MREC-SEARCH-CANCER.
Study design
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| polymorphism analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| questionnaire administration | Other | – |
Primary outcome
Acquisition of epidemiological information and biological material
Investigation of whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of breast cancer
Proportion of breast cancer incidence attributable to mutations in such genes
Examination of the interactions between genetic and nongenetic risk factors
Evaluation of the relationship between pathological and clinical characteristics of breast cancers and germline genotype
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 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.
University of Cambridge Cancer Research UK
Cambridge, United Kingdom
Paul Pharoah, MD study chair
Cancer Research UK
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 Breast Cancer, run by Cancer Research UK at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 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?
Acquisition of epidemiological information and biological material. The study lists 5 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 26 Aug 2013.