Healthy, no Evidence of DiseaseNCT00757991
Blood Samples From Healthy Volunteers for Genetic Studies in the East Anglia Region of the United Kingdom
An observational study of Healthy, no Evidence of Disease, run by Cancer Research UK at 1 site in United Kingdom.
Trial summary
RATIONALE: Studying samples of blood from healthy volunteers 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 35 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, no Evidence of Disease
- What is being tested?
- polymorphism analysis, laboratory biomarker analysis and questionnaire administration
- How many people
- 4,000 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 35 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Cancer-free participants randomly selected from the age-sex registry of a general practice in the East Anglia region of the United Kingdom
- Two general practices from each district within East Anglia participate (up to 10 total participating practices)
PATIENT CHARACTERISTICS:
- Identified by the participant's general practitioner as fit to contact for this study
- No prior diagnosis of cancer
- 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 Control Collection for Genetic Studies in East Anglia
RATIONALE: Studying samples of blood from healthy volunteers 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 healthy volunteers.
Read the detailed description
OBJECTIVES:
- To obtain blood samples and simple epidemiological information on a population-based series of adult individuals without cancer.
- To establish whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of cancer by comparing the frequency of alterations in these genes with the corresponding frequency in a comparable series of cancer patients.
- To examine the interactions between genetic and non-genetic risk factors.
OUTLINE: This is a multicenter study.
Participants complete a simple epidemiological questionnaire.
Participants undergo blood sample collection. DNA is extracted from these samples for polymorphism analysis of low penetrance cancer susceptibility genes in the following related clinical trials: MREC-SEARCH-CANCER, MREC-SEARCH-PROSTATE, and MREC-SEARCH-BREAST. They may also be used in the analyses of the following related clinical trials: MREC-SEARCH-OVARIAN, MREC-SEARCH-ENDOMETRIAL, MREC-SEARCH-COLORECTAL.
PROJECTED ACCRUAL: A total of 2,000 male and 2,000 female participants will be accrued for this study.
- Conditions
- Healthy, no Evidence of Disease
- Being tested
- polymorphism analysis, laboratory biomarker analysis, questionnaire administration
- Keywords
- healthy, no evidence of disease
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 blood samples and epidemiological information
Investigation of whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of cancer
Examination of the interactions between genetic and nongenetic risk factors
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 Healthy, no Evidence of DiseaseStudies 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
- 4,000 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
- NCT00757991
- Sponsor's protocol ID
- CDR0000598880
- Other IDs
- MREC-SEARCH-CONTROL, 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 Control Collection for Genetic Studies in East Anglia
- ClinicalTrials.gov ID
- NCT00757991
- Acronym / sponsor ID
- CDR0000598880
- Conditions
- Healthy, no Evidence of Disease
- Keywords
- healthy, no evidence of disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 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 healthy volunteers 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 healthy volunteers.
Detailed description
OBJECTIVES:
- To obtain blood samples and simple epidemiological information on a population-based series of adult individuals without cancer.
- To establish whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of cancer by comparing the frequency of alterations in these genes with the corresponding frequency in a comparable series of cancer patients.
- To examine the interactions between genetic and non-genetic risk factors.
OUTLINE: This is a multicenter study.
Participants complete a simple epidemiological questionnaire.
Participants undergo blood sample collection. DNA is extracted from these samples for polymorphism analysis of low penetrance cancer susceptibility genes in the following related clinical trials: MREC-SEARCH-CANCER, MREC-SEARCH-PROSTATE, and MREC-SEARCH-BREAST. They may also be used in the analyses of the following related clinical trials: MREC-SEARCH-OVARIAN, MREC-SEARCH-ENDOMETRIAL, MREC-SEARCH-COLORECTAL.
PROJECTED ACCRUAL: A total of 2,000 male and 2,000 female participants will be accrued for this study.
Study design
Who may qualify
- Ages
- 35 to 69 years
- Sex
- All
- Healthy volunteers
- 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 blood samples and epidemiological information
Investigation of whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of cancer
Examination of the interactions between genetic and nongenetic risk factors
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 Healthy, no Evidence of Disease, 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 blood samples and epidemiological information. The study lists 3 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.