Breast CancerNCT00896818
Genes and Other Risk Factors for Second Primary Breast Cancer in Women With Breast Cancer and Their Female Family Members and Friends
An observational study of Breast Cancer, run by Cancer Research UK at 1 site in United Kingdom.
Trial summary
RATIONALE: Studying samples of blood, urine, and tumor tissue in the laboratory from patients with cancer and their female relatives and friends 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 Up to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- DNA analysis, genetic linkage analysis and loss of heterozygosity analysis
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2005to Jan 2009
- 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 Up to 70 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Women who have been diagnosed with contralateral or unilateral breast cancer
- Family controls, including sisters and adult daughters of contralateral cases, female relatives by marriage
- Unrelated controls (i.e., friends)
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Pre- or postmenopausal
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
London School of Hygiene and Tropical Medicine
London, England, WC1E 7HT
Julian Peto, MD, 44-20-7927-2632, julian.peto@lshtm.ac.uk
About this study
Official title: The British Breast Cancer Study - National Cancer Research Network Cohort (BBC-NCRN)
RATIONALE: Studying samples of blood, urine, and tumor tissue in the laboratory from patients with cancer and their female relatives and friends may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at genes and other risk factors for second primary breast cancer in women with breast cancer and in their female family members and friends.
Read the detailed description
OBJECTIVES:
- To identify new breast cancer susceptibility alleles in breast cancer patients and family controls.
- To compare the prevalence of known polymorphisms in genes involved in hormonal activation and degradation pathways in breast cancer patients and family controls.
- To correlate these polymorphisms with quantitative intermediate markers of susceptibility to breast cancer, such as circulating hormone levels and mammographic density.
- To perform linkage analysis to detect new susceptibility genes in larger multiple-case families combined with data on families previously collected by the Institute of Cancer Research.
- To evaluate the relationship between these polymorphisms and hormone levels in relatives and family controls.
- To compare average hormone levels in patients' unaffected first-degree relatives with family controls using urine samples from premenopausal women and urine and/or serum samples from postmenopausal women.
- To perform follow-up in a cohort of unaffected first-degree relatives at moderate-to-high risk of developing breast cancer with prospective questionnaire data and hormone measurements.
OUTLINE: Unaffected and affected first-degree female relatives and family or friend controls undergo blood sample collection once during study. Genomic DNA is purified from the blood samples for genetic analyses. Within a cohort of unaffected first-degree relatives, postmenopausal women also provide a single urine sample for hormonal assays. Hormones analyzed in the serum and/or urine of postmenopausal women include estradiol, estrone, sulphate, prolactin, androstenedione, testosterone, progesterone, 17-hydroxyprogesterone, and SHBG. Unaffected premenopausal women within the cohort provide urine samples on 6 successive days around the midpoint of their menstrual cycle and on one day towards the luteal phase of their menstrual cycle. These samples are analyzed for luteinizing hormone and metabolites of estradiol and progesterone (i.e., creatinine ratios for estrone glucuronide and pregnanediol glucuronide).
Access to case notes, mammograms, and archival tumor blocks and accompanying pathology reports of breast cancer patients and their affected relatives is requested. When tumor samples from both tumors in bilateral cases are available, these samples are analyzed to identify regions of loss of heterozygosity in which both tumors have lost the same chromosomal region.
Cancer patients and controls, including affected or unaffected first-degree relatives, relatives by marriage, or friends complete a questionnaire at baseline to provide information on demographics (i.e., personal and family), cancer diagnosis and treatment (if applicable), and known risk factors for breast cancer (i.e., lifestyle, reproductive behavior, and family history).
Study participants may be followed periodically for cancer incidence and cause-specific mortality.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
- Conditions
- Breast Cancer
- Being tested
- DNA analysis, genetic linkage analysis, loss of heterozygosity analysis, polymorphism analysis, laboratory biomarker analysis
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
genetic linkage analysisGenetic
loss of heterozygosity analysisGenetic
polymorphism analysisGenetic
laboratory biomarker analysisOther
medical chart reviewOther
questionnaire administrationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of polymorphisms in candidate genes in contralateral patients and controls
Prevalence of alleles in breast cancer patients from multiple-case families and those in blood-unrelated family controls
Linkage analysis to detect new susceptibility genes in larger multiple-case families combined with data on families previously collected by the Institute of Cancer Research
Relationships between candidate gene polymorphisms and hormone levels in relatives and controls
Secondary outcomes (1)
Average hormone levels in contralateral patients' first-degree relatives and controls
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJan 2005
- Primary completionJan 2009 (estimated)
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
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Investigators
- Julian Peto, MD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896818
- Sponsor's protocol ID
- CDR0000592728
- Other IDs
- CRUK-BBC-NCRN, UKCRN-1620, MREC--00/1/10, EU-20834
- Status last verified
- Jun 2009
- First submitted
- 9 May 2009
- 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
- The British Breast Cancer Study - National Cancer Research Network Cohort (BBC-NCRN)
- ClinicalTrials.gov ID
- NCT00896818
- Acronym / sponsor ID
- CDR0000592728
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2009 (estimated)
- First posted
- 12 May 2009 (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, urine, and tumor tissue in the laboratory from patients with cancer and their female relatives and friends may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at genes and other risk factors for second primary breast cancer in women with breast cancer and in their female family members and friends.
Detailed description
OBJECTIVES:
- To identify new breast cancer susceptibility alleles in breast cancer patients and family controls.
- To compare the prevalence of known polymorphisms in genes involved in hormonal activation and degradation pathways in breast cancer patients and family controls.
- To correlate these polymorphisms with quantitative intermediate markers of susceptibility to breast cancer, such as circulating hormone levels and mammographic density.
- To perform linkage analysis to detect new susceptibility genes in larger multiple-case families combined with data on families previously collected by the Institute of Cancer Research.
- To evaluate the relationship between these polymorphisms and hormone levels in relatives and family controls.
- To compare average hormone levels in patients' unaffected first-degree relatives with family controls using urine samples from premenopausal women and urine and/or serum samples from postmenopausal women.
- To perform follow-up in a cohort of unaffected first-degree relatives at moderate-to-high risk of developing breast cancer with prospective questionnaire data and hormone measurements.
OUTLINE: Unaffected and affected first-degree female relatives and family or friend controls undergo blood sample collection once during study. Genomic DNA is purified from the blood samples for genetic analyses. Within a cohort of unaffected first-degree relatives, postmenopausal women also provide a single urine sample for hormonal assays. Hormones analyzed in the serum and/or urine of postmenopausal women include estradiol, estrone, sulphate, prolactin, androstenedione, testosterone, progesterone, 17-hydroxyprogesterone, and SHBG. Unaffected premenopausal women within the cohort provide urine samples on 6 successive days around the midpoint of their menstrual cycle and on one day towards the luteal phase of their menstrual cycle. These samples are analyzed for luteinizing hormone and metabolites of estradiol and progesterone (i.e., creatinine ratios for estrone glucuronide and pregnanediol glucuronide).
Access to case notes, mammograms, and archival tumor blocks and accompanying pathology reports of breast cancer patients and their affected relatives is requested. When tumor samples from both tumors in bilateral cases are available, these samples are analyzed to identify regions of loss of heterozygosity in which both tumors have lost the same chromosomal region.
Cancer patients and controls, including affected or unaffected first-degree relatives, relatives by marriage, or friends complete a questionnaire at baseline to provide information on demographics (i.e., personal and family), cancer diagnosis and treatment (if applicable), and known risk factors for breast cancer (i.e., lifestyle, reproductive behavior, and family history).
Study participants may be followed periodically for cancer incidence and cause-specific mortality.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Study design
Who may qualify
- Ages
- Up to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, 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 |
|---|---|---|
| DNA analysis | Genetic | – |
| genetic linkage analysis | Genetic | – |
| loss of heterozygosity analysis | Genetic | – |
| polymorphism analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| medical chart review | Other | – |
| questionnaire administration | Other | – |
Primary outcome
Prevalence of polymorphisms in candidate genes in contralateral patients and controls
Prevalence of alleles in breast cancer patients from multiple-case families and those in blood-unrelated family controls
Linkage analysis to detect new susceptibility genes in larger multiple-case families combined with data on families previously collected by the Institute of Cancer Research
Relationships between candidate gene polymorphisms and hormone levels in relatives and controls
1 secondary outcome
Average hormone levels in contralateral patients' first-degree relatives and controls
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.
London School of Hygiene and Tropical Medicine
London, United Kingdom
Julian Peto, MD principal investigator
London School of Hygiene and Tropical Medicine
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?
Prevalence of polymorphisms in candidate genes in contralateral patients and controls. The study lists 4 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.