Genes and Other Risk Factors for Second Primary Breast Cancer in Women With Breast Cancer and Their Female Family Members and Friends
NCT ID: NCT00896818
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
OBSERVATIONAL
2005-01-31
Brief Summary
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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
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* 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
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Keywords
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Interventions
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DNA analysis
genetic linkage analysis
loss of heterozygosity analysis
polymorphism analysis
laboratory biomarker analysis
medical chart review
questionnaire administration
Eligibility Criteria
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Inclusion Criteria
* 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
70 Years
FEMALE
Yes
Sponsors
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Cancer Research UK
OTHER
Principal Investigators
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Julian Peto, MD
Role: PRINCIPAL_INVESTIGATOR
London School of Hygiene and Tropical Medicine
Locations
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London School of Hygiene and Tropical Medicine
London, England, United Kingdom
Countries
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Facility Contacts
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Julian Peto, MD
Role: primary
Other Identifiers
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CRUK-BBC-NCRN
Identifier Type: -
Identifier Source: secondary_id
UKCRN-1620
Identifier Type: -
Identifier Source: secondary_id
MREC--00/1/10
Identifier Type: -
Identifier Source: secondary_id
EU-20834
Identifier Type: -
Identifier Source: secondary_id
CDR0000592728
Identifier Type: -
Identifier Source: org_study_id