Genes and Other Risk Factors for Second Primary Breast Cancer in Women With Breast Cancer and Their Female Family Members and Friends

Breast Cancer Clinical Trial

Official title:

The British Breast Cancer Study - National Cancer Research Network Cohort (BBC-NCRN)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00896818
• Other study ID #: CDR0000592728
• Secondary ID: CRUK-BBC-NCRNUKC
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2009
• Last updated: August 23, 2013
• Start date: January 2005

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 70 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• DNA analysis

• genetic linkage analysis

• loss of heterozygosity analysis

• polymorphism analysis

Other:
• laboratory biomarker analysis

• medical chart review

• questionnaire administration

Locations

Country	Name	City	State
United Kingdom	London School of Hygiene and Tropical Medicine	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of polymorphisms in candidate genes in contralateral patients and controls			No
Primary	Prevalence of alleles in breast cancer patients from multiple-case families and those in blood-unrelated family controls			No
Primary	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			No
Primary	Relationships between candidate gene polymorphisms and hormone levels in relatives and controls			No
Secondary	Average hormone levels in contralateral patients' first-degree relatives and controls			No