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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00896818
First Posted: May 12, 2009
Last Update Posted: August 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention
Breast Cancer Genetic: DNA analysis Genetic: genetic linkage analysis Genetic: loss of heterozygosity analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis Other: medical chart review Other: questionnaire administration

Study Type: Observational
Official Title: The British Breast Cancer Study - National Cancer Research Network Cohort (BBC-NCRN)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Average hormone levels in contralateral patients' first-degree relatives and controls

Study Start Date: January 2005
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896818


Locations
United Kingdom
London School of Hygiene and Tropical Medicine Recruiting
London, England, United Kingdom, WC1E 7HT
Contact: Julian Peto, MD    44-20-7927-2632    julian.peto@lshtm.ac.uk   
Sponsors and Collaborators
Cancer Research UK
Investigators
Principal Investigator: Julian Peto, MD London School of Hygiene and Tropical Medicine
  More Information

ClinicalTrials.gov Identifier: NCT00896818     History of Changes
Other Study ID Numbers: CDR0000592728
CRUK-BBC-NCRN
UKCRN-1620
MREC--00/1/10
EU-20834
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: August 26, 2013
Last Verified: June 2009

Keywords provided by National Cancer Institute (NCI):
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases