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Status unknownNCT00896818Updated Aug 26, 2013

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 in Breast Cancer, sponsored by Cancer Research UK. Status unknown at 1 site in United Kingdom. Open to female participants aged Up to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-26.

Sponsored by Cancer Research UK · Observational

The sponsor has not verified this record recently (last verified Jun 2009), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Ages
Up to 70 Years
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

Browse Breast Neoplasms studies →

Lead sponsor

Cancer Research UK is the lead sponsor of 83 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility 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
05

Study design

Interventions

  • GeneticDNA analysis
  • Geneticgenetic linkage analysis
  • Geneticloss of heterozygosity analysis
  • Geneticpolymorphism analysis
  • Otherlaboratory biomarker analysis
  • Othermedical chart review
  • Otherquestionnaire administration
06

What researchers measure

Primary outcomes

  1. Prevalence of polymorphisms in candidate genes in contralateral patients and controls

  2. Prevalence of alleles in breast cancer patients from multiple-case families and those in blood-unrelated family controls

  3. 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

  4. 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

07

Study locations

1 of 1 sites recruiting
  • London School of Hygiene and Tropical Medicine
    London, England WC1E 7HT, United Kingdom
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00896818
Lead sponsor
Cancer Research UK
First posted
May 12, 2009
Start date
Jan 2005
Primary completion
Jan 2009 (estimated)
Last update
Aug 26, 2013

Study contacts

Julian Peto, MD
principal investigator · London School of Hygiene and Tropical Medicine
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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