NCT00903591

Brief Summary

This study is being done to find out what factors may be related to the risk of getting a second breast cancer among women who already have breast cancer in one breast. It will look at how genes, treatment for breast cancer; including radiation therapy, and the effects of different lifestyle activities, may affect the risk of breast cancer. It will use different processes to find genes that might increase the risk of breast cancer. The results of this study may help to develop better ways to detect, treat and prevent breast cancer. This study will compare women who have breast cancer in both breasts to women who have breast cancer in only one breast.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,699

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
3 countries

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2009

Completed
17 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

June 3, 2025

Status Verified

June 1, 2025

Enrollment Period

17 years

First QC Date

May 15, 2009

Last Update Submit

June 2, 2025

Conditions

Breast Cancer

Keywords

Breastcancer09-040blood samplesaliva sampleWECAREGWA

Outcome Measures

Primary Outcomes (1)

  • Identify single nucleotide polymorphism's that are associated with contralateral breast cancer using a two-stage approach in a population-based case-control study.

    2.5 years

Secondary Outcomes (3)

  • Identify single nucleotide polymorphism that interact with radiation exposure.

    2.5 years

  • Replication. Using the entire WECARE Study population, determine whether genomic regions found to be associated with unilateral breast cancer as identified via independent genome-wide association studies conducted by other research groups.

    2.5 years

  • Characterize genomic regions containing variants associated with contralateral breast cancer and/or radiation-induced breast cancer in a population-based nested case-control study design.

    2.5 years

Study Arms (1)

1

All women will be interviewed by telephone using the a similar questionnaire as used in the parent study. DNA samples will be obtained either via blood samples drawn during a home or clinic visits, or an Oragene Saliva DNA Self-Collection Kit sent to the participant's home.

Other: questionaire, blood or saliva sample

Interventions

questionaire, blood or saliva sampleOTHER

Take part in an approximately 45 minute telephone interview, with questions about detailed treatment (chemotherapy, hormonal therapy, radiation therapy (RT)) for all study participants. Their medical records will be reviewed to get further details about treatment of their breast cancer. They donate either a 35 ml blood sample (about 3 tablespoons) or a saliva sample. Blood Sample: if patient consents to give a blood sample, following the interview, they will be contacted by our staff phlebotomist (a person trained to draw blood). A scheduled appointment to draw a blood sample from you at your home. At the time of the blood draw, the phlebotomist will collect approximately 2 and 1/3 tablespoons of blood. Saliva Sample: if they choose not to give a blood sample, but consent to give a saliva sample instead, a saliva kit will be sent to there home. Once they provide the sample in the kit, they will be asked to mail back the sample in the pre-labeled kit that was sent to them.

Also known as: The women who consented to 'future contact' in the WECARE:GWAS Study will be, identified, approached, and interviewed by investigative teams in the five data collection sites, (CPIC, MSHT, FHCRC, Iowa, and DCS) over approximately 8 months. Across all data, collection sites, we will approach all eligible cases and controls who consented to future contact, and request participation in the follow-up study to complete the structured questionnaire either, via mail or telephone.
1

Eligibility Criteria

Age18 Years - 54 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All of the WECARE:GWA Study participants (new cases and individually matched controls) will be identified, recruited, and interviewed by investigative teams in the five population-based cancer registries (NCC, OCR, FHCRC, Iowa, and DCS).

You may qualify if:

  • Eligibility for Cases: All women who meet the following eligibility requirements will be recruited as cases for the WECARE:GWA Study if they are not already cases (or refusers) from the parent WECARE Study:
  • Diagnosed since 1/1/1990 with a histologically confirmed first primary breast cancer (only invasive stage 1 or 2) while residing in one of the study enrollment site (cancer registry);
  • Diagnosed since 1/1/1992 with CBC (invasive only any stage) while residing in the same enrollment site (cancer registry);
  • Two years or longer time interval between first and second primaries; Between the ages of 18 and 54 at the time of diagnosis of the first primary;
  • Alive at time of contact; and
  • No history of previous or intervening cancer diagnosis, except cervical cancer in situ (CIS) or non-melanoma skin cancer.
  • Without bilateral mastectomy or prophylactic mastectomy of the contralateral breast following diagnosis of their first primary.
  • Eligibility for Controls: Women who meet all of the following requirements will be eligible as controls. One matched control will be recruited for each participating case:
  • Diagnosed since 1/1/1990 with their first primary breast cancer (only invasive stage 1 or 2) while residing in one of the study enrollment site (i.e., cancer registry);
  • Between the ages of 18 and 54 at the time of diagnosis of the first primary;
  • Residing in the same study enrollment site (cancer registry) as when they were diagnosed with their breast cancer;
  • Alive at time of contact;
  • Never diagnosed (at reference date (date of first diagnosis plus "at risk interval" of matched case)) as having had CBC or any other cancer diagnosis other than the original breast cancer; with the exception of CIS or non-melanoma skin cancer.
  • Without bilateral mastectomy or prophylactic mastectomy of the contralateral breast following diagnosis of their first primary.
  • Enrollment site (cancer registry);
  • +3 more criteria

You may not qualify if:

  • Unable to speak English in U.S. or Canadian enrolling sites or Spanish in the California site, and Danish in Denmark
  • Unable to sign informed consent
  • Stage IV distant metastases for either the first or second primary (lymph node metastasis is acceptable, but there should be no organ involvement
  • Simultaneous diagnosis of invasive in one breast and in situ in the other breast
  • Unable to speak English in U.S. and Canadian enrolling sites, or Spanish in the California site and Danish in Demark
  • Unable to sign informed consent
  • Stage IV distant metastases (lymph node metastasis is acceptable, but there should be no organ involvement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Stanford University

Stanford, California, 94305, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

ONTARIO CANCER REGISTRY, Mount Sinai Hospital, Toronto

Toronto, Ontario, M5G 1X5, Canada

Location

Danish Cancer Society

Copenhagen, Denmark

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

blood sample or saliva sample

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Interventions

Blood Specimen CollectionCycloserine

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesIsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazolidinonesOxazolesSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Jonine Bernstein, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2009

First Posted

May 18, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

June 3, 2025

Record last verified: 2025-06

Locations

DK(1)CA(1)US(4)