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Active, not recruiting Observational

The Young Women's Breast Cancer Study

NCT01468246 · tracked via the Priya Life Science Israel tracker
Phase
Observational
Started
2006-11
Last updated
2026-02-03

Condition(s) studied

Breast Cancer

Study summary

The investigators are conducting a longitudinal cohort study of young women with breast cancer. The investigators identify women age 40 and younger with newly-diagnosed breast cancer from academic and community healthcare institutions. After women consent to the study, they fill-out surveys and give blood samples, and the investigators collect tissue from their breast cancer tumor after it is removed. Women are surveyed every 6 months for the first 3 years after diagnosis, then yearly thereafter for an additional 7 years (for a total follow-up of at least 10 years following diagnosis). The study investigates short and long-term disease and treatment issues, tumor biology and the relationship to patient outcomes, and psychosocial concerns at baseline and in follow-up among a cohort of young women who are newly-diagnosed with breast cancer.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: * Female * Diagnosis of breast cancer * Age 40 or younger at diagnosis * Informed consent obtained from patient * Ability to understand written and spoken English to the extent necessary to complete the questionnaires Exclusion Criteria: * Inability to understand written and spoken English to the extent necessary to complete the questionnaires * Absence of informed consent

Primary outcome measure(s)

  • Identify a cohort of young women (age 40 or younger) newly diagnosed with breast cancer — 10 years
    Characterize the population of young women at diagnosis and in follow-up regarding disease and psychosocial outcomes (e.g., presentation and disease characteristics including evaluating women with metastatic disease, reported frequency and factors associated with genetic testing, treatment patterns and quality of care, short and long-term side effects, and psychosocial concerns including fertility, sexual functioning, and menopausal issues).
  • Specimen Collection — 10 years
    Collect tumor and blood specimens to characterize the tumors, and bank for future studies including molecular evaluations of disease characteristics, genetic variability and hormonal levels in blood.

Trial sites (13)

FacilityCityRegionStatus
University of Colorado Cancer Center Aurora Colorado
Beth-Israel Deaconess Medical Center Boston Massachusetts
Dana-Farber Cancer Institute Boston Massachusetts
Massachusetts General Hospital Boston Massachusetts
MGH/North Shore Cancer Center Danvers Massachusetts
Cape Cod Hospital Hyannis Massachusetts
Lowell General Hospital Lowell Massachusetts
DF/BWCC at Milford Regional Medical Center Milford Massachusetts
Newton-Wellesley Hospital Newton Massachusetts
South Shore Hospital South Weymouth Massachusetts
Mayo Clinic Rochester Minnesota
Dana-Farber/New Hampshire Oncology-Hematology Londonderry New Hampshire
Sunnybrook Health Sciences Centre Toronto Ontario
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01468246 on ClinicalTrials.gov ↗ ← All trials in Israel