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Brief Title: The Young Women's Breast Cancer Study
Official Title: Helping Ourselves, Helping Others: The Young Women's Breast Cancer Study
Study ID: NCT01468246
Brief 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.
Detailed Description: This is a longitudinal cohort study of young women with breast cancer. Over a 6-year period, the investigators aim to identify over 1,600 women age 40 and younger with newly diagnosed breast cancer from academic and community health care institutions. It is anticipated that 1,300 of these women will agree to participate in an observational study. Patient surveys, medical record review, and blood and tissue collection will be utilized. Women will be 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 10 year following diagnosis). The study will investigate short and long-term disease and treatment issues, and psychosocial concerns at baseline and in follow-up among a cohort of young women (age 40 or younger) newly diagnosed with breast cancer. The investigators aim to characterize the population of young women at diagnosis and in follow-up regarding disease and psychosocial outcomes (e.g., presentation and disease characteristics, treatment patterns and quality of care, short and long-term side effects, and psychosocial concerns including fertility, sexual functioning, and menopausal issues). The investigators will also 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. Ultimately, the investigators aim to develop predictors of outcome, and identify areas that may be amenable to intervention.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Colorado Cancer Center, Aurora, Colorado, United States
Beth-Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
MGH/North Shore Cancer Center, Danvers, Massachusetts, United States
Cape Cod Hospital, Hyannis, Massachusetts, United States
Lowell General Hospital, Lowell, Massachusetts, United States
DF/BWCC at Milford Regional Medical Center, Milford, Massachusetts, United States
Newton-Wellesley Hospital, Newton, Massachusetts, United States
South Shore Hospital, South Weymouth, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Dana-Farber/New Hampshire Oncology-Hematology, Londonderry, New Hampshire, United States
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Name: Jeffrey Peppercorn, MD
Affiliation: Massachusetts General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Steven Come, MD, MPH
Affiliation: Beth Israel Deaconess Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Therese Mulvey, MD
Affiliation: Mass General/North-Shore Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Blair Ardman, MD
Affiliation: Lowell General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Lawrence Blaszkowsky, MD
Affiliation: Newton-Wellesley Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Frank G Basile, MD
Affiliation: Cape Cod Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Ellen Warner, MD
Affiliation: Sunnybrook Health Sciences Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Virginia Borges, MD
Affiliation: University of Colorado, Denver
Role: PRINCIPAL_INVESTIGATOR
Name: Kathryn Ruddy, MD, MPH
Affiliation: Mayo Clinic
Role: PRINCIPAL_INVESTIGATOR
Name: Katherina Zabicki Calvillo, MD, FACS
Affiliation: South Shore Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Jeanna Walsh, MD
Affiliation: Dana-Farber/New Hampshire Oncology-Hematology
Role: PRINCIPAL_INVESTIGATOR
Name: Natalie Sinclair, MD
Affiliation: DF/BWCC at Milford Regional Medical Center
Role: PRINCIPAL_INVESTIGATOR