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Spots Global Cancer Trial Database for The Young Women's Breast Cancer Study

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Trial Identification

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

Conditions

Breast Cancer

Interventions

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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