Clinical trial NCT01468246: The Young Women's Breast Cancer Study
Official title: Helping Ourselves, Helping Others: The Young Women's Breast Cancer Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Breast Cancer
Cohort
Young Women
Survivorship
Fertility
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2011-11-09
Enrollment: 1302
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes women who are newly-diagnosed with breast cancer. They must be 40 or younger at their diagnosis.

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 criteria: 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 outcomes:
measure: Identify a cohort of young women (age 40 or younger) newly diagnosed with breast cancer
timeFrame: 10 years
measure: Specimen Collection
timeFrame: 10 years
Secondary outcomes:
measure: Identify Predictors of Outcome
timeFrame: 10 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Boston
country: United States
facility: Beth-Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Danvers
country: United States
facility: MGH/North Shore Cancer Center
state: Massachusetts
city: Hyannis
country: United States
facility: Cape Cod Hospital
state: Massachusetts
city: Lowell
country: United States
facility: Lowell General Hospital
state: Massachusetts
city: Milford
country: United States
facility: DF/BWCC at Milford Regional Medical Center
state: Massachusetts
city: Newton
country: United States
facility: Newton-Wellesley Hospital
state: Massachusetts
city: South Weymouth
country: United States
facility: South Shore Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Londonderry
country: United States
facility: Dana-Farber/New Hampshire Oncology-Hematology
state: New Hampshire
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Massachusetts General Hospital
name: Jeffrey Peppercorn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Steven Come, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Mass General/North-Shore Cancer Center
name: Therese Mulvey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lowell General Hospital
name: Blair Ardman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Newton-Wellesley Hospital
name: Lawrence Blaszkowsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cape Cod Hospital
name: Frank G Basile, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Ellen Warner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Virginia Borges, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Kathryn Ruddy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: South Shore Hospital
name: Katherina Zabicki Calvillo, MD, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber/New Hampshire Oncology-Hematology
name: Jeanna Walsh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: DF/BWCC at Milford Regional Medical Center
name: Natalie Sinclair, MD
role: PRINCIPAL_INVESTIGATOR
References:
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