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Trial record 1 of 55 for:    young women AND Breast cancer
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The Young Women's Breast Cancer Study (HOHO)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01468246
First received: November 5, 2011
Last updated: July 25, 2017
Last verified: July 2017
  Purpose
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.

Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Helping Ourselves, Helping Others: The Young Women's Breast Cancer Study

Resource links provided by NLM:


Further study details as provided by Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Identify a cohort of young women (age 40 or younger) newly diagnosed with breast cancer [ Time Frame: 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 [ Time Frame: 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.


Secondary Outcome Measures:
  • Identify Predictors of Outcome [ Time Frame: 10 years ]
    Ultimately, the investigators aim to develop predictors of outcome and identify areas that may be amenable to intervention for young women with breast cancer.


Biospecimen Retention:   Samples With DNA
The investigators are collecting blood and tumor specimens.

Enrollment: 1302
Study Start Date: November 2006
Estimated Study Completion Date: January 2026
Estimated Primary Completion Date: November 2025 (Final data collection date for primary outcome measure)
Groups/Cohorts
Young Women
Young women with newly diagnosed 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

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468246

Locations
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Massachusetts
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
MGH/North Shore Cancer Center
Danvers, Massachusetts, United States, 01923
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
DF/BWCC at Milford Regional Medical Center
Milford, Massachusetts, United States, 01757
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
South Shore Hospital
South Weymouth, Massachusetts, United States, 02190
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Hampshire
Dana-Farber/New Hampshire Oncology-Hematology
Londonderry, New Hampshire, United States, 03053
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, 3M5
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Lidia Schapira, MD Massachusetts General Hospital
Principal Investigator: Steven Come, MD, MPH Beth Israel Deaconess Medical Center
Principal Investigator: Therese Mulvey, MD Mass General/North-Shore Cancer Center
Principal Investigator: Blair Ardman, MD Lowell General Hospital
Principal Investigator: Caroline Block, MD Newton-Wellesley Hospital
Principal Investigator: Frank G Basile, MD Cape Cod Healthcare
Principal Investigator: Ellen Warner, MD Sunnybrook Health Sciences Centre
Principal Investigator: Virginia Borges, MD University of Colorado, Denver
Principal Investigator: Kathryn Ruddy, MD, MPH Mayo Clinic
Principal Investigator: Katherina Zabicki Calvillo, MD, FACS South Shore Hospital
Principal Investigator: Jeanna Walsh, MD Dana-Farber/New Hampshire Oncology-Hematology
Principal Investigator: Natalie Sinclair, MD DF/BWCC at Milford Regional Medical Center
  More Information

Publications:

Responsible Party: Ann H. Partridge, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01468246     History of Changes
Other Study ID Numbers: 06-169
Study First Received: November 5, 2011
Last Updated: July 25, 2017

Keywords provided by Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute:
Breast Cancer
Cohort
Young Women
Survivorship
Fertility

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 18, 2017