Genetic Studies in Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582322
First received: December 21, 2007
Last updated: July 17, 2009
Last verified: July 2009
  Purpose

The purpose of this study is to determine the specific genetic alterations associated with breast cancer. This will leat to a better understanding of the genetic causes of breast cancer.


Condition
Breast Cancer
Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Genetic Studies in Breast Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Biospecimen Retention:   Samples With DNA

blood


Enrollment: 483
Study Start Date: February 1992
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Detailed Description:

It is estimated that 175,000 new breast cancer cases and 44,5000 cancer deaths will result from female breast cancer in 1991. One of the most important risk factors is a family history of breast cancer. A susceptibility allele which accounts for a large proportion of familial breast cancer has been localized to chromosome 17q and attempts to clone the susceptibility are proceeding rapidly. The existence of recognized susceptibility loci and the awareness of a significan proportion of genetic predisposition and the associated penetrances remain unknown and are impossible to estimate without bias from previous studies. This study is designed to estimate heterogeniety and prenetrance in a series of unslected families, identify additional breast cancer susceptibility locs, as well as provide resources for gene isolation and mutation analysis studies.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with breast cancer seen at MSKCC and healthy family members.

Criteria

Inclusion Criteria:

  • patient with breast cancer under age 41
  • patient with bilateral breast cancer 41-50 years old or 41-50 years old with a first degree relative (mother, sister, daughter) with breast cancer diagnosed under age 50
  • patient with ovarian cancer with first degree relative with either ovarian cancer diagnosed at any age or breast cancer diagnosed under age 60
  • patient any age with either ovarian or breast cancer who have 2 first degree rleatives with either ovarian cancer diagnosed at any age or breast cancer diagnosed under age 50
  • relatives of any of the above patients will be included in this trial if a genetic abnormality is found in the patient's blood sample

Exclusion Criteria:

N/A

  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: NCT00582322

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Teresa Gilewski, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Teresa Gilewski, MD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582322     History of Changes
Other Study ID Numbers: 92-007
Study First Received: December 21, 2007
Last Updated: July 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast Cancer
Ovarian Cancer
Family History
Genetic Studies

Additional relevant MeSH terms:
Breast Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on August 28, 2014