NIH Clinical Research Studies

Protocol Number: 06-CH-0119

Active Accrual, Protocols Recruiting New Patients

Title:
Insulin Resistance and Breast Cancer: Implications for Preventive Counseling in Familial and Sporadic Cases
Number:
06-CH-0119
Summary:
This study will characterize risk factors associated with breast cancer development in some patients. In particular, it will examine the role of insulin in breast cancer in patients with and without a family history of the disease.

Women 30 to 70 years old who have been diagnosed with breast cancer and matched control healthy subjects with and without a family history of breast cancer may be eligible for this study.

Participants undergo the following procedures:

-Cancer-genetic counseling session, including family history, risk assessment, genetic testing for BRCA1 and BRCA2 (if criteria is met), interpretation of results and management options

-Medical history, including questions about symptoms or diseases, reproductive history, use of oral contraceptives, body weight, exercise, lifestyle, and demographic issues

-Drawing of family tree

-Examination of medical records

-Blood drawing for genetic and other tests

-CT scan of the abdomen (approximate time < 1 minute)

-Filling out questionnaires

Sponsoring Institute:
National Institute of Child Health and Human Development (NICHD)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Female
Referral Letter Required: No
Population Exclusion(s): Male

Children

Eligibility Criteria:
ELIGIBILITY CRITERIA:

Females (ages 30-70 years old) who have been diagnosed with breast cancer and age matched controls with and without a family history of breast cancer.

The actual selection of patients most appropriate for research and clinical training needs will be made by protocol investigators.

Referrals will be accepted from the patient recruitment office of the NIH, genetic counselors, geneticists, oncologists, and other health care providers in the area or anybody who reads the information about the study on the NIH world wide web site.

Special Instructions:
Currently Not Provided
Keywords:
Breast Cancer
Family History
Pre/Post Menopausal
Prevention
Risk-Factor
Body-Mass-Index
BRCA1
Insulin
Genetic Counseling
Penetrance
Risk Assessment
Recruitment Keyword(s):
Breast Cancer
BRCA1
Family History
Risk Assessment
Healthy Volunteer
HV
Condition(s):
Breast Cancer
Insulin Resistance
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Institute of Child Health and Human Development

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
Dumitrescu RG, Cotarla I. Understanding breast cancer risk -- where do we stand in 2005? J Cell Mol Med. 2005 Jan-Mar;9(1):208-21. Review.

Wolf I, Sadetzki S, Catane R, Karasik A, Kaufman B. Diabetes mellitus and breast cancer. Lancet Oncol. 2005 Feb;6(2):103-11. Review.

Milazzo G, Giorgino F, Damante G, Sung C, Stampfer MR, Vigneri R, Goldfine ID, Belfiore A. Insulin receptor expression and function in human breast cancer cell lines. Cancer Res. 1992 Jul 15;52(14):3924-30.

Active Accrual, Protocols Recruiting New Patients

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