Markers for Breast Cancer

NCT00339248 | Completed

• 2 other identifiers: 99990506105-C-N061
• Study Type: observational
• Target: 2,632
• Locations: 1 country
• Sites: 1

Brief Summary

This study will analyze blood samples to identify substances that are associated with the development of breast cancer. It will determine if:

• Women who are diagnosed with a benign breast condition that is related to a considerably increased risk of breast cancer are more likely to have certain gene variants than women diagnosed with conditions related to very little increased breast cancer risk
• Women with benign breast conditions who subsequently develop breast cancer are more likely to have certain gene variants than women with similar benign conditions who do not develop breast cancer. This study will examine blood samples from premenopausal women who underwent breast biopsy (removal of a small piece of breast tissue for microscopic examination) at four hospitals in Grand Rapids, MI, from 1977 to 1987 and were found to have benign breast disease. The women, who agreed to participate in a study of markers for breast cancer, also provided a blood sample and were interviewed for information on their breast cancer risk factors, family history of breast cancer, use of medications, and history of medical conditions. This study will retrieve the biopsy reports for these women, determine which of them later developed breast cancer, and perform genotyping on their blood samples. The information from this study may help in future diagnosis and treatment of breast cancer.

Conditions

Breast Cancer

Keywords

Hyperplasia; Atypia; Polymorphism; Progression; Epidemiology

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Potentially eligible premenopausal women include 2636 who did not have a previous or concurrent (within 60 days) diagnosis of breast cancer at the time of initial benign breast biopsy (study entry) and who have at least 4 mls of serum stored in the Frederick biorepository.
• Of those 2636, four women have a code indicating "refused study" in the "follow-up" variable, and despite evidence of their consent to the original study, will be omitted from all future use of study data or specimens.
• Participants also will be required to be Caucasian or African American (2599 or 98.6%), and to have a pathology report successfully retrieved from a participating hospital for review.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

NCI Frederick Cancer Research Center

Frederick, Maryland, 21702-1201, United States

Location

Related Publications (3)

• Alle KM, Henshall SM, Field AS, Sutherland RL. Cyclin D1 protein is overexpressed in hyperplasia and intraductal carcinoma of the breast. Clin Cancer Res. 1998 Apr;4(4):847-54.

  PMID: 9563877 BACKGROUND

• Blomeke B, Bennett WP, Harris CC, Shields PG. Serum, plasma and paraffin-embedded tissues as sources of DNA for studying cancer susceptibility genes. Carcinogenesis. 1997 Jun;18(6):1271-5. doi: 10.1093/carcin/18.6.1271.

  PMID: 9214613 BACKGROUND

• Boyd NF, Jensen HM, Cooke G, Han HL. Relationship between mammographic and histological risk factors for breast cancer. J Natl Cancer Inst. 1992 Aug 5;84(15):1170-9. doi: 10.1093/jnci/84.15.1170.

  PMID: 1635085 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Hyperplasia; Disease Progression

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: December 1, 2004
• Last Updated: March 13, 2009

Record last verified: 2007-10

Locations

US (1)