Scripps Polster Breast Care Center Investigational GeneBank

NCT ID: NCT00945464

Last Updated: 2015-10-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1136 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2015-06-30

Brief Summary

Breast cancer is a disease of complex origin with a strong genetic component. The incidence of breast cancer is very high in monozygotic twins of patients, and it is thought that a high proportion and perhaps the majority of breast cancers arise in a small number of genetically susceptible women. Recent studies in human genetics have discovered several intervals in the human genome containing inherited variants that are statistically associated with the propensity to develop breast cancer. The investigators plan to use this knowledge to design a genetic screening test to guide recommendations for breast cancer screening with mammography. If the small group of genetically susceptible women can be identified, more effective breast cancer screening strategies can be implemented. In contrast, a very large proportion of women who undergo yearly mammography are at exceptionally low risk from a genetic perspective. Using genomic guidance could eventually reconfigure the most efficacious strategy to screen women for early detection of breast cancer.

By developing a genetic screening panel based on genetic markers for breast cancer, the investigators will be able to more accurately determine a woman's individual risk for developing breast cancer.

Detailed Description

Women the age of 30 or over who are undergoing screening or diagnostic breast imaging as an out patient at the Scripps Polster Breast Care Center in La Jolla, CA, with at least 5 years of historic breast imaging data available will be eligible to enroll. For this study, consecutive subjects who have completed screening or diagnostic breast imaging at the Scripps Polster Breast Care Center will be enrolled for one day. It is estimated that up to 5000 subjects will be included in the cohort.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT

Study Groups

No treatment

Women over the age of 30 undergoing breast imaging at the Scripps Polster Breast Care Center.

Blood/saliva samples, historic breast imaging

Intervention Type: OTHER

Subjects are required only to provide a blood or saliva sample, relevant personal and family history (if available), and 5 years of historic breast imaging reports.

Interventions

Blood/saliva samples, historic breast imaging

Subjects are required only to provide a blood or saliva sample, relevant personal and family history (if available), and 5 years of historic breast imaging reports.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 30 years or older

2. Be reliable, cooperative and willing to comply with all protocol-specified procedures

3. Able to understand and grant informed consent

4. Be undergoing screening or diagnostic breast imaging

5. Have at least 5 years of breast imaging data available

Exclusion Criteria

1. Have a significant chronic medical condition which, in the Investigator's opinion, would interfere with the subject's participation in the study

2. Have undergone treatment with any investigational agents or devices within thirty days preceding enrollment in the study

3. Have taken any CNS sedation or depressants in past 12 hours

• Minimum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Scripps Translational Science Institute

OTHER

Sponsor Role: lead

Responsible Party

Eric Topol, MD

Director, Scripps Translational Science Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric J Topol, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Translational Science Institute and Genomic Medicine

Locations

Scripps Polster Breast Care Center

La Jolla, California, United States

Countries

United States

Other Identifiers

LAJ 08-8001

Identifier Type: -

Identifier Source: org_study_id