Scripps Polster Breast Care Center Investigational GeneBank

NCT00945464 | Completed

• 1 other identifier: LAJ 08-8001
• Study Type: observational
• Target: 1,136
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Genotyping

  Genotype a panel of single nucleotide polymorphisms (SNPs) previously shown to be highly associated with increased risk to breast cancer in a cohort of women with either at least 5 years of historical breast imaging data available or 30-45 year old breast cancer patients with at least one year imaging data

  End of study

Study Arms (1)

No treatment

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

Other: Blood/saliva samples, historic breast imaging

Interventions

Blood/saliva samples, historic breast imaging 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.

No treatment

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age 30 years or older
• Be reliable, cooperative and willing to comply with all protocol-specified procedures
• Able to understand and grant informed consent
• Be undergoing screening or diagnostic breast imaging
• Have at least 5 years of breast imaging data available

You may not qualify if:

• Have a significant chronic medical condition which, in the Investigator's opinion, would interfere with the subject's participation in the study
• Have undergone treatment with any investigational agents or devices within thirty days preceding enrollment in the study
• Have taken any CNS sedation or depressants in past 12 hours

Sponsors & Collaborators

• Scripps Translational Science Institute: lead

Study Sites (1)

Scripps Polster Breast Care Center

La Jolla, California, 92037, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Approximately 19.5 mls of blood will be collected from volunteers. The blood from each subject will be collected via venipuncture. If subject is unable/unwilling to provide blood sample, we can also collect 2 mls of saliva.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Eric J Topol, MD

  Scripps Translational Science Institute and Genomic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Scripps Translational Science Institute

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 24, 2009
• Study Start: July 1, 2008
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

US (1)