Scripps Polster Breast Care Center Investigational GeneBank (PINK)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Breast Cancer	Other: Blood/saliva samples, historic breast imaging

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.

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	1136 participants
Observational Model:	Cohort
Official Title:	Scripps Polster Breast Care Center Investigational GeneBank
Study Start Date :	July 2008
Actual Primary Completion Date :	June 2015
Actual Study Completion Date :	June 2015

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
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; 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.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Genotyping [ Time Frame: End of study ]
   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

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.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	30 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
Scripps Polster Breast Care Center
La Jolla, California, United States, 92037

Sponsors and Collaborators

Scripps Translational Science Institute

Investigators

Principal Investigator:	Eric J Topol, MD	Scripps Translational Science Institute and Genomic Medicine

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Eric Topol, MD, Director, Scripps Translational Science Institute, Scripps Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00945464 History of Changes
Other Study ID Numbers:	LAJ 08-8001
First Posted:	July 24, 2009
Last Update Posted:	October 16, 2015
Last Verified:	October 2015