Scripps Polster Breast Care Center Investigational GeneBank (PINK)
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ClinicalTrials.gov Identifier: NCT00945464 |
Recruitment Status :
Completed
First Posted : July 24, 2009
Last Update Posted : October 16, 2015
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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 |
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Breast Cancer | Other: Blood/saliva samples, historic breast imaging |
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 |

Group/Cohort | Intervention/treatment |
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No treatment
Women over the age of 30 undergoing breast imaging at the Scripps Polster Breast Care Center.
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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. |
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945464
United States, California | |
Scripps Polster Breast Care Center | |
La Jolla, California, United States, 92037 |
Principal Investigator: | Eric J Topol, MD | Scripps Translational Science Institute and Genomic Medicine |
Responsible Party: | Eric Topol, MD, Director, Scripps Translational Science Institute, Scripps Translational Science Institute |
ClinicalTrials.gov Identifier: | NCT00945464 |
Other Study ID Numbers: |
LAJ 08-8001 |
First Posted: | July 24, 2009 Key Record Dates |
Last Update Posted: | October 16, 2015 |
Last Verified: | October 2015 |