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Scripps Polster Breast Care Center Investigational GeneBank (PINK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00945464
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute

Study Description
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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 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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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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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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Information from the National Library of Medicine

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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
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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Information from the National Library of Medicine

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


Locations
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United States, California
Scripps Polster Breast Care Center
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
Investigators
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Principal Investigator: Eric J Topol, MD Scripps Translational Science Institute and Genomic Medicine
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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