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Scripps Polster Breast Care Center Investigational GeneBank (PINK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00945464
First received: July 22, 2009
Last updated: October 14, 2015
Last verified: October 2015
History of Changes
  Purpose

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 Intervention
Breast Cancer
 Other: Blood/saliva samples, historic breast imaging

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Scripps Polster Breast Care Center Investigational GeneBank

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Scripps Translational Science Institute:

Primary Outcome Measures:
  • Genotyping [ Time Frame: End of study ] [ Designated as safety issue: No ]
    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.

Enrollment: 1136
Study Start Date: July 2008
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility
Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945464

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

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 
Study First Received: July 22, 2009
Last Updated: October 14, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 23, 2016