Scripps Polster Breast Care Center Investigational GeneBank (PINK)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00945464
First received: July 22, 2009
Last updated: June 10, 2014
Last verified: June 2014

July 22, 2009
June 10, 2014
July 2008
June 2015   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00945464 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Scripps Polster Breast Care Center Investigational GeneBank
Scripps Polster Breast Care Center Investigational GeneBank

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.

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.

Observational
Observational Model: Cohort
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

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

Breast Cancer
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.
No treatment
Women over the age of 30 undergoing breast imaging at the Scripps Polster Breast Care Center.
Intervention: Other: Blood/saliva samples, historic breast imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
5000
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Female
30 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00945464
LAJ 08-8001
No
Eric Topol, MD, Scripps Translational Science Institute
Scripps Translational Science Institute
Not Provided
Principal Investigator: Eric J Topol, MD Scripps Translational Science Institute and Genomic Medicine
Scripps Translational Science Institute
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP