Scripps Polster Breast Care Center Investigational GeneBank - Full Text View

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:

Genetics Home Reference related topics: breast cancer

U.S. FDA Resources

Further study details as provided by Eric Topol, MD, Scripps Translational Science Institute:

Primary Outcome Measures:

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.


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)
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:

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

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

ClinicalTrials.gov processed this record on June 26, 2017

Scripps Polster Breast Care Center Investigational GeneBank (PINK)