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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Scripps Polster Breast Care Center

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood/saliva samples, historic breast imaging

Other

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Scripps Translational Science Institute

Other

Registry information

Acronym: PINK

Important dates

Study start: 2008
Primary completion: 2015
Study completion: 2015
First posted: Jul 24, 2009
Registry last updated: Oct 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed