Scripps Polster Breast Care Center Investigational GeneBank

Breast Cancer Clinical Trial

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Official title:

Scripps Polster Breast Care Center Investigational GeneBank

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00945464
• Other study ID #: LAJ 08-8001
• Status: Completed
• Phase: N/A
• First received: July 22, 2009
• Last updated: October 14, 2015
• Start date: July 2008
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Scripps Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1136
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Scripps Polster Breast Care Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genotyping	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	End of study	No