Genetic Investigation of Solid Tumors Cohort

NCT ID: NCT01005225

Last Updated: 2014-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2014-05-31

Brief Summary

The objective of this study is to obtain blood samples, solid tumor and/or benign hyperplasia samples to learn more about genetic differences that are linked to the formation of solid tumors.

Detailed Description

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 solid tumors. Even though it has been firmly established that if an individual carries these DNA variants they have an increased chance of developing a solid tumor the underlying biological mechanisms for most of these associations are largely unknown.

In addition to inherited DNA variants that are associated with the development of solid tumors it is well established that during the development and growth of solid tumors the DNA in these cancer cells undergo somatic changes (mutations). These somatic DNA changes have been studied over the past decade and frequently are specific chromosomal translocations and amplifications associated with the development of particular solid tumors. In some instances, examining the chromosomal translocation and amplification has lead to the discovery of proteins contributing to solid tumor pathology.

the human 8q24 interval that has strong genetic associations with solid tumor development has also been noted as frequently amplified in solid tumors and serves as a predictor of poor survival in prostate cancers.

Conditions

Prostate Cancer; Colon Cancer

Study Design

• Observational Model Type: COHORT

Study Groups

Solid tumors

Participants 18 years of age or older who have been diagnosed with a solid tumor or benign hyperplasia that needs surgical removal will be included in this study.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age 18 years or older

2. Eligible to have their blood drawn

3. Be reliable, cooperative and willing to comply with all protocol-specified procedures

4. Able to understand and grant informed consent

5. Diagnosis of a solid tumor

Exclusion Criteria

1. Has a significant chronic medical condition which would potentially confound interpretation of the individual's phenotype.

2. Treatment with any investigational agents or devices within thirty days preceding enrollment in the study.

3. Been administered or taken any CNS sedatives or depressants in the 12 hours prior to informed consent process

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scripps Translational Science Institute

OTHER

Sponsor Role: lead

Responsible Party

Eric Topol, MD

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Mason, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Health

Locations

Scripps Health

San Diego, California, United States

Countries

United States

Other Identifiers

HSC# 004835

Identifier Type: -

Identifier Source: org_study_id