Genetic Investigation of Solid Tumors Cohort

NCT01005225 | Completed

• 1 other identifier: HSC# 004835
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Colon Cancer

Keywords

Solid tumor; prostate cancer; colon cancer

Outcome Measures

Primary Outcomes (1)

• Solid tumor biological insights

  Obtain blood samples, solid tumor and/or benign hyperplasia samples, and in some instances normal tissue in order to gain biological insights into cancer (solid tumors) through population genetics and genomics.

  Study completion

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatient clinic, physician referral

You may qualify if:

• Age 18 years or older
• Eligible to have their blood drawn
• Be reliable, cooperative and willing to comply with all protocol-specified procedures
• Able to understand and grant informed consent
• Diagnosis of a solid tumor

You may not qualify if:

• Has a significant chronic medical condition which would potentially confound interpretation of the individual's phenotype.
• Treatment with any investigational agents or devices within thirty days preceding enrollment in the study.
• Been administered or taken any CNS sedatives or depressants in the 12 hours prior to informed consent process

Sponsors & Collaborators

• Scripps Translational Science Institute: lead

Study Sites (1)

Scripps Health

San Diego, California, 92037, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Approximately 19.5 milliliters (mls) of blood will be collected in (2 x 8.5 ml) PAXgene DNA tubes and (1 x 2.5 ml) PAXgene RNA tube. Solid tumor and/or benign hyperplasia samples will be collected from the participants during surgery scheduled for standard medical care.

MeSH Terms

Conditions

Prostatic Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• James Mason, MD

  Scripps Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 30, 2009
• Study Start: February 1, 2008
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 12, 2014

Record last verified: 2014-06

Locations

US (1)