Genetic Investigation of Solid Tumors Cohort

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01005225
First received: October 28, 2009
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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.


Condition
Prostate Cancer
Colon Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Genetic Investigation of Solid Tumors Cohort

Resource links provided by NLM:


Further study details as provided by Scripps Translational Science Institute:

Primary Outcome Measures:
  • Solid tumor biological insights [ Time Frame: Study completion ] [ Designated as safety issue: No ]
    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.


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.


Enrollment: 25
Study Start Date: February 2008
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatient clinic, physician referral

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
  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: NCT01005225

Locations
United States, California
Scripps Health
San Diego, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
Investigators
Principal Investigator: James Mason, MD Scripps Health
  More Information

Additional Information:
No publications provided

Responsible Party: Eric Topol, MD, Director, Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT01005225     History of Changes
Other Study ID Numbers: HSC# 004835
Study First Received: October 28, 2009
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Scripps Translational Science Institute:
Solid tumor
prostate cancer
colon cancer

Additional relevant MeSH terms:
Colonic Neoplasms
Prostatic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 27, 2014