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Trial record 1 of 7 for:    Genetic Investigation of Solid Tumors Cohort
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Genetic Investigation of Solid Tumors Cohort

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ClinicalTrials.gov Identifier: NCT01005225
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : June 12, 2014
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute

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.

Condition or disease
Prostate Cancer Colon Cancer

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.

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Official Title: Genetic Investigation of Solid Tumors Cohort
Study Start Date : February 2008
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Solid tumor biological insights [ Time Frame: Study completion ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatient clinic, physician referral

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005225

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United States, California
Scripps Health
San Diego, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
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Principal Investigator: James Mason, MD Scripps Health
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Responsible Party: Eric Topol, MD, Director, Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT01005225    
Other Study ID Numbers: HSC# 004835
First Posted: October 30, 2009    Key Record Dates
Last Update Posted: June 12, 2014
Last Verified: June 2014
Keywords provided by Eric Topol, MD, Scripps Translational Science Institute:
Solid tumor
prostate cancer
colon cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Colonic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Prostatic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases