The Biorepository for Scripps Health (BIF)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01006239
First received: October 29, 2009
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

The investigators propose to establish a Biorepository of both diseased and normal tissue collected from subjects undergoing surgery for solid tumor resection. In cooperation with the Scripps Cancer registry, the investigators will also establish an anonymized database of corresponding clinical information including response to treatment, disease status, and recurrence.

The Biorepository for Scripps Health will be able to process, preserve, and distribute samples to scientific and medical researchers at Scripps.


Condition Intervention
Cancer
Other: No study intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Biorepository for Scripps Health

Resource links provided by NLM:


Further study details as provided by Scripps Translational Science Institute:

Primary Outcome Measures:
  • Establish a Biorepository of both diseased and normal tissue [ Time Frame: six years ] [ Designated as safety issue: No ]
    Establish a Biorepository of both diseased and normal tissue


Biospecimen Retention:   Samples With DNA

We will be collecting solid tumor and adjacent non-diseased tissue from patients undergoing surgical resection of a solid tumor.


Estimated Enrollment: 10000
Study Start Date: November 2009
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Biorepository
Patients undergoing surgical resection of a solid tumor.
Other: No study intervention
The is no study related intervention.

Detailed Description:

Biorepository samples will be utilized in a variety of research studies intended to help in the diagnosis and/or treatment of patients, including the possible identification of therapeutic targets or genetic identifiers of cancers and possibly other diseases. Various technologies including gene expression, genotyping, DNA and RNA sequencing, protein and metabolite analysis may be used in the course of the various studies An exemplary project currently under consideration is one in which Scripps Genomic Medicine is comparing the DNA sequence of both a patient's tumor and their germline DNA to identify genetic differences between the two. These differences could help identify specific pathways that are regulating the tumor and disease thus leading to potentially valuable information in how to treat that individual patient as well as other patients with similar genetic characteristics. In addition, differences between the tumor and germ-line observed in multiple patients could help identify therapeutic targets that are cancer specific. A secondary exemplary project which is currently underway is one in which Scripps Genomic Medicine is undertaking RNA sequencing to identify "fusion genes" which are hybrid genes formed from two previously separate genes and are a type of genetic mutation that has been identified in certain types of cancers including those of the prostate and breast and certain forms of leukemia. Identifying new fusion genes could provide valuable insights into both treatment protocols and new therapeutic targets.

The goal of this project is to expand and improve the bio-repository already established within the Scripps Genomic Medicine (SGM) group. Presently, the collection has been focused on the collection of predominately prostate tumors and blood as the corresponding normal tissue. The current collection is annotated with pathology information and limited medical information collected from the patient during the consenting process; no post surgical information is collected. We believe that collection can be enhanced by (i) modifying the tumor collection process, (ii) simplifying the means of consenting the patients such that it relies upon the general surgical consent and (iii) using de-identified medical data already consolidated in the Cancer registry as a means of annotating the tissue samples.

  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

Subjects over the age of 18 undergoing surgical resection of solid tumor.

Criteria

Inclusion Criteria:

  • Age 18 or older
  • Undergoing surgical resection of solid tumor
  • Completion of general surgical consent (authorizing "pathologist to use his or her discretion in the disposition or use of any tissues removed during surgery or other procedure unless otherwise directed by my physician. I understand that tissues that are removed may be used for teaching purposes as well as research, institutional or commercial".)

Exclusion Criteria:

  • Does not meet all of the inclusion criteria above.
  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: NCT01006239

Locations
United States, California
Scripps Mercy Hospital
San Diego, California, United States, 92103
Sponsors and Collaborators
Scripps Translational Science Institute
Investigators
Principal Investigator: Eric J Topol, MD Scripps Translational Science Institute and Genomic Medicine
  More Information

No publications provided

Responsible Party: Eric Topol, MD, Director, Scripps Translational Science Institute, Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT01006239     History of Changes
Other Study ID Numbers: IRB 09-5261
Study First Received: October 29, 2009
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Scripps Translational Science Institute:
Cancer

ClinicalTrials.gov processed this record on July 22, 2014