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The Biorepository for Scripps Health


N/A
18 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

The Biorepository for Scripps Health


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Establish a Biorepository of both diseased and normal tissue

Outcome Description:

Establish a Biorepository of both diseased and normal tissue

Outcome Time Frame:

six years

Safety Issue:

No

Principal Investigator

Eric J Topol, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Scripps Translational Science Institute and Genomic Medicine

Authority:

United States: Institutional Review Board

Study ID:

IRB 09-5261

NCT ID:

NCT01006239

Start Date:

November 2009

Completion Date:

Related Keywords:

  • Cancer
  • Cancer

Name

Location

Scripps Mercy Hospital San Diego, California  92103