Clinical trial NCT01006239: The Biorepository for Scripps Health
Official title: The Biorepository for Scripps Health
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Keywords: Cancer
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
First posted: 2009-11-01
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects over the age of 18 undergoing surgical resection of solid tumor.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Establish a Biorepository of both diseased and normal tissue
timeFrame: six years
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Mercy Hospital
state: California
Study officials:
affiliation: Scripps Translational Science Institute and Genomic Medicine
name: Eric J Topol, MD
role: PRINCIPAL_INVESTIGATOR
References: