The Biorepository for Scripps Health (BIF)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: No study 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.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • Scripps Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Biorepository; Patients undergoing surgical resection of a solid tumor.	Other: No study intervention; The is no study related intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish a Biorepository of both diseased and normal tissue	Establish a Biorepository of both diseased and normal tissue	six years

Collaborators and Investigators

• Sponsor: Scripps Translational Science Institute
• Investigators: Principal Investigator: Eric J Topol, MD, Scripps Translational Science Institute and Genomic Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: October 29, 2009
• First Submitted That Met QC Criteria: October 30, 2009
• First Posted (Estimate): November 1, 2009

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Cancer
• Other Study ID Numbers: IRB 09-5261

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No