The Biorepository for Scripps Health (BIF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01006239|
Recruitment Status : Active, not recruiting
First Posted : November 1, 2009
Last Update Posted : March 17, 2021
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 or disease||Intervention/treatment|
|Cancer||Other: No study intervention|
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|
|Estimated Enrollment :||10000 participants|
|Official Title:||The Biorepository for Scripps Health|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||January 2023|
Patients undergoing surgical resection of a solid tumor.
Other: No study intervention
The is no study related intervention.
- Establish a Biorepository of both diseased and normal tissue [ Time Frame: six years ]Establish a Biorepository of both diseased and normal tissue
Biospecimen Retention: Samples With DNA
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): NCT01006239
|United States, California|
|Scripps Mercy Hospital|
|San Diego, California, United States, 92103|
|Principal Investigator:||Eric J Topol, MD||Scripps Translational Science Institute and Genomic Medicine|