Personalized Cancer Care at Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03098576|
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : November 6, 2018
|Condition or disease||Intervention/treatment|
|Cancer||Other: Matched targeted drug treatment Other: Unmatched standard of care|
Targeted therapy in this study can be either off label-use of a U.S. Food and Drug Administration (FDA) approved drug or a clinical trial that includes investigational drugs. Matched targeted therapy outcomes will be compared to the outcomes of patients who were not matched to a treatment.
In order to find a matched treatment, a patient's sample will undergo a test known as a "gene chip algorithm." This is will be done by having a sample of a patient's tumor analyzed at a Cedars-Sinai Medical Center (CSMC) laboratory that specializes in molecular profiling. Molecular profiling is a process used to study a tumor's genetic characteristics. DNA will be taken from the tumor sample and will be screened for "actionable genes." These genes are called actionable because mutations (structural changes) in these genes have FDA-approved matched therapies or are eligible for current clinical studies.
|Study Type :||Observational|
|Estimated Enrollment :||301 participants|
|Official Title:||Personalized Cancer Care at Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute|
|Actual Study Start Date :||March 28, 2017|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||April 1, 2021|
Matched targeted drug treatment
Other: Matched targeted drug treatment
Matching a specific genetic abnormality (i.e. mutation) with the appropriate targeted drug.
Unmatched standard of care
Other: Unmatched standard of care
All patients with either no identified mutation or no available matching treatment but undergoing a systemic treatment will be enrolled in the "control group."
- Response rate [ Time Frame: 3 years ]To evaluate the proportion of patients with response to targeted study agent(s) in patients with advanced cancers.
- Progression free survival [ Time Frame: 6 months ]To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced cancers.
- Overall survival [ Time Frame: 3 years ]Evaluate time until death.
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): NCT03098576
|Contact: Bethany Wendel, RN||310-967-4339||Bethany.Wendel@cshs.org|
|United States, California|
|Cedars-Sinai Medical Center||Recruiting|
|Los Angeles, California, United States, 90048|
|Contact: Bethany Wendel, RN 310-967-4339 Bethany.Wendel@cshs.org|
|Principal Investigator: Monica Mita, MD|
|Principal Investigator:||Monica Mita, MD||Cedars-Sinal Medical Center|