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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 : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Monica Mita, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date March 28, 2017
First Posted Date April 4, 2017
Last Update Posted Date October 5, 2020
Actual Study Start Date March 28, 2017
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 28, 2017)
Response rate [ Time Frame: 3 years ]
To evaluate the proportion of patients with response to targeted study agent(s) in patients with advanced cancers.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 28, 2017)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Personalized Cancer Care at Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
Official Title Personalized Cancer Care at Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
Brief Summary The purpose of this study is to examine the usefulness of matching patients to targeted therapy by analyzing a tumor sample taken at diagnosis and testing it against 50 cancer-associated genes. Targeted therapy is a highly personalized, newer approach to cancer treatment that aims to more precisely identify and attack cancer cells, in an effort to do less damage to normal cells.
Detailed Description

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Fresh or archived tissue Blood
Sampling Method Non-Probability Sample
Study Population Patients with advanced and metastatic solid tumors who have failed standard systemic therapy.
Condition Cancer
Intervention
  • Other: Matched targeted drug treatment
    Matching a specific genetic abnormality (i.e. mutation) with the appropriate targeted drug.
  • 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."
Study Groups/Cohorts
  • Matched
    Matched targeted drug treatment
    Intervention: Other: Matched targeted drug treatment
  • Control
    Unmatched standard of care
    Intervention: Other: Unmatched standard of care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 2, 2019)
200
Original Estimated Enrollment
 (submitted: March 28, 2017)
301
Estimated Study Completion Date April 1, 2023
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Advanced and metastatic solid tumors who have failed standard treatments known to improve survival
  • Female and male adults age 18 and older.
  • ECOG PS 0-2
  • Acceptable hematological, renal, or liver function
  • Patients planning to undergo a systemic treatment
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

  • Significant comorbidities that could interfere with the study (compliance and visits)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Bethany Wendel, RN 310-967-4339 Bethany.Wendel@cshs.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03098576
Other Study ID Numbers IIT2015-20-Mita-CSMCMatch
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Monica Mita, Cedars-Sinai Medical Center
Study Sponsor Cedars-Sinai Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Monica Mita, MD Cedars-Sinal Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date October 2020