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Clinical Trials/NCT03098576
NCT03098576
Completed
Not Applicable

Personalized Cancer Care at Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute

Cedars-Sinai Medical Center1 site in 1 country52 target enrollmentMarch 28, 2017
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Cedars-Sinai Medical Center
Enrollment
52
Locations
1
Primary Endpoint
Response rate
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 28, 2017
End Date
March 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Monica Mita

Associate Professor of Medicine

Cedars-Sinai Medical Center

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)

Outcomes

Primary Outcomes

Response rate

Time Frame: 3 years

To evaluate the proportion of patients with response to targeted study agent(s) in patients with advanced cancers.

Secondary Outcomes

  • Overall survival(3 years)
  • Progression free survival(6 months)

Study Sites (1)

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