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OpenTrials
Completed

NCT Number: NCT03098576

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Matched targeted drug treatment

Other

Matching a specific genetic abnormality (i.e. mutation) with the appropriate targeted drug.

Unmatched standard of care

Other

All patients with either no identified mutation or no available matching treatment but undergoing a systemic treatment will be enrolled in the "control group."

Primary outcomes

  1. 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

  1. 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.

  2. Overall survival

    Time frame: 3 years

    Evaluate time until death.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Apr 4, 2017
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.