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

NCT ID: NCT03098576

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-28
• Study Completion Date: 2024-03-01

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.

Conditions

Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Matched

Matched targeted drug treatment

Matched targeted drug treatment

Intervention Type: OTHER

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

Control

Unmatched standard of care

Unmatched standard of care

Intervention Type: 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."

Interventions

Matched targeted drug treatment

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

Intervention Type: 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."

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Monica Mita

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monica Mita, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinal Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

IIT2015-20-Mita-CSMCMatch

Identifier Type: -

Identifier Source: org_study_id