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

NCT03098576 | Completed

• 1 other identifier: IIT2015-20-Mita-CSMCMatch
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

advanced; metastatic solid tumors

Outcome Measures

Primary Outcomes (1)

• Response rate

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

  3 years

Secondary Outcomes (2)

• Progression free survival

  6 months

• Overall survival

  3 years

Study Arms (2)

Matched

Matched targeted drug treatment

Other: Matched targeted drug treatment

Control

Unmatched standard of care

Other: Unmatched standard of care

Interventions

Matched targeted drug treatment OTHER

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

Matched

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."

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced and metastatic solid tumors who have failed standard systemic therapy.

You may qualify if:

• 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.

You may not qualify if:

• Significant comorbidities that could interfere with the study (compliance and visits)

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fresh or archived tissue Blood

MeSH Terms

Conditions

Neoplasms

Study Officials

• Monica Mita, MD

  Cedars-Sinal Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 4, 2017
• Study Start: March 28, 2017
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)