A Study of Overall Survival in Participants With Metastatic Colorectal Cancer (mCRC)

Metastatic Colorectal Cancer (mCRC) Clinical Trial

Official title:

Overall Survival for Metastatic Colorectal Cancer Patients Matched to CHECKMATE-142

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05420909
• Other study ID #: CA209-7AU
• Status: Completed
• Start date: January 28, 2019
• Est. completion date: April 1, 2019

Study information

• Verified date: August 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to estimate the overall survival (OS) for US participants diagnosed with metastatic colorectal cancer (mCRC) by using Flatiron Health's individual patient level data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: April 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Metastatic Colorectal Cancer (CRC) participants in the Flatiron database as defined

by:

• Diagnosed with CRC (ICD-9 153.x or 154.x or ICD-10 C18x, or C19x, or C20x, or C21x)
• Pathology consistent with CRC
• At least two documented clinical visits on or after January 1, 2013
• Evidence of Stage IV or recurrent metastatic CRC diagnosed on or after January 1, 2013
• Participants with high levels of microsatellite instability (MSI-H) and/or mismatch repair (MMR) protein deficiency (dMMR)
• Participants who received 2L therapy of interest on or after the initial mCRC diagnosis date
• Participants who had at least 1 month medical data during the prior to and post periods; however, participants who died within 1 month after the index date will not be excluded from the study

Exclusion Criteria:

• Participants <18 years of age at index date
• Participants who received clinical trial drug during the prior or post periods

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer (mCRC)

Locations

Country	Name	City	State
United States	Local Institution	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		Up to 6 years
Primary	Duration of Systemic Treatment	Durations were reported for the first line of therapy prior to the second line (2L) therapy of interest, the 2L therapy of interest, the third line of therapy, and the at least fourth line of therapy.	Up to 6 years

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form