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

August 18, 2022 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08543
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants who were diagnosed with mCRC and received 2L therapy of interest were selected from Flatiron Health's data from January 2013 through March 2019.

2L therapies of interest included:

  • FOLFIRI and bevacizumab
  • FOLFOX and bevacizumab
  • CAPEOX and bevacizumab
  • FOLFIRI and panitumumab
  • FOLFIRI and ziv-aflibercept
  • FOLFOX, bevacizumab and other (non I-O)
  • FOLFIRI, ziv-aflibercept and other (non I-O)
  • FOLFIRI, bevacizumab and other (non I-O)
  • Nivolumab monotherapy
  • Pembrolizumab monotherapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Cohort 1
Participants diagnosed with metastatic colorectal cancer (mCRC) selected from the Flatiron Electronic Health Record database

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to 6 years
Up to 6 years
Duration of Systemic Treatment
Time Frame: Up to 6 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2019

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Actual)

August 19, 2022

Last Update Submitted That Met QC Criteria

August 18, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-7AU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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