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OpenTrials
Completed

NCT Number: NCT05420909

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

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.

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Key information

Conditions

Metastatic Colorectal Cancer (mCRC) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Princeton, New Jersey, 08543, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 6 years

  2. 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 15, 2022
Registry last updated
Aug 19, 2022

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.

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