Metastatic Colorectal Cancer. Real-World Data Analysis. (RWD-mCRC-001)

October 25, 2021 updated by: Mahmut Gumus, Istanbul Medeniyet University

The Treatment Choices, Duration and Outcomes in Patients With Ras Wild Type (RAS WT) Metastatic Colorectal Cancer (mCRC). Retrospective, Multi-Center, Real-World Data Analysis

The Treatment Choices, Duration and Outcomes in Patients with Ras Wild Type (RAS WT) Metastatic Colorectal Cancer (mCRC). Retrospective, Multi-Center, Real-World Data Analysis

Study Overview

Status

Completed

Conditions

Detailed Description

In this study, with the given rationale is to reveal treatment approaches, survival data, side effect profile and their management in our country in RAS WT mCRC patients by means of the real-world data collection.

Study Type

Observational

Enrollment (Actual)

1750

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

  • Turkey
      • Istanbul, Turkey, 81450
        • Istanbul Medeniyet University Hospital

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have been diagnosed within 3-years period before March 2019 will be included.

Description

Inclusion Criteria:

  1. Patients who have been histologically diagnosed with mCRC
  2. Patients over the age of 18
  3. Patients receiving at least a cycle systemic treatment for metastatic disease
  4. RAS wild type patients
  5. Patients who has demographic, histopathological and clinical information

Exclusion Criteria:

  1. Patients diagnosed as mCRC but only referred to BSC
  2. Patients with RAS mutation
  3. Patients who were included in any clinical trial except standard treatments during their treatment

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

Cohorts and Interventions

Group / Cohort
Metastatic Colorectal Cancer Patients
All RAS wild type metastatic colorectal cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of use anti-EGFR agents
Time Frame: throughout of treatment, 3 years
The anti-EGFR agent selection
throughout of treatment, 3 years
Progression Free Survival (PFS)
Time Frame: 3 years treatment
PFS three years after initiation of treatment with anti-EGFR agents
3 years treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Advers events
Time Frame: throughout of treatment, 3 years
Advers event of anti EGFR is defined as any untoward or unfavourable medical occurrence, including any abnormal sign, symptom, or disease, temporally associated with the patient's participation. The CTCAE v.4.0 will use in this research.
throughout of treatment, 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of use biologics in right side tumors.
Time Frame: throughout of treatment, 3 years
Treatment selection in right side tumors.
throughout of treatment, 3 years

Collaborators and Investigators

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

Sponsor

Istanbul Medeniyet University

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)

August 1, 2020

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

August 30, 2020

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONCO-COLON-TURKEY STUDY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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