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OpenTrials
Completed

NCT Number: NCT04757311

Metastatic Colorectal Cancer. 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

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Key information

Conditions

Metastatic Colorectal Cancer 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–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medeniyet University Hospital

Istanbul, 81450, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Percentage of use anti-EGFR agents

    Time frame: throughout of treatment, 3 years

    The anti-EGFR agent selection

  2. Progression Free Survival (PFS)

    Time frame: 3 years treatment

    PFS three years after initiation of treatment with anti-EGFR agents

Secondary outcomes

  1. 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.

Other outcomes

  1. Percentage of use biologics in right side tumors.

    Time frame: throughout of treatment, 3 years

    Treatment selection in right side tumors.

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

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

Acronym: RWD-mCRC-001

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2021
Registry last updated
Oct 27, 2021

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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