Metastatic Colorectal Cancer. Real-World Data Analysis.

Metastatic Colorectal Cancer Clinical Trial

— RWD-mCRC-001  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757311
• Other study ID #: ONCO-COLON-TURKEY STUDY
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2021
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1750
• Est. completion date: October 1, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of use biologics in right side tumors.	Treatment selection in right side tumors.	throughout of treatment, 3 years
Primary	Percentage of use anti-EGFR agents	The anti-EGFR agent selection	throughout of treatment, 3 years
Primary	Progression Free Survival (PFS)	PFS three years after initiation of treatment with anti-EGFR agents	3 years treatment
Secondary	Advers events	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