Observational Study on Treatment of Metastatic Colorectal Cancer and the Role of K-Ras

Active, not recruiting

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT01651013
• Lead Sponsor: National Cancer Institute, Naples

Brief Summary

The purpose of this study is to describe the treatments received and outcomes of patients with metastatic colorectal cancer, what percentage of these patients have K-Ras mutation of the tumor, and to describe the costs of treatments. Information will also be collected regarding risk factors, variables among treatment centers and patients, and explorative analyses will be done to try to identify factors that impact prognosis and factors that predict tolerability and response to treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-07-24
• Study First Posted: 2012-07-26
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Histologic diagnosis colorectal carcinoma
• Metastatic disease
• Signed informed consent

Exclusion Criteria

• Prior treatment of metastatic colorectal cancer
• Refusal or incapability of providing informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with K-Ras mutation	2 years
percentage of patients enrolled in a clinical trial	two years
percentage of patients who undergo K-Ras mutation study	2 years

Trial Locations

Locations (4)

Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico; 🇮🇹 Napoli, Italy

A.O.G. Rummo; 🇮🇹 Benevento, Italy

Ospedale Civile Umberto I; 🇮🇹 Nocera Inferiore, Italy

C:R.O. Regione Basilicata Ospedale Giustino Fortunato; 🇮🇹 Rionero in Vulture, Italy