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

Metastatic Colorectal Cancer Clinical Trial

— CALLAS  

Official title:

Multicentered Observational Prospective Cohort Study on the Treatment of Metastatic Colorectal Cancer and the Role of Evaluating K-Ras

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01651013
• Other study ID #: CALLAS
• Status: Active, not recruiting
• Start date: October 2010
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Locations

Country	Name	City	State
Italy	A.O.G. Rummo	Benevento
Italy	Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico	Napoli
Italy	Ospedale Civile Umberto I	Nocera Inferiore
Italy	C:R.O. Regione Basilicata Ospedale Giustino Fortunato	Rionero in Vulture

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	metastatic colorectal cancer treatments used in clinical practice, according to participating center		2 years
Other	patient outcome according to K-Ras status		two years
Other	estimated costs per treatment per center		2 years
Other	disease outcome per patient per treatment received		2 years
Other	factors that influence patient prognosis	exploratory analyses	2 years
Other	predictive factors for response to treatment	exploratory analyses	5 years
Primary	percentage of patients enrolled in a clinical trial		two years
Primary	percentage of patients who undergo K-Ras mutation study		2 years
Primary	Percentage of patients with K-Ras mutation		2 years