Observational Study on Treatment of Metastatic Colorectal Cancer and the Role of K-Ras
CALLAS
Multicentered Observational Prospective Cohort Study on the Treatment of Metastatic Colorectal Cancer and the Role of Evaluating K-Ras
1 other identifier
observational
500
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2010
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 24, 2012
CompletedFirst Posted
Study publicly available on registry
July 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMarch 24, 2023
March 1, 2023
13.2 years
July 24, 2012
March 23, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
percentage of patients enrolled in a clinical trial
two years
percentage of patients who undergo K-Ras mutation study
2 years
Percentage of patients with K-Ras mutation
2 years
Other Outcomes (6)
metastatic colorectal cancer treatments used in clinical practice, according to participating center
2 years
patient outcome according to K-Ras status
two years
estimated costs per treatment per center
2 years
- +3 more other outcomes
Study Arms (1)
metastatic colorectal cancer
Eligibility Criteria
Patients at participating Institutes who are candidate for first-line treatment of metastatic colorectal cancer
You may qualify if:
- Histologic diagnosis colorectal carcinoma
- Metastatic disease
- Signed informed consent
You may not qualify if:
- Prior treatment of metastatic colorectal cancer
- Refusal or incapability of providing informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
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, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
R. V. Iaffaioli, M.D.
National Cancer Institute, Naples
- PRINCIPAL INVESTIGATOR
G. Nasti, M.D.
National Cancer Institute, Naples
- PRINCIPAL INVESTIGATOR
M. C. Piccirillo, M.D.
National Cancer Institute, Naples
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2012
First Posted
July 26, 2012
Study Start
October 1, 2010
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
March 24, 2023
Record last verified: 2023-03