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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01651013
Recruitment Status : Unknown
Verified November 2015 by National Cancer Institute, Naples.
Recruitment status was:  Recruiting
First Posted : July 26, 2012
Last Update Posted : November 26, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

Study Description
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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.

Condition or disease
Metastatic Colorectal Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicentered Observational Prospective Cohort Study on the Treatment of Metastatic Colorectal Cancer and the Role of Evaluating K-Ras
Study Start Date : October 2010
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

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Groups and Cohorts
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Group/Cohort
metastatic colorectal cancer


Outcome Measures
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Primary Outcome Measures :
  1. percentage of patients enrolled in a clinical trial [ Time Frame: two years ]
  2. percentage of patients who undergo K-Ras mutation study [ Time Frame: 2 years ]
  3. Percentage of patients with K-Ras mutation [ Time Frame: 2 years ]

Other Outcome Measures:
  1. metastatic colorectal cancer treatments used in clinical practice, according to participating center [ Time Frame: 2 years ]
  2. patient outcome according to K-Ras status [ Time Frame: two years ]
  3. estimated costs per treatment per center [ Time Frame: 2 years ]
  4. disease outcome per patient per treatment received [ Time Frame: 2 years ]
  5. factors that influence patient prognosis [ Time Frame: 2 years ]
    exploratory analyses

  6. predictive factors for response to treatment [ Time Frame: 5 years ]
    exploratory analyses


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients at participating Institutes who are candidate for first-line treatment of metastatic colorectal cancer
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651013


Contacts
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Contact: Francesco Perrone, M.D., Ph.D. +39 081 5903571 francesco.perrone@usc-intnapoli.net
Contact: Marilina Piccirillo, M.D. +39 081 5903383 marilina.piccirillo@usc-intnapoli.net

Locations
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Italy
A.O.G. Rummo Recruiting
Benevento, Italy
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico Recruiting
Napoli, Italy
Ospedale Civile Umberto I Recruiting
Nocera Inferiore, Italy
C:R.O. Regione Basilicata Ospedale Giustino Fortunato Recruiting
Rionero in Vulture, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
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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
More Information
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Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01651013    
Other Study ID Numbers: CALLAS
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases