Text Size

Multicenter Cohort Prospective Study on Multidisciplinary Treatment of Rectal Cancer (CROSS-1)

This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute, Naples
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT01651026
First received: July 24, 2012
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to describe the diagnostic and treatment procedures employed for patients with rectal cancer in each participating center. Outcomes to treatment, costs of treatment will be described. Exploratory analyses will be done to identify factor that influence patient prognosis, as well as factors that predict patient response to treatment.


Condition Phase
Metastatic Colorectal Cancer
 Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicentered Observational Prospective Cohort Study on Multidisciplinary Treatment of Rectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • list of diagnostic procedures used in clinical practice, according to participating Institute [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • all treatments received for colorectal cancer (surgery, radiation therapy, chemotherapy, supportive care, etc) per patient [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • rectal cancer surgical interventions/approaches per participating center [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • disease outcomes per patient per treatment received [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • estimated costs per treatment pattern per center [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • factors that influence patient prognosis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    exploratory analyses

  • predictive factors for response to treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    exploratory analyses


Estimated Enrollment: 600
Study Start Date: January 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
rectal cancer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Consecutive patients at participating Institutes with confirmed diagnosis of colorectal cancer.

Criteria

Inclusion Criteria:

  • Histologic diagnosis rectal carcinoma
  • Signed informed consent

Exclusion Criteria:

  • Refusal or incapability of providing informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651026

Contacts
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
Italy
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico Recruiting
Napoli, Italy
A.O.U. Federico II Recruiting
Napoli, Italy
A.O.R.N. V. Monaldi Recruiting
Napoli, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
Principal Investigator: G. Romano, M.D. National Cancer Institute, Naples
Principal Investigator: C. Sassaroli, M.D. National Cancer Institute, Naples
Principal Investigator: M. C. Piccirillo, M.D. National Cancer Institute, Naples
Principal Investigator: Francesco Perrone, M.D., Ph.D National Cancer Institute, Naples
  More Information

No publications provided

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01651026     History of Changes
Other Study ID Numbers: CROSS-1
Study First Received: July 24, 2012
Last Updated: February 27, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases

ClinicalTrials.gov processed this record on May 22, 2013