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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Cancer Institute, Naples
Information provided by (Responsible Party):
National Cancer Institute, Naples Identifier:
First received: July 24, 2012
Last updated: January 3, 2014
Last verified: January 2014

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:

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)
rectal cancer


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.


Inclusion Criteria:

  • Histologic diagnosis rectal carcinoma
  • Signed informed consent

Exclusion Criteria:

  • Refusal or incapability of providing informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01651026

Contact: Francesco Perrone, M.D., Ph.D. +39 081 5903571
Contact: Marilina Piccirillo, M.D. +39 081 5903383

A.O.R.N. V. Monaldi Recruiting
Napoli, Italy
A.O.U. Federico II Recruiting
Napoli, Italy
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico Recruiting
Napoli, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
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 Identifier: NCT01651026     History of Changes
Other Study ID Numbers: CROSS-1
Study First Received: July 24, 2012
Last Updated: January 3, 2014
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases processed this record on November 27, 2014