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

This study is currently recruiting participants.
Verified July 2017 by National Cancer Institute, Naples
Sponsor:
ClinicalTrials.gov Identifier:
NCT01651026
First Posted: July 26, 2012
Last Update Posted: July 17, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute, Naples
  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
Metastatic Colorectal Cancer

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

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 ]

Other Outcome Measures:
  • all treatments received for colorectal cancer (surgery, radiation therapy, chemotherapy, supportive care, etc) per patient [ Time Frame: 5 years ]
  • rectal cancer surgical interventions/approaches per participating center [ Time Frame: 5 years ]
  • disease outcomes per patient per treatment received [ Time Frame: 5 years ]
  • estimated costs per treatment pattern per center [ Time Frame: 5 years ]
  • factors that influence patient prognosis [ Time Frame: 5 years ]
    exploratory analyses

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


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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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
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
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

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01651026     History of Changes
Other Study ID Numbers: CROSS-1
First Submitted: July 24, 2012
First Posted: July 26, 2012
Last Update Posted: July 17, 2017
Last Verified: July 2017

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