Participation and Detection Rate Diagnostic of a Colorectal Cancer Screening Program: CT Colonography vs. Flexible Sigmoidoscopy (Proteus)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Sponsor:
Collaborators:
im3D S.p.A.
Regione Piemonte
Institute for Cancer Research and Treatment, Candiolo, Italy
Information provided by (Responsible Party):
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
ClinicalTrials.gov Identifier:
NCT01739608
First received: May 23, 2012
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

The objectives of this multicenter, randomized trial is to assess the participation rate achievable through two different screening strategies (Computed Tomographic Colonography-CTC and sigmoidoscopy-FS), to compare detection rate of colorectal cancer (CRC) and advanced adenoma of tests and to evaluate their costs. The role of Computer-aided detection (CAD) for CTC screening will be also assessed. The trial involves 10 Italian centers located in the Piedmont Region and in Verona. Residents aged 58-60 years in those districts are target for recruitment. Exclusion criteria include: previous diagnosis of cancer or adenoma; family history or hereditary syndromes; personal history of inflammatory bowel disease; patients screened by colonoscopy or FOBT within 2 years; severe disease.


Condition Intervention Phase
Colorectal Cancer
Other: Invitation to screening
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Assessment of the Participation Rate and the Diagnostic Accuracy of a Colorectal Cancer Screening Program: CT Colonography Versus Flexible Sigmoidoscopy. Evaluation of a New Model Based on Telediagnosis

Resource links provided by NLM:


Further study details as provided by Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte:

Primary Outcome Measures:
  • Detection rate for cancer and advanced adenoma of CT Colonography versus FS in an invitational CRC screening program [ Time Frame: three years ] [ Designated as safety issue: No ]
  • Participation rate to FS and CT Colonography [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with severe adverse events in both screening groups [ Time Frame: three years ] [ Designated as safety issue: Yes ]
  • Costs of a CRC screening based on CTC [ Time Frame: three years ] [ Designated as safety issue: No ]
  • Type of false positive detections of Computer-aided detection for CTC in a CRC screening program [ Time Frame: three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20000
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CT Colonography (CTC)
Invitation to screening. Subject who consent to participate in the study undergo to low dose CTC examination with limited bowel preparation.
Other: Invitation to screening
Invitation to screening
Active Comparator: Sigmoidoscopy (FS)
Invitation to screening. Subjects who consent to participate in the study undergo to FS.
Other: Invitation to screening
Invitation to screening

Detailed Description:

Design:

  • To compare detection of advanced neoplasia of CT colonography (CTC) to sigmoidoscopy (FS), a total of 20.000 eligible individuals living in the target areas are mailed an invitation letter to participate in the trial. All invitees are asked to call the screening centre in order to receive detailed information about study protocol, the screening examinations and the bowel preparation. Responders who consent to participate in the study are randomly assigned to undergo screening with CTC or FS. All non-responders will be invited to Fecal Occult Blood test (FOBT) according to the current screening procedure. In the CTC arm, positive patients (containing at least one polyp 6 mm or larger) are referred to colonoscopy; negative patients (no polyps >5 mm) are scheduled to be invited to have an FOBT after two years. In the FS arm, positive patients (at least one advanced adenoma found during FS examination) are referred to colonoscopy; negative patients are offered no further follow-up.
  • To compare participation rate to FS and CTC, 1200 individuals living in the target areas and never screened for colorectal cancer, are randomly assigned to receive an invitation for screening with CTC or FS. Individuals of both groups will receive an invitation letter and an information leaflet, containing information about colorectal cancer, importance of screening, and advantages and possible risks of the selected test. Invitation letter for CTC contains a phone number of the screening centre. All invitees are asked to call the screening centre in order to receive information about bowel preparation. All non-responders will receive a remainder by mail after one month. Non-responders to reminder will be invited to FS according with current screening procedure. In the CTC arm, positive patients (containing at least one polyp 6 mm or larger) are referred to colonoscopy; negative patients (no polyps >5 mm) are scheduled to be invited to have an FOBT after two years. In the FS arm, positive patients (at least one advanced adenoma found during FS examination) are referred to colonoscopy; negative patients are offered no further follow-up.
  Eligibility

Ages Eligible for Study:   58 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asymptomatic individuals, at average risk for CRC, 58-60 years old.

Exclusion Criteria:

  • Personal history of CRC or polyps
  • Family history of CRC or polyps
  • A terminal illness or inflammatory bowel disease
  • Previous five years complete colonoscopy or a FOBT within the previous 2 years
  • Patients who are unable to give 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 ClinicalTrials.gov identifier: NCT01739608

Contacts
Contact: Carlo Senore, MD +390116333890 carlo.senore@cpo.it

Locations
Italy
S.C.D.O. Epidemiologia dei Tumori - Azienda Ospedaliera S. Giovanni Battista di Torino Recruiting
Torino, Piedmont, Italy, 10123
Sponsors and Collaborators
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
im3D S.p.A.
Regione Piemonte
Institute for Cancer Research and Treatment, Candiolo, Italy
Investigators
Principal Investigator: Daniele Regge, MD Institute for Cancer Research and Treatment at Candiolo
  More Information

No publications provided by Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
ClinicalTrials.gov Identifier: NCT01739608     History of Changes
Other Study ID Numbers: 14334-c27.2
Study First Received: May 23, 2012
Last Updated: November 29, 2012
Health Authority: Italy: National Institute of Health

Keywords provided by Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte:
CRC

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

ClinicalTrials.gov processed this record on October 01, 2014