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Participation and Detection Rate of Screening CT Colonography and Screening Sigmoidoscopy (Proteus)

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: NCT01739608
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : January 31, 2020
Sponsor:
Collaborators:
im3D S.p.A.
Regione Piemonte
Candiolo Cancer Institute - IRCCS
Information provided by (Responsible Party):
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Cancer Other: Invitation to screening Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40945 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : December 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2018

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Detection rate for cancer and advanced adenoma of CT Colonography versus FS in an invitational CRC screening program [ Time Frame: three years ]
    Proportion of subjects detected with CRC or advanced adenomas out of those examined

  2. Participation rate to FS and CT Colonography [ Time Frame: one year ]
    Proportion of subjects attending the proposed examination out of those invited


Secondary Outcome Measures :
  1. Number of participants with severe adverse events in both screening groups [ Time Frame: three years ]
    Absolute number of events

  2. Costs of a CRC screening based on CTC [ Time Frame: three years ]
    Unit cost of each procedures for participants

  3. Type of false positive detections of Computer-aided detection for CTC in a CRC screening program [ Time Frame: three years ]
    Characteristics of false positive subjects



Information from the National Library of Medicine

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Ages Eligible for Study:   58 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

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): NCT01739608


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
ClinicalTrials.gov Identifier: NCT01739608    
Other Study ID Numbers: 14334-c27.2
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Keywords provided by Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte:
CRC
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