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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 40945
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Piedmont
    • Torino, Piedmont, Italy, 10123
      • S.C.D.O. Epidemiologia dei Tumori - Azienda Ospedaliera S. Giovanni Battista di Torino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate for cancer and advanced adenoma of CT Colonography versus FS in an invitational CRC screening program	Proportion of subjects detected with CRC or advanced adenomas out of those examined	three years
Participation rate to FS and CT Colonography	Proportion of subjects attending the proposed examination out of those invited	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with severe adverse events in both screening groups	Absolute number of events	three years
Costs of a CRC screening based on CTC	Unit cost of each procedures for participants	three years
Type of false positive detections of Computer-aided detection for CTC in a CRC screening program	Characteristics of false positive subjects	three years

Collaborators and Investigators

• Sponsor: Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
• Collaborators: im3D S.p.A.; Regione Piemonte; Candiolo Cancer Institute - IRCCS
• Investigators: Principal Investigator: Daniele Regge, MD, Institute for Cancer Research and Treatment at Candiolo

Publications and helpful links

General Publications

• Regge D, Iussich G, Segnan N, Correale L, Hassan C, Arrigoni A, Asnaghi R, Bestagini P, Bulighin G, Cassinis MC, Ederle A, Ferraris A, Galatola G, Gallo T, Gandini G, Garretti L, Martina MC, Molinar D, Montemezzi S, Morra L, Motton M, Occhipinti P, Pinali L, Soardi GA, Senore C. Comparing CT colonography and flexible sigmoidoscopy: a randomised trial within a population-based screening programme. Gut. 2017 Aug;66(8):1434-1440. doi: 10.1136/gutjnl-2015-311278. Epub 2016 Apr 12.
• Regge D, Iussich G, Senore C, Correale L, Hassan C, Bert A, Montemezzi S, Segnan N. Population screening for colorectal cancer by flexible sigmoidoscopy or CT colonography: study protocol for a multicenter randomized trial. Trials. 2014 Mar 28;15:97. doi: 10.1186/1745-6215-15-97.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: May 23, 2012
• First Submitted That Met QC Criteria: November 29, 2012
• First Posted (Estimate): December 3, 2012

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: CRC
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 14334-c27.2