Participation and Detection Rate of Screening CT Colonography and Screening Sigmoidoscopy

Colorectal Cancer Clinical Trial

— Proteus  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739608
• Other study ID #: 14334-c27.2
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2018

Study information

• Verified date: January 2020
• Source: Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40945
• Est. completion date: December 2018
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 58 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Invitation to screening
Invitation to screening

Locations

Country	Name	City	State
Italy	S.C.D.O. Epidemiologia dei Tumori - Azienda Ospedaliera S. Giovanni Battista di Torino	Torino	Piedmont

Sponsors (4)

Lead Sponsor	Collaborator
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte	Candiolo Cancer Institute - IRCCS, im3D S.p.A., Regione Piemonte

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Participation rate to FS and CT Colonography	Proportion of subjects attending the proposed examination out of those invited	one year
Secondary	Number of participants with severe adverse events in both screening groups	Absolute number of events	three years
Secondary	Costs of a CRC screening based on CTC	Unit cost of each procedures for participants	three years
Secondary	Type of false positive detections of Computer-aided detection for CTC in a CRC screening program	Characteristics of false positive subjects	three years