Participation and Detection Rate of Screening CT Colonography and Screening Sigmoidoscopy

Study Overview
=================
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.

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.

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

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Other: Invitation to screening


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 58 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT Colonography (CTC)<br>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<br>* Invitation to screening<br>|
| Active Comparator: Sigmoidoscopy (FS)<br>Invitation to screening. Subjects who consent to participate in the study undergo to FS. | Other: Invitation to screening<br>* Invitation to screening<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRC