Assessing the impact of a new fit test in the context of a population based organized screening programme for colorectal cancer

• Register: ISRCTN
• Last refreshed on: 30 April 2018
• Main ID: ISRCTN20086618
• Date of registration: 17/05/2016
• Prospective Registration: No
• Primary sponsor: Umbria Region: Prevention, veterinary and food safety
• Public title: Assessing the impact of a new fit test in the context of a population based organized screening programme for colorectal cancer
• Scientific title: Assessing the impact of a new fit test in the context of a population based organized screening programme for colorectal cancer: a comparative effectiveness trial
• Date of first enrolment: 06/11/2014
• Target sample size: 48878
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN20086618
• Study type: Interventional
• Study design: Randomised controlled trial (Screening)

Countries of recruitment

Italy

Contacts

• Name: Morena Malaspina

Key inclusion & exclusion criteria

Inclusion criteria: 1. Men and women
2. Age ranged 50-74 years
3. Resident in Umbria Region
4. Without personal history of colorectal cancer
Exclusion criteria: 1. Personal history of colorectal cancer
2. Participants undergone tests for fecal blood within 2 years
3. Participants undergone sigmoidoscopy or colonoscopy within 5 years

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Colorectal cancer
Cancer
Colorectal cancer

Intervention(s)

During the enrolment period (from 06 November 6th, 2014 to 31 March 2015), all the eligible population were randomly allocated (ratio 1:1) to be screened with two fecal immunochemical test (FIT) systems, namely:

1. OC-Sensor
2. HM- JACKarc

The randomisation was stratified by gender, age group (50-59/60-74 years), screening history (first/subsequent screening) and area of residence (urban/rural). The scheme was computer generated within the screening programme IT system which governs the screening programmes and identifies when individuals are to be invited to participate. The process of generating and mailing the different invitation materials was fully automated, therefore blinding the researchers to the allocation of the intervention to individuals. A reminder letter was mailed to all non-responders three months following the initial invitation.

The invitation kit mailed for the study included an informed consent form and a leaflet explaining the design and the rationale for the study. The invitation materials were designed to be as similar as possible for each both of the analytical systems. Participants were instructed to store the sample at 4°C. and to send back the sample device to the central laboratory, using the pre-paid envelope included in the invitation kit, as soon as possible. Devices were collected and forwarded to the screening laboratory every 24 hours day by the mail postal company, following the routine procedures usually adopted in of the screening programme. All the exams were processed and analyses were performed in the central laboratory of the Umbria screening programme by three experienced laboratory medicine professionals. Participants with positive results from FIT (20 µg Hb/gr faeces) were underwent colonoscopy. Histology was defined according to the World Health Organization criteria. Advanced adenoma (AA) was defined as an adenoma with any of the following features: size = 10 mm, high-grade dysplasia, or villous component >20%.

Primary Outcome(s)

Participation rate, measured at 6 months since the invitation, as the proportion of those performing the test of those invited

Secondary Outcome(s)

1. Proportion of inadequate tests: measured at the end of the study, as the proportion of samples with inadequate material for the analysis. Laboratory assessment
2. Positivity rate: measured at the end of the study, as the proportion of samples with Hb level above the stipyulated cut-off value (100 ng/ml buffer) over the total number of adequate tests. Laboratory assessment
3. Positive predictive value (PPV): mesasured at the end of the study, as the proportion of subjects detected with a CRC or advanced adenoma over those ubdergoring colonscopy assessment
4. Detection rate (DR) for advanced adenoma and CRC: mesasured at the end of the study, as the proportion of subjects detected with a CRC or advanced adenoma over those who have perfromed the FIT test
5. Number needed to scope (NNScope) to detect one advanced neoplasm (AN: advanced adenoma + CRC):mesasured at the end of the study, as 1/PPV

Secondary ID(s)

460

Source(s) of Monetary Support

A Menarini Diagnostics (Italy), Kyjowa Medex Co.,Ltd (Japan)

Ethics review

Status:
Approval date:
Contact:

Ethics Committee Healthcare Company, 29/04/2014, ref: 3032/14/AV Registration n. 2289/14

Results

• Results available: Yes
• Date Completed: 31/12/2015