Assessing the impact of a new fit test in the context of a population based organized screening programme for colorectal cancer
| ISRCTN | ISRCTN20086618 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20086618 |
| Protocol serial number | 460 |
| Sponsor | Umbria Region: Prevention, veterinary and food safety |
| Funders | A Menarini Diagnostics (Italy), Kyjowa Medex Co.,Ltd (Japan) |
- Submission date
- 03/05/2016
- Registration date
- 17/05/2016
- Last edited
- 19/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Colorectal, or bowel cancer, is very common. However, if detected at an early stage, it can be easier to treat and led to a much better chance of survival. The fecal immunochemical test (FIT) is a screening test for bowel cancer that tests for hidden blood in the stool. Blood in the stool can be an early sign of the disease. This study is investigating a new FIT screening test called FIT HM-Jackarc. It compares how this test performs against the test that is in routine use (FIT OC-Sensor Diana).
Who can participate?
Adults aged between 50-75.
What does the study involve?
Participants are randomly allocated to one of two groups. One group is screened for colorectal cancer using FIT HM-Jackarc. The other group is screened for colorectal cancer using FIT OC-Sensor Diana.
All participants from both groups receive an invitation kit though the post. This includes a consent form for them to sign and a leaflet describing the study. They are asked to store their stool sample at
4°C and send it back to the laboratory using the pre-paid envelope provided. The analyses are performed by experienced laboratory medicine professionals. Participants found to have hidden blood in their stool undergo a colonoscopy (a procedure where a camera is used to look at the inside of the bowel).
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Screening Laboratory, Umbria Region, Perugia (Italy)
When is the study starting and how long is it expected to run for?
February 2014 to December 2015
Who is funding the study?
1. A Menarini Diagnostics (Italy)
2. Kyjowa Medex Co.,Ltd (Japan)
Who is the main contact?
1. Dr Morena Malaspina (scientific)
morena.malaspina@uslumbria1.it
2. Dr Basilio Ubaldo Passamonti (scientific)
basilio.passamonti@uslumbria1.it
Contact information
Scientific
via Gaetano Donizetti 75
Perugia
06132
Italy
| Phone | 3285811564 |
|---|---|
| morena.malaspina@uslumbria1.it |
Scientific
via Pietro Mascagni 31/B
Perugia
06132
Italy
| Phone | 3482504598 |
|---|---|
| basilio.passamonti@uslumbria1.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | |
| Study type | Participant information sheet |
| 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 |
| Study objectives | The aim of this study is to compare the performances of two fecal immunochemical tests |
| Ethics approval(s) | Ethics Committee Healthcare Company, 29/04/2014, ref: 3032/14/AV Registration n. 2289/14 |
| Health condition(s) or problem(s) studied | Colorectal cancer |
| Intervention | 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%. Cancer was defined as the invasion of malignant cells beyond the muscularis mucosae. |
| Intervention type | Device |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Participation rate, measured at 6 months since the invitation, as the proportion of those performing the test of those invited |
| Key secondary outcome measure(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 |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 48878 |
| Key inclusion criteria | 1. Men and women 2. Age ranged 50-74 years 3. Resident in Umbria Region 4. Without personal history of colorectal cancer |
| Key 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 |
| Date of first enrolment | 06/11/2014 |
| Date of final enrolment | 31/03/2015 |
Locations
Countries of recruitment
- Italy
Study participating centre
Perugia
06124
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2018 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/03/2018: Publication reference added.
