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
Secondary identifying numbers 460
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Morena Malaspina
Scientific

via Gaetano Donizetti 75
Perugia
06132
Italy

Phone 3285811564
Email morena.malaspina@uslumbria1.it
Dr Basilio Ubaldo Passamonti
Scientific

via Pietro Mascagni 31/B
Perugia
06132
Italy

Phone 3482504598
Email basilio.passamonti@uslumbria1.it

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study design
Study setting(s)Community
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAssessing 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 objectivesThe 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) studiedColorectal cancer
InterventionDuring 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureParticipation rate, measured at 6 months since the invitation, as the proportion of those performing the test of those invited
Secondary outcome measures1. 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
Overall study start date01/02/2014
Completion date31/12/2015

Eligibility

Participant type(s)All
Age groupAdult
SexBoth
Target number of participants48,878 Participants
Key inclusion criteria1. Men and women
2. Age ranged 50-74 years
3. Resident in Umbria Region
4. Without personal history of colorectal cancer
Key exclusion criteria1. 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 enrolment06/11/2014
Date of final enrolment31/03/2015

Locations

Countries of recruitment

  • Italy

Study participating centre

Screening Laboratory, Umbria Region (Laboratorio Unico di Screening Regione Umbria)
Via XIV settembre 75
Perugia
06124
Italy

Sponsor information

Umbria Region: Prevention, veterinary and food safety
Government

via Mario Angeloni 61
Perugia
06124
Italy

Phone 0755045235
Email mdgiaimo@regione.umbria.it

Funders

Funder type

Industry

A Menarini Diagnostics (Italy)

No information available

Kyjowa Medex Co.,Ltd (Japan)

No information available

Results and Publications

Intention to publish date31/10/2016
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planWe are preparing a report reporting comparative data on diagnostic accuracy
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2018 Yes No

Editorial Notes

19/03/2018: Publication reference added.