Randomized Trial Comparing Fecal Testing (FIT) to Colonoscopy for Post-polypectomy Surveillance

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorSorlandet Hospital HF

About this trial

From observational studies, it is know that the risk of developing colorectal cancer after polyp removal is lower if the patients adheres to surveillance recommendations. However, colonoscopy is burdensome for patients and colonoscopy availability is limited in many parts of the world. In addition, more than half of surveillance colonoscopies are without any findings. The trial investigates whether surveillance using fecal testing for blod is as good as colonoscopy after removal of colorectal polyps.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

High-quality baseline colonoscopy with adequat cleansing and cecal intubation

Remocval of at least one advanced adenoma

Clean colon (all polyps removed)

Signed informed consent

Disqualifiers

Colorectal cancer

History of surgical colon resection for any reason

Genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)

≥ 10 adenomas at baseline colonoscopy (cumulative)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fecal occult blood testing

    Diagnostic test

    Fecal testing for blood as surveillance efter polyp removal

  • Colonoscopy

    Diagnostic test

    Colonoscopy after polyp removal according to guidelines

Treatment groups

4,000 Participants
are divided into 2 treatment groups
Group A: ColonoscopyActive comparator 1 intervention
Group B: Fecal blood testingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Colorectal cancer incidence

Time frame
12 years from randomization

Secondary outcomes

1

Colorctal cancer mortality

Time frame
12 years from randomization
2

Advanced neoplasia incidence

Findings of colorectal cancer and high-risk polyps

Time frame
3 years from randomization
3

Findings at colonoscopy

Pathology detected during colonoscopy in both arms

Time frame
12 years from randomization
4

Colonoscopy utilization

Number of colonoscopies performed

Time frame
12 years after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sorlandet Hospital HF

Lead sponsor

Sykehuset Ostfold

Collaborator

University Hospital, Akershus

Collaborator

Vestre Viken Hospital Trust

Collaborator

Sykehuset Telemark Hospital Trust

Collaborator

Helse Møre og Romsdal HF

Collaborator

St. Olavs Hospital

Collaborator

University Hospital of North Norway

Collaborator

Sykehuset i Vestfold HF

Collaborator

Helse Stavanger HF

Collaborator

Turku University Hospital

Collaborator

Helsinki University Central Hospital

Collaborator

Randers Regional Hospital

Collaborator

Viborg Regional Hospital

Collaborator

Gødstrup Hospital

Collaborator

Horsens Hospital

Collaborator