NCT06983639

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
288mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jan 2026Jan 2050

First Submitted

Initial submission to the registry

May 6, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

January 9, 2026

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2040

Expected
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2050

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

15 years

First QC Date

May 6, 2025

Last Update Submit

January 13, 2026

Conditions

Colorectal Neoplasms

Keywords

surveillancepolyp

Outcome Measures

Primary Outcomes (1)

  • Colorectal cancer incidence

    12 years from randomization

Secondary Outcomes (9)

  • Colorctal cancer mortality

    12 years from randomization

  • Advanced neoplasia incidence

    3 years from randomization

  • Findings at colonoscopy

    12 years from randomization

  • Colonoscopy utilization

    12 years after randomization

  • Adherence

    12 years from randomization

  • +4 more secondary outcomes

Study Arms (2)

Colonoscopy

ACTIVE COMPARATOR

Colonoscopy surveillance after polyp removal

Diagnostic Test: Colonoscopy

Fecal blood testing

EXPERIMENTAL

Fecal testing as surveillance after polypectomy

Diagnostic Test: Fecal occult blood testing

Interventions

Fecal occult blood testingDIAGNOSTIC_TEST

Fecal testing for blood as surveillance efter polyp removal

Fecal blood testing
ColonoscopyDIAGNOSTIC_TEST

Colonoscopy after polyp removal according to guidelines

Colonoscopy

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • History of advanced serrated lesion, defined as SSL≥ 10mm or with dysplasia
  • Inflammatory bowel disease
  • On-going palliative care for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sørlandet sykehus HF

Arendal, Agder, 4838, Norway

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsPolyps

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Øyvind Holme

CONTACT

004738073000oyvind.holme@sshf.no

Michael Bretthauer

CONTACT

004790132480michael.bretthauer@medisin.uio.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 21, 2025

Study Start

January 9, 2026

Primary Completion (Estimated)

December 31, 2040

Study Completion (Estimated)

January 1, 2050

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)