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NCT06940947RecruitingPhase 3

Endoscopic Therapy Or Surgery for Early Colon Cancer

Endoscopic THerapy Or Surgery for Early Colon Cancer (ETHOS)

Source: ClinicalTrials.gov · Last updated 20 Nov 2025

Brief summary (registry, in English)

The trial is a randomized head-to-head comparison of the benefits, harms and burdens of endoscopic full-thickness resection (eFTR), a novel, minimally invasive endoscopic treatment modality, for early colon cancer as compared to standard-of-care surgery.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
434 (estimated)
First submitted
15 Apr 2025
Start date
25 Aug 2025
Primary completion date
1 Sept 2033
Lead sponsor
Norwegian Department of Health and Social Affairs
NCT number
NCT06940947

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 434
  • From 25 Aug 2025 to the primary completion date, 1 Sept 2033
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • Newly diagnosed biopsy-confirmed colon cancer (adenocarcinoma) with macroscopic suspicion of submucosal invasion considered removable by EFTR as deemed by the local multidisciplinary team (MDT) at the participating center
  • Size ≤20 mm in diameter as deemed by the colonoscopist
  • No presence of histopathological high-risk features in biopsy (high grade tumor growth, budding grade 2 or 3, or lymphovascular invasion)
  • Patient eligible for surgical removal as deemed by the local MDT at the participating center
  • Endoscopic images or video of the tumor
  • No sign of disease beyond T2N0M0 on pre-treatment imaging, biopsy sampling, and radiographic and clinical evaluation
  • No contraindication for any of the two treatment arms
  • Written informed consent
  • No prior or synchronous CRC
  • No other malignancy which is not cured
  • No more than 10 adenomas or serrated polyps
  • No genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
  • No inflammatory bowel disease

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University Of Gdansk
Coordinator of this site? Confirm its status
GdanskPolandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.