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Clinical Trials in Denmark / NCT04084249
Active, not recruiting Not applicable

ctDNA-guided Surveillance for Stage III CRC, a Randomized Intervention Trial

NCT04084249 · tracked via the Priya Life Science Denmark tracker
Sponsor
Claus Lindbjerg Andersen
Phase
Not applicable
Started
2020-01-01
Last updated
2026-04-29

Condition(s) studied

Colorectal CancerColo-rectal CancerctDNAGastro-Intestinal DisorderColorectal NeoplasmsGastrointestinal CancerGastrointestinal NeoplasmsDigestive System DiseaseDigestive System NeoplasmColonic DiseasesColonic NeoplasmsColonic CancerRectal DiseasesRectal NeoplasmsRectal Cancer

Investigational drug(s) / intervention(s)

ctDNA-analysisIntensified Follow-up Schedule

ctDNA-analysis: Minimally-invasive blood-based analysis of circulating tumor DNA (ctDNA).

Intensified Follow-up Schedule: PET/CT-scans every 3. month

Study summary

IMPROVE-IT2 is a randomized multicenter trial comparing the outcomes of ctDNA guided post-operative surveillance and standard-of-care CT-scan surveillance. The hypothesis of this study is that ctDNA guided post-operative surveillance combining ctDNA and radiological assessments could result in earlier detection of recurrent disease and identify more patients eligible for curative treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Colon or rectal cancer, tumor stage III (pT1-4N1-2,cM0) or stage II high-risk (pT4N0,cM0 and pT3N0, cM0 with risk factors) * Have received curative intend resection and be candidates for adjuvant chemotherapy Exclusion Criteria: * Not treated with adjuvant chemotherapy * Synchronous colorectal and non-colorectal cancer diagnosed per-operative (except skin cancer other than melanoma) * Other cancers (excluding colorectal cancer or skin cancer other than melanoma) within 3 years from screening * Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.

Primary outcome measure(s)

  • FCI — 5 years
    Fraction of patients with relapse receiving intended curative resection or local treatment aiming at complete tumor destruction as defined at the relevant MDT conference.

Trial sites (10)

FacilityCityRegionStatus
Herlev Hospital Herlev Capital Region of Denmark
Gødstrup Hospital Herning Central Jutland
Regional Hospital Horsens Horsens Central Jutland
Regional Hospital Randers Randers Central Jutland
Aalborg University Hospital Aalborg North Denmark
Odense University Hospital Odense The Region of Southern Denmark
Aarhus University Hospital Aarhus Denmark
Bispebjerg Hospital Copenhagen Denmark
Zealand University Hospital Køge Denmark
Regional Hospital Viborg Viborg Denmark

More Claus Lindbjerg Andersen trials in Denmark

GUIDE.MRD-01-CRC: Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Colorectal Cancer Recruiting

Other trials for the same condition

Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients Recruiting
IMPROVE: Circulating Tumor DNA Analysis to Optimize Treatment for Patients With Colorectal Cancer Active, not recruiting
Adjuvant Low Dose Aspirin in Colorectal Cancer Active, not recruiting
Colorectal Omics and OfCS Proteoglycans Recruiting
Examination of Rectal Blood Supply During Rectal Cancer Surgery Using Laser Speckle Contrast Imaging Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04084249 on ClinicalTrials.gov ↗ ← All trials in Denmark