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Clinical Trials in Denmark / NCT03637686
Active, not recruiting Observational

IMPROVE: Circulating Tumor DNA Analysis to Optimize Treatment for Patients With Colorectal Cancer

NCT03637686 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2018-06-14
Last updated
2026-05-04

Condition(s) studied

Colorectal Cancer

Study summary

The overall objective of these studies are to confirm that ctDNA detected in plasma after intended curative treatment for CRC can be applied in clinical practice as a marker of subclinical residual disease and risk of recurrence.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Part I: Surgery Inclusion Criteria: * Colon or rectal cancer, clinical tumor stage I-III * Patient able to understand and sign written informed consent * Scheduled for curative intended resectional surgery Exclusion Criteria: * Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome * Inflammatory bowel disease (Crohn's disease or ulcerative colitis) * Verified distant metastases * Malignant colorectal polyps diagnosed after polypectomy * 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 Part II: Surveillance: Inclusion criteria: One of the following: * TNM stage III CRC, * or TNM stage II CRC and risk factors qualifying for adjuvant chemotherapy, * or TNM stage I or stage II CRC without risk factors, but ctDNA positive in the post-operative day14 plasma sample. Inclusion requires that the patient declined participation in the IMPROVE IT trial. Exclusion criteria: * 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

Primary outcome measure(s)

Trial sites (10)

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

More University of Aarhus trials in Denmark

Other trials for the same condition

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 NCT03637686 on ClinicalTrials.gov ↗ ← All trials in Denmark