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Clinical Trials in Denmark / NCT06040632
Active, not recruiting Observational

IMPROVE-pT1: Accurate Allocation of Completion Resection in Early Colorectal Cancer

NCT06040632 · tracked via the Priya Life Science Denmark tracker
Sponsor
University of Aarhus
Phase
Observational
Started
2022-09-01
Last updated
2026-04-29

Condition(s) studied

Colorectal CancerColorectal PolypColorectal Cancer Stage I

Study summary

After introducing a nationwide screening program for colorectal cancer (CRC) in Denmark, more cases of early-stage CRC are being detected. Cancers in the earliest stages are often removed locally, either during the diagnostic colonoscopy or through planned minimally invasive surgery.

This early detection of cancer, and thereby an improved prognosis, is a positive feature but has also introduced a new clinical dilemma. Is the patient fully cured by the local resection, or do they need further surgery? Whether further surgery is recommended at the Multi-Disciplinary Team (MDT) board meeting depends on the outcome of specific criteria from the histopathological assessment of the locally removed specimen.

The presence of these criteria does not, however, translate directly into the presence of residual disease - merely into a theoretically increased risk. In Denmark, after surgery, the fraction of cases with residual disease has been around 15% for many years. In the remaining 85% of cases, local removal alone was curative - and the surgery appears excessive.

Investigating blood samples for the presence of circulating tumor DNA (ctDNA) is a new and promising method for cancer detection. The method utilizes that cancer cells release ctDNA into the circulation. ctDNA detected in blood drawn from a patient a few days after local removal of a tumor indicates that residual disease is present and further treatment, such as surgery, is needed.

The purpose of this study is to investigate, whether analyses of ctDNA can correctly identify patients with residual disease after local removal of early CRC. If this identification proves accurate, many patients can be spared further surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients having undergone local resection of pT1 colorectal cancer and with planned completion resection, as recommended by the local MDT board * The reason for the planning of completion resection may be non-micro radical tumor removal, piece-meal resection making assessment of resection margin impossible or the presence of one or more histological risk factors Exclusion Criteria: * Patients not able to understand information about the study and/or give informed consent * Patients not accepting blood samples stored in biobank * Cases with non-obtainable primary tumor tissue, required for the conduction of mutational analyses * Other recent (within 5 years) or current malignant disease, except basocellular carcinoma of the skin * Planned completion resection due to other factors, such as patient's wish or hereditary disposition for CRC, and with the absence of risk factors mentioned above * Withdrawal of consent

Primary outcome measure(s)

  • ctDNA analysis — After recruitment of the last patient, we expect that ctDNA analyses can be performed within 6 months
    Blood samples will be categorized as either ctDNA positive or negative

Trial sites (9)

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

More University of Aarhus trials in Denmark

The Role of Radiotherapy for the Management of Non-melanoma Skin Cancer in Denmark. Enrolling by invitation
Endometriosis, Food Consumption and Fertility Recruiting
Perioperative Treatment With Tranexamic Acid in Melanoma Recruiting
Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage Recruiting
Infusion of Furosemide to Improve Diuretic Efficiency in Acute Heart Failure Recruiting

Other trials for the same condition

Combining Intratumoral Flu Vaccine and Systemic Pembrolizumab in Patients With Early pMMR Colorectal Cancer Starting soon
SMARTER: Using Blood Samples to iMprove FIT-bAsed coloRecTal cancEr scReening Recruiting
ctDNA-guided Surveillance for Stage III CRC, a Randomized Intervention Trial Active, not recruiting
Prospective Study of Extended Robotic Right Hemicolectomy With Complete Mesocolic Excision for Cancer Recruiting
Low Versus Standard Intraabdominal Pressure in Robot-assisted Colorectal Cancer Surgery Recruiting
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 NCT06040632 on ClinicalTrials.gov ↗ ← All trials in Denmark