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

NCT06040632 | Active Not Recruiting

• 1 other identifier: IMPROVE-pT1
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Colorectal Cancer; Colorectal Polyp; Colorectal Cancer Stage I

Outcome Measures

Primary Outcomes (1)

• ctDNA analysis

  Blood samples will be categorized as either ctDNA positive or negative

  After recruitment of the last patient, we expect that ctDNA analyses can be performed within 6 months

Secondary Outcomes (3)

• Pathological evaluation of the resected specimen from the completion resection

  After recruitment of the last patient, these data will be available (expected in spring 2024)

• 30- and 90-day mortality related to the completion resection

  These data will be extracted from the patient's medical records 3 months after surgery

• Postoperative morbidities

  After recruitment of the last patient, these data will be extracted from the patient's medical records within 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients having undergone local resection of pT1 colorectal cancer and with planned completion resection, as recommended by the local MDT board

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Copenhagen University Hospital at Herlev: collaborator
• Regionshospitalet Horsens: collaborator
• Aarhus University Hospital: collaborator
• Regional Hospital Randers: collaborator

Study Sites (9)

Bispebjerg Hospital

Copenhagen, Capital Region of Denmark, 2400, Denmark

Location

Herlev Hospital

Herlev, Capital Region of Denmark, 2730, Denmark

Location

Aarhus University Hospital

Aarhus, Central Jutland, 8000, Denmark

Location

Gødstrup Hospital

Herning, Central Jutland, 7400, Denmark

Location

Regional Hospital Horsens

Horsens, Central Jutland, 8700, Denmark

Location

Regional Hospital Randers

Randers, Central Jutland, 8930, Denmark

Location

Regional Hospital Viborg

Viborg, Central Jutland, 8800, Denmark

Location

Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

Location

Odense University Hospital

Odense, The Region of Southern Denmark, 5000, Denmark

Location

Related Publications (1)

• Zviran A, Schulman RC, Shah M, Hill STK, Deochand S, Khamnei CC, Maloney D, Patel K, Liao W, Widman AJ, Wong P, Callahan MK, Ha G, Reed S, Rotem D, Frederick D, Sharova T, Miao B, Kim T, Gydush G, Rhoades J, Huang KY, Omans ND, Bolan PO, Lipsky AH, Ang C, Malbari M, Spinelli CF, Kazancioglu S, Runnels AM, Fennessey S, Stolte C, Gaiti F, Inghirami GG, Adalsteinsson V, Houck-Loomis B, Ishii J, Wolchok JD, Boland G, Robine N, Altorki NK, Landau DA. Genome-wide cell-free DNA mutational integration enables ultra-sensitive cancer monitoring. Nat Med. 2020 Jul;26(7):1114-1124. doi: 10.1038/s41591-020-0915-3. Epub 2020 Jun 1.

  PMID: 32483360 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be drawn prior to and around 14 days after completion resection. Blood draw: 80 mL - 7 x EDTA tubes, 1 x serum tube Formalin-fixed paraffin-embedded (FFPE) tissue from the local treatment will be obtained from the relevant Pathological departments, for the purpose of extracting DNA for mutational analysis.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Mads F Klein, MD, PhD

  Copenhagen University Hospital at Herlev

  PRINCIPAL INVESTIGATOR

• Jeppe Kildsig, MD

  Copenhagen University Hospital at Herlev

  PRINCIPAL INVESTIGATOR

• Kåre A Gotschalck, MD, PhD

  Regionshospitalet Horsens

  PRINCIPAL INVESTIGATOR

• Anne-Sofie Kannerup, MD, PhD

  Regional Hospital Randers

  PRINCIPAL INVESTIGATOR

• Lene H Iversen, MD, DMSc

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 15, 2023
• Study Start: September 1, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

DK (9)