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

NCT03637686 | Active Not Recruiting DMC

• 1 other identifier: IMPROVE
• Study Type: observational
• Target: 3,182
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; Circulating tumor DNA

Outcome Measures

Primary Outcomes (1)

• Patients with high risk of recurrence can be identified with ctDNA profiling performed immediately after treatment for CRC.

  3-year disease-free survival (3y-DFS)

  3 years

Secondary Outcomes (6)

• Association between ctDNA and the quality of primary surgery - the plane of the surgery

  3 years

• Association between ctDNA and the quality of primary surgery - the level of resection of the tumor feeding arteries

  1 years

• ctDNA profiling for evaluating quality improvement of surgery - before and after implementation of of a training program

  3 years

• ctDNA profiling for evaluating quality improvement of surgery - between centers with and without implementation of the training program

  3 years

• Association between ctDNA and the effect of adjuvant chemotherapy

  3 years

Eligibility Criteria

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

Study Population

All patients with stage I-III colon or rectal cancer, scheduled for curative intended resectional surgery.

You may qualify if:

• Colon or rectal cancer, clinical tumor stage I-III
• Patient able to understand and sign written informed consent
• Scheduled for curative intended resectional surgery

You may not qualify if:

• 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:
• One of the following:
• TNM stage III CRC,
• or TNM stage II CRC and risk factors qualifying for 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (10)

Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

Location

Odense University Hospital

Odense, The Region of Southern Denmark, 5000, Denmark

Location

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Regional Hospital West Jutland

Herning, 7400, Denmark

Location

Regional Hospital Horsens

Horsens, 8700, Denmark

Location

Zealand University Hospital

Køge, 4600, Denmark

Location

Regional Hospital Randers

Randers, 8930, Denmark

Location

Regional Hospital Viborg

Viborg, 8800, Denmark

Location

Related Publications (3)

• Scholer LV, Reinert T, Orntoft MW, Kassentoft CG, Arnadottir SS, Vang S, Nordentoft I, Knudsen M, Lamy P, Andreasen D, Mortensen FV, Knudsen AR, Stribolt K, Sivesgaard K, Mouritzen P, Nielsen HJ, Laurberg S, Orntoft TF, Andersen CL. Clinical Implications of Monitoring Circulating Tumor DNA in Patients with Colorectal Cancer. Clin Cancer Res. 2017 Sep 15;23(18):5437-5445. doi: 10.1158/1078-0432.CCR-17-0510. Epub 2017 Jun 9.

  PMID: 28600478 BACKGROUND

• Reinert T, Scholer LV, Thomsen R, Tobiasen H, Vang S, Nordentoft I, Lamy P, Kannerup AS, Mortensen FV, Stribolt K, Hamilton-Dutoit S, Nielsen HJ, Laurberg S, Pallisgaard N, Pedersen JS, Orntoft TF, Andersen CL. Analysis of circulating tumour DNA to monitor disease burden following colorectal cancer surgery. Gut. 2016 Apr;65(4):625-34. doi: 10.1136/gutjnl-2014-308859. Epub 2015 Feb 4.

  PMID: 25654990 BACKGROUND

• Phallen J, Sausen M, Adleff V, Leal A, Hruban C, White J, Anagnostou V, Fiksel J, Cristiano S, Papp E, Speir S, Reinert T, Orntoft MW, Woodward BD, Murphy D, Parpart-Li S, Riley D, Nesselbush M, Sengamalay N, Georgiadis A, Li QK, Madsen MR, Mortensen FV, Huiskens J, Punt C, van Grieken N, Fijneman R, Meijer G, Husain H, Scharpf RB, Diaz LA Jr, Jones S, Angiuoli S, Orntoft T, Nielsen HJ, Andersen CL, Velculescu VE. Direct detection of early-stage cancers using circulating tumor DNA. Sci Transl Med. 2017 Aug 16;9(403):eaan2415. doi: 10.1126/scitranslmed.aan2415.

  PMID: 28814544 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tissue Plasma Serum

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

• Claus L Andersen, PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

• Søren Laurberg, MD, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Karen-Lise G Spindler, MD, PhD

  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: July 2, 2018
• First Posted: August 20, 2018
• Study Start: June 14, 2018
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2035
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

DK (10)