ctDNA-guided Surveillance for Stage III CRC, a Randomized Intervention Trial
Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer - Intervention Trial 2
1 other identifier
interventional
359
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2019
CompletedFirst Posted
Study publicly available on registry
September 10, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
April 29, 2026
April 1, 2026
8.5 years
September 4, 2019
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
FCI
Fraction of patients with relapse receiving intended curative resection or local treatment aiming at complete tumor destruction as defined at the relevant MDT conference.
5 years
Secondary Outcomes (9)
TTCR
3 years
3yr-OS
3 years
5yr-OS
5 years
QoL
3 years
CE
5 years
- +4 more secondary outcomes
Study Arms (2)
ctDNA guided surveillance
EXPERIMENTALctDNA analysis will be performed every 4 months postoperatively (4, 8, 12, 16, 20 and 24). At time of first positive ctDNA, patients undergo a whole-body FDG-PET/CT-scan for radiological assessment and a colonoscopy. If the initial assessment is without evidence of recurrence, patients will be offered high-intensive radiological surveillance with FDG-PET/CT-scans every 3 months, until recurrence detection or 21 months has passed. At baseline and months 12, 18, 24 and 36 patients complete the QoL questionnaires including EORTC QLQ-C30, fear of cancer recurrence inventory (FCRI), and impact of events scale for cancer (IES-C). At every FDG-PET/CT-scans the patients also complete the questionnaire.
Standard Danish follow-up program
NO INTERVENTIONPatients will undergo surveillance according to current Danish Guidelines with CT-scans at months 12 and 36 postoperative and colonoscopy every 5 year until age 75. Longitudinal blood samples will be collected at same time-points as in the experimental group but not analyzed until end of trial. At baseline and months 12, 18, 24 and 36 patients complete the QoL questionnaires including EORTC QLQ-C30, fear of cancer recurrence inventory (FCRI), and impact of events scale for cancer (IES-C).
Interventions
Minimally-invasive blood-based analysis of circulating tumor DNA (ctDNA).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Claus Lindbjerg Andersenlead
- University of Aarhuscollaborator
Study Sites (10)
Herlev Hospital
Herlev, Capital Region of Denmark, 2730, Denmark
Gødstrup Hospital
Herning, Central Jutland, 7400, Denmark
Regional Hospital Horsens
Horsens, Central Jutland, 8700, Denmark
Regional Hospital Randers
Randers, Central Jutland, 8930, Denmark
Aalborg University Hospital
Aalborg, North Denmark, 9000, Denmark
Odense University Hospital
Odense, The Region of Southern Denmark, 5000, Denmark
Aarhus University Hospital
Aarhus, 8000, Denmark
Bispebjerg Hospital
Copenhagen, 2400, Denmark
Zealand University Hospital
Køge, 4600, Denmark
Regional Hospital Viborg
Viborg, 8800, Denmark
Related Publications (1)
Nors J, Henriksen TV, Gotschalck KA, Juul T, Sogaard J, Iversen LH, Andersen CL. IMPROVE-IT2: implementing noninvasive circulating tumor DNA analysis to optimize the operative and postoperative treatment for patients with colorectal cancer - intervention trial 2. Study protocol. Acta Oncol. 2020 Mar;59(3):336-341. doi: 10.1080/0284186X.2019.1711170. Epub 2020 Jan 10. No abstract available.
PMID: 31920137BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claus L Andersen, PhD
Department of Molecular Medicin, Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 4, 2019
First Posted
September 10, 2019
Study Start
January 1, 2020
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share