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Colorectal CancerNCT04084249

ctDNA-guided Surveillance for Stage III CRC, a Randomized Intervention Trial

A study testing ctDNA-analysis and Intensified Follow-up Schedule in people with Colorectal Cancer and Colo-rectal Cancer, run by Claus Lindbjerg Andersen at 10 sites in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Colo-rectal Cancer, ctDNA
What is being tested?
ctDNA-analysis and Intensified Follow-up Schedule
Could I receive a placebo?
No, everyone receives an active treatment
How many people
359 participants
Where
10 sitesDenmark
Study dates
1 Jan 2020to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Denmark10 sites

  • Aalborg University Hospital

    Aalborg, North Denmark, 9000

  • Aarhus University Hospital

    Aarhus, 8000

  • Bispebjerg Hospital

    Copenhagen, 2400

  • Herlev Hospital

    Herlev, Capital Region of Denmark, 2730

  • Gødstrup Hospital

    Herning, Central Jutland, 7400

  • Regional Hospital Horsens

    Horsens, Central Jutland, 8700

  • Zealand University Hospital

    Køge, 4600

  • Odense University Hospital

    Odense, The Region of Southern Denmark, 5000

  • Regional Hospital Randers

    Randers, Central Jutland, 8930

  • Regional Hospital Viborg

    Viborg, 8800

Other trials in Denmark

About this study

Official title: Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer - Intervention Trial 2

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.

Being tested
ctDNA-analysis, Intensified Follow-up Schedule
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Digestive System Diseases, Gastrointestinal Neoplasms, Digestive System Neoplasms, Colonic Diseases, Rectal Diseases, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ctDNA-analysisDiagnostic test

    Minimally-invasive blood-based analysis of circulating tumor DNA (ctDNA).

  • Intensified Follow-up ScheduleOther

    PET/CT-scans every 3. month

Study groups in NCT04084249
Study groupRoleWhat they receive
ctDNA guided surveillanceExperimentalctDNA 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.
Receives: Diagnostic Test: ctDNA-analysis; Other: Intensified Follow-up Schedule
Standard Danish follow-up programNo 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 years

Secondary outcomes (9)

  1. TTCR

    Time to clinical recurrence

    Measured: 3 years

  2. 3yr-OS

    Overall survival at 3 years

    Measured: 3 years

  3. 5yr-OS

    Overall survival at 5 years

    Measured: 5 years

  4. QoL

    Quality of Life by use of EORTC QLQ-C30, version 3.0. The QoL outcome measure is differences in QLQ-C30 score at 12, 24 and 36 months between the experimental and control arm.

    Measured: 3 years

  5. CE

    Cost-effectiveness. QoL/Utility weights for the quality-adjusted life years parameter will be QLU-C10D based on EORTC QLQ-C30.

    Measured: 5 years

  6. AR

    Adherence rate for patients following ctDNA-guided and standard of care surveillance

    Measured: 3 years

  7. TTMR

    Time to molecular recurrence

    Measured: 2 years

  8. FCRI

    Fear of Cancer Recurrence Inventory. The FCRI outcome measure is differences in FCRI at 12, 24 and 36 months between the experimental and control arm.

    Measured: 3 years

  9. IES-C

    Impact of Events Scale Cancer. The IES-C outcome measure is differences in IES-C at 12, 24 and 36 months between the experimental and control arm.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2019
  2. Study start1 Jan 2020
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
359 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04084249
Sponsor's protocol ID
IMPROVE-IT2
Status last verified
Apr 2026
First submitted
4 Sep 2019
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31920137

Questions about this trial

What is this clinical trial studying?

A study testing ctDNA-analysis and Intensified Follow-up Schedule in people with Colorectal Cancer and Colo-rectal Cancer, run by Claus Lindbjerg Andersen at 10 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FCI (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04084249, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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