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NCT04084249Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 29 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
359 (actual)
First submitted
4 Sept 2019
Start date
1 Jan 2020
Primary completion date
30 Jun 2028
Lead sponsor
Claus Lindbjerg Andersen
NCT number
NCT04084249

What you commit to

  • Study type: Interventional
  • Participants enrolled: 359
  • From 1 Jan 2020 to the primary completion date, 30 Jun 2028
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Not treated with adjuvant chemotherapy

Other illness

  • 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

Other

  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aalborg University Hospital
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AalborgDenmarkUnknown status
Aarhus University Hospital
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AarhusDenmarkUnknown status
Bispebjerg Hospital
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CopenhagenDenmarkUnknown status
Herlev Hospital
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HerlevDenmarkUnknown status
Gødstrup Hospital
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HerningDenmarkUnknown status
Regional Hospital Horsens
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HorsensDenmarkUnknown status
Zealand University Hospital
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KøgeDenmarkUnknown status
Odense University Hospital
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OdenseDenmarkUnknown status
Regional Hospital Randers
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RandersDenmarkUnknown status
Regional Hospital Viborg
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ViborgDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.