ctDNA-guided Surveillance for Stage III CRC, a Randomized Intervention Trial
NCT ID: NCT04084249
Last Updated: 2024-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
359 participants
INTERVENTIONAL
2020-01-01
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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ctDNA guided surveillance
ctDNA 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.
ctDNA-analysis
Minimally-invasive blood-based analysis of circulating tumor DNA (ctDNA).
Intensified Follow-up Schedule
PET/CT-scans every 3. month
Standard Danish follow-up program
Patients 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).
No interventions assigned to this group
Interventions
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ctDNA-analysis
Minimally-invasive blood-based analysis of circulating tumor DNA (ctDNA).
Intensified Follow-up Schedule
PET/CT-scans every 3. month
Eligibility Criteria
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Inclusion Criteria
* Have received curative intend resection and be candidates for adjuvant chemotherapy
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Claus Lindbjerg Andersen
OTHER
Responsible Party
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Claus Lindbjerg Andersen
Professor
Principal Investigators
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Claus L Andersen, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Molecular Medicin, Aarhus University Hospital
Locations
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Herlev Hospital
Herlev, Capital Region of Denmark, Denmark
Gødstrup Hospital
Herning, Central Jutland, Denmark
Regional Hospital Horsens
Horsens, Central Jutland, Denmark
Regional Hospital Randers
Randers, Central Jutland, Denmark
Aalborg University Hospital
Aalborg, North Denmark, Denmark
Odense University Hospital
Odense, The Region of Southern Denmark, Denmark
Aarhus University Hospital
Aarhus, , Denmark
Bispebjerg Hospital
Copenhagen, , Denmark
Zealand University Hospital
Køge, , Denmark
Regional Hospital Viborg
Viborg, , Denmark
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Statistical Analysis Plan
Other Identifiers
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IMPROVE-IT2
Identifier Type: -
Identifier Source: org_study_id
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