Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Aarhus | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ctDNA guided surveillance | Experimental | 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. |
|
| Standard Danish follow-up program | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ctDNA-analysis | Diagnostic Test | Minimally-invasive blood-based analysis of circulating tumor DNA (ctDNA). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| TTCR | Time to clinical recurrence | 3 years |
| 3yr-OS | Overall survival at 3 years | 3 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claus L Andersen, PhD | Department of Molecular Medicin, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital | Herlev | Capital Region of Denmark | 2730 | Denmark | ||
| Gødstrup Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31920137 | Background | 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. |
| Label | URL |
|---|---|
| Statistical Analysis Plan | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 3, 2024 | Jul 4, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intensified Follow-up Schedule | Other | PET/CT-scans every 3. month |
|
| 5yr-OS | Overall survival at 5 years | 5 years |
| 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. | 3 years |
| CE | Cost-effectiveness. QoL/Utility weights for the quality-adjusted life years parameter will be QLU-C10D based on EORTC QLQ-C30. | 5 years |
| AR | Adherence rate for patients following ctDNA-guided and standard of care surveillance | 3 years |
| TTMR | Time to molecular recurrence | 2 years |
| 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. | 3 years |
| 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. | 3 years |
| 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 |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 25, 2024 | Jun 26, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D004066 | Digestive System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D003108 | Colonic Diseases |
| D012002 | Rectal Diseases |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided