Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer - Intervention Trial 2 (IMPROVE-IT2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04084249|
Recruitment Status : Not yet recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Colo-rectal Cancer ctDNA Gastro-Intestinal Disorder Colorectal Neoplasms Gastrointestinal Cancer Gastrointestinal Neoplasms Digestive System Disease Digestive System Neoplasm Colonic Diseases Colonic Neoplasms Colonic Cancer Rectal Diseases Rectal Neoplasms Rectal Cancer||Diagnostic Test: ctDNA-analysis Other: Intensified Follow-up Schedule||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||254 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer - Intervention Trial 2|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 1, 2025|
Experimental: 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 months 4, 12, 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 FCRI questionnaire.
Diagnostic Test: ctDNA-analysis
Minimally-invasive blood-based analysis of circulating tumor DNA (ctDNA).
Other: Intensified Follow-up Schedule
PET/CT-scans every 3. month
No Intervention: 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 months 4, 12, 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).
- FCI [ Time Frame: 5 years ]Fraction of patients with relapse receiving intended curative resection or local treatment aiming at complete tumor destruction as defined at the relevant MDT conference.
- 3yr-OS [ Time Frame: 3 years ]Overall survival at 3 years
- 5yr-OS [ Time Frame: 5 years ]Overall survival at 5 years
- TTCR [ Time Frame: 3 years ]Time to clinical recurrence
- TTMR [ Time Frame: 2 years ]Time to molecular recurrence
- QoL [ Time Frame: 3 years ]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.
- FCRI [ Time Frame: 3 years ]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.
- IES-C [ Time Frame: 3 years ]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.
- CE [ Time Frame: 5 years ]Cost-effectiveness. QoL/Utility weights for the quality-adjusted life years parameter will be QLU-C10D based on EORTC QLQ-C30.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084249
|Contact: Claus L Andersen, PhD||+45 firstname.lastname@example.org|
|Contact: Kaare A Gotschalck, PhD||+45 email@example.com|
|Principal Investigator:||Claus L Andersen, PhD||Department of Molecular Medicin, Aarhus University Hospital|