Circulating Tumor DNA Analysis to Optimize Treatment for Patients With Colorectal Cancer (IMPROVE)
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The overall objective of these studies are to confirm that ctDNA detected in plasma after intended curative treatment for CRC can be applied in clinical practice as a marker of subclinical residual disease and risk of recurrence.
Patients with high risk of recurrence can be identified with ctDNA profiling performed immediately after treatment for CRC. [ Time Frame: 3 years ]
3-year disease-free survival (3y-DFS)
Secondary Outcome Measures :
Association between ctDNA and the quality of primary surgery - the plane of the surgery [ Time Frame: 3 years ]
Association between presence of ctDNA measured by sequencing cfDNA and the plane of the surgery in the pathological specimen (muscular, intrameso-colic/rectal, meso-colic/rectal)
Association between ctDNA and the quality of primary surgery - the level of resection of the tumor feeding arteries [ Time Frame: 1 years ]
Association between presence of ctDNA measured by sequencing cfDNA and the length of the feeding artery in the resection specimen and the length of the artery residue in the patient measured on the first follow-up CT scan (at 12 month post-OP), respectively.
ctDNA profiling for evaluating quality improvement of surgery - before and after implementation of of a training program [ Time Frame: 3 years ]
ctDNA is measured by sequencing cfDNA. The rate of detection of ctDNA post-operatively is compared between resections performed before and after implementation of the training program at five Danish surgical centers.
ctDNA profiling for evaluating quality improvement of surgery - between centers with and without implementation of the training program [ Time Frame: 3 years ]
ctDNA is measured by sequencing cfDNA. The rate of detection of ctDNA post-operatively is compared between resections performed at centers with and without implementation of the training program.
Association between ctDNA and the effect of adjuvant chemotherapy [ Time Frame: 3 years ]
ctDNA measured by sequencing cfDNA. ctDNA measurements are performed before and after adjuvant chemotherapy. Changes in ctDNA level will be correlated to oncological outcome by measuring time to clinical recurrence, disease-free survival and overall survival.
Can ctDNA detect recurrence earlier than standard-of-care? [ Time Frame: 7 years ]
The difference between time to molecular recurrence (ctDNA detection) is compared to the time to clinical recurrence measured on CT scans..
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
All patients with stage I-III colon or rectal cancer, scheduled for curative intended resectional surgery.
Part I: Surgery
Colon or rectal cancer, clinical tumor stage I-III
Patient able to understand and sign written informed consent
Scheduled for curative intended resectional surgery
Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome
Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Verified distant metastases
Malignant colorectal polyps diagnosed after polypectomy
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
Part II: Surveillance:
One of the following:
TNM stage III CRC,
or TNM stage II CRC and risk factors qualifying for adjuvant chemotherapy,
or TNM stage I or stage II CRC without risk factors, but ctDNA positive in the post-operative day14 plasma sample. Inclusion requires that the patient declined participation in the IMPROVE IT trial.
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