IMPROVE: Circulating Tumor DNA Analysis to Optimize Treatment for Patients With Colorectal Cancer (NCT03637686) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
IMPROVE: Circulating Tumor DNA Analysis to Optimize Treatment for Patients With Colorectal Cancer
Denmark3,182 participantsStarted 2018-06-14
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Part I: Surgery
Inclusion Criteria:
* Colon or rectal cancer, clinical tumor stage I-III
* Patient able to understand and sign written informed consent
* Scheduled for curative intended resectional surgery
Exclusion Criteria:
* 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:
Inclusion criteria:
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.
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
What they're measuring
1
Patients with high risk of recurrence can be identified with ctDNA profiling performed immediately after treatment for CRC.