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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Patients with high risk of recurrence can be identified with ctDNA profiling performed immediately after treatment for CRC. — 3 years 3-year disease-free survival (3y-DFS)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.