Official Title
ctDNA Methylation Used to Monitor Postoperative Relapse and Evaluate Adjuvant Chemotherapy Efficacy in Resected Stage I and Stage II (Without High Risk) Colorectal Cancer After Radical Resection
Brief Title
ctDNA Methylation Application in Postoperative Relapse and Adjuvant Chemotherapy Efficacy Evaluation
Protocol ID
NCT05536089
Lead Sponsor
Singlera Genomics Inc.
Brief Summary
In this study, the investigators aimed to apply their previously developed multi-locus
blood-based assay targeting circulating tumor DNA methylation to monitor postoperative
relapse and evaluate adjuvant chemotherapy efficacy in resected stage I and stage II
(without high risk) colorectal cancer after radical resection.
Detailed Description
This is a prospective, multicenter, observational, real-world study. Research objects:
patients with surgically resectable colorectal cancer and ctDNA positive before surgery
in stage I and stage II (without high risk). After giving fully informed consent, the
participants will undergo the regular treatment according to NCCN guidelines. Serial
analysis of ctDNA will be performed at specific time points including pre-treatment,
postoperative week 3, postoperative 5 years ( every 3 months for the first 2 years, and
every 6 months for the rest 3 years). Participants will be observed and examined during
the follow-up period.
Study Period
Enrollment Count
2,000 participants
Eligibility Criteria
Inclusion Criteria:
- Patients must have histologically confirmed stage I/II (without high risk)
colorectal cancer.
- Male or female ≥ 18 years of age on the day of signing informed consent.
- Patients need to receive surgical resection, and with ctDNA positive prior to
resection of colorectal cancer (CRC).
- Patients must have a performance status of ≤1 on the Eastern Cooperative Oncology
Group (ECOG) Performance Scale.
- Written informed consent must be obtained from patient or patient's legal
representative and ability for patient to comply with the requirements of the study.
Exclusion Criteria:
- Personal history of colorectal cancer, colorectal adenoma or aerodigestive tract
cancer.
- Induction of neoadjuvant systemic therapy prior to resection of CRC.
- Patient is pregnant or lactating.
- Patients with a history or current evidence of any condition or abnormality that
might confound the results of the study, interfere with the patient's participation
for the full duration of the study, or is not in the best interest of the patient to
participate, in the opinion of the Investigator.
- Inadequate tumor material (either quality and quantity) to support circulating tumor
DNA (ctDNA) analysis.
Filters
Cancer Colorectal
RECRUITING
ADULT
OLDER_ADULT