Using blood tests to monitor colorectal cancer relapse and chemotherapy effectiveness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to utilize a multi-locus blood-based assay that targets circulating tumor DNA methylation to monitor postoperative relapse and evaluate the efficacy of adjuvant chemotherapy in patients with resected stage I and II colorectal cancer. Participants will be those who are ctDNA positive before surgery and will undergo regular treatment as per NCCN guidelines. Serial ctDNA analyses will be conducted at various time points, including pre-treatment and several postoperative intervals, to track cancer recurrence and treatment response. The study will follow participants for up to five years post-surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Second Affiliated Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Rui Liu, Ph.D — Singlera Genomics Inc.
• Study coordinator: HongFeng cao, Ph.D
• Email: hongfengcao@zju.edu.cn
• Phone: 13957117804

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.