Using blood tests to monitor colorectal cancer relapse and chemotherapy effectiveness

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

This study is testing a blood test that looks for cancer DNA to see if it can help track cancer coming back and how well chemotherapy works for people who had early-stage colorectal cancer.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Singlera Genomics Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05536089 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed stage I or II colorectal cancer who are ctDNA positive prior to surgical resection.

Not a fit: Patients with a personal history of colorectal cancer, those who have undergone neoadjuvant therapy, or those with certain confounding conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier detection of cancer relapse and more effective monitoring of chemotherapy outcomes for colorectal cancer patients.

How similar studies have performed: Other studies utilizing ctDNA for cancer monitoring have shown promising results, indicating potential success for this approach.

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.

Where this trial is running

Hangzhou, Zhejiang

• Second Affiliated Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Rui Liu, Ph.D — Singlera Genomics Inc.
• Study coordinator: HongFeng cao, Ph.D

Conditions Cancer Colorectal; early detection