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ctDNA Methylation Application in Postoperative Relapse and Adjuvant Chemotherapy Efficacy Evaluation

ConditionCancer Colorectal
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSinglera Genomics Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent must be obtained from the patient prior to enrollment. The following criteria apply to all patients enrolled onto the study unless otherwise specified.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • a multi-locus blood-based assay

    Diagnostic test

    Colorectal tumor-specific plasma ctDNA methylation markers detection

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: ctDNA positive1 intervention
Group B: ctDNA negative1 intervention

Trial outcomes

Primary outcomes

1

5y DFS

The 5-year disease free survival rate of the patients from both cohorts.

Time frame
5 years
2

ctDNA methylation markers versus CT/MRI

ctDNA methylation predictors of outcome will be compared to CT/MRI

Time frame
5 years

Secondary outcomes

1

3y DFS

The 3-year disease free survival rate of the patients from both cohorts.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Singlera Genomics Inc.

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborator

Source ClinicalTrials.gov
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