Circulating Tumor DNA Methylation-Guided Adjuvant Therapy Decision-Making in Patients With Resectable Colorectal Cancer Liver Metastases After Resection
NCT07917104, Phase 2, Recruiting, Fudan University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Circulating Tumor DNA Methylation-Guided Adjuvant Therapy Decision-Making in Patients With Resectable Colorectal Cancer Liver Metastases After Resection | ClinicalTrials.gov |
| NCT number | NCT07917104 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 220 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fudan University | ClinicalTrials.gov |
| Conditions | Colorectal Cancer Liver Metastases (CRLM), ctDNA | ClinicalTrials.gov |
| Interventions | Circulating Tumor DNA Methylation Testing, Conventional Postoperative Treatment Strategy | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Recurrence-Free Survival (RFS) | From randomization through the end of the two-year postoperative follow-up. | Time from randomization to the first imaging-confirmed local recurrence or distant metastasis, assessed according to RECIST 1.1, or death from any cause, whichever occurs first. Participants without an event at the last follow-up will be censored at that date. RFS will be compared between the ctDNA methylation-guided treatment group and the conventional treatment group. | ClinicalTrials.gov |
| Secondary | Overall Survival (OS) | From randomization through the end of the two-year postoperative follow-up. | Time from randomization to death from any cause. Participants who are alive at the last follow-up will be censored at that date. OS will be compared between the two treatment groups. | ClinicalTrials.gov |
| Secondary | Postoperative ctDNA Methylation Positivity Rate | One week after surgery (±3 days). | Proportion of all enrolled participants with positive ctDNA methylation results one week after surgery. Associations between postoperative ctDNA methylation status and clinicopathological characteristics will also be assessed. | ClinicalTrials.gov |
| Secondary | Agreement Between ctDNA Methylation Status and Imaging Findings | During the two-year postoperative follow-up. | Agreement between ctDNA methylation status and imaging-based no evidence of disease (NED) status. | ClinicalTrials.gov |
| Secondary | Lead Time From ctDNA Methylation Positivity to Imaging-Confirmed Recurrence | During the two-year postoperative follow-up. | Median time interval from ctDNA methylation positivity to subsequent imaging-confirmed recurrence. | ClinicalTrials.gov |
| Secondary | Secondary No Evidence of Disease (NED) Conversion Rate | During the two-year postoperative follow-up. | Proportion of all participants with recurrence who receive curative-intent local treatment after recurrence and achieve NED. This proportion will be compared between the two treatment groups. | ClinicalTrials.gov |
| Secondary | ctDNA Methylation Clearance Rate | During treatment and subsequent follow-up, through the end of the two-year postoperative follow-up. | Proportion of participants in the ctDNA methylation-guided treatment group with initially positive ctDNA results who become ctDNA negative after treatment. The association between ctDNA clearance and RFS will be explored. | ClinicalTrials.gov |
| Secondary | Time to ctDNA Methylation Clearance | During treatment and subsequent follow-up, through the end of the two-year postoperative follow-up. | Median time to conversion from ctDNA positivity to negativity after treatment in participants with initially positive ctDNA results in the ctDNA methylation-guided treatment group. | ClinicalTrials.gov |
| Secondary | ctDNA Methylation Test Reporting Turnaround Time | At ctDNA methylation testing time points during the two-year postoperative follow-up. | Turnaround time for reporting ctDNA methylation test results, with a target of no more than five working days, and its impact on the timeliness of clinical decision-making. | ClinicalTrials.gov |
| Secondary | Patient-reported Quality of Life | During the two-year postoperative follow-up. | Patient-reported quality of life assessed using the EORTC QLQ-C30 questionnaire. Quality of life will be compared between the ctDNA methylation-guided treatment group and the conventional treatment group. | ClinicalTrials.gov |
| Secondary | Incremental Cost-Effectiveness Ratio (ICER) | During the two-year postoperative follow-up. | Health economic evaluation of the ctDNA methylation-guided treatment strategy compared with conventional treatment using the incremental cost-effectiveness ratio. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)