Blood test may spot cancer recurrence months before standard scans
NCT ID NCT05904665
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether a blood test that looks for tumor DNA (ctDNA) can detect colorectal cancer recurrence earlier than usual methods like CT scans and CEA blood tests. About 584 people with stage I-III colorectal cancer who had surgery will be randomly assigned to either standard follow-up or ctDNA monitoring every 3 months for 2 years. The goal is to see if ctDNA testing leads to more patients receiving curative treatment when cancer returns.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ctDNA methylation test (blood test)
- What this could lead to
- If successful, this blood test could detect colorectal cancer recurrence months earlier than current methods, allowing for earlier treatment and potentially improving survival.
- What could go wrong
- This is a diagnostic study, not a treatment trial. The test may not prove more effective than standard monitoring, and earlier detection does not guarantee better outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 584 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2023
- Expected to finish
-
Jun 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years old, regardless of gender; 2. Personal status (PS) score as over 80 or Eastern Cooperative Oncology Group (ECOG) score as 0 \~ 2; 3. Preoperative imaging examinations reveal no definite distant metastatic lesions, and postoperative pTNM staging confirms patients with stage I to III colorectal cancer; 4. Radical operation performed ; 5. With expected survival of more than 12 months; 6. The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study. Exclusion Criteria: 1. Blood transfusion performed during operation or within 2 weeks before operation; 2. Incomplete baseline samples, including preoperative plasma samples; 3. Two consecutive test points missing or three plasma samples missing in total before a positive ctDNA time point; 4. Pregnant or lactating women who have fertility and do not take adequate contraceptive measures; 5. Have a history of other malignant tumors within 5 years, except cured cervical carcinoma in situ or non melanoma skin cancer; 6. Primary brain tumor or central nerve metastasis is not under control, with obvious intracranial hypertension or neuropsychiatric symptoms; 7. Patients with the following serious or uncontrollable diseases: severe heart disease, the condition is still unstable after treatment, including myocardial infarction, congestive heart failure, unstable angina pectoris, pericardial effusion with obvious symptoms or unstable arrhythmia within 6 months before enrollment; definite neuropathy or psychosis, including dementia or seizures; severe or uncontrolled infection; active disseminated intravascular coagulation and obvious bleeding tendency; 8. Significant impairment of important organ function; 9. Other conditions in which the investigator believes that the patient should not participate in this trial.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Circulating tumor DNA methylation are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.