Trials / Unknown
UnknownNCT05393102
Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome Signatures
Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome SignatuRes (GUDIER): an Observational Cohort Trial
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 400 (estimated)
- Sponsor
- The Second Affiliated Hospital of Chongqing Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
As a prospective, multi-center study, GUIDER will recruit 400 liver nodules participants from different provinces and regions across China. Except for cfDNA signatures, serum biomarkers, histopathological biopsy and enhanced MRI will also be performed. The sensitivity and specificity of the cfDNA signature based-model in liver nodules diagnosing will be evaluated.
Detailed description
Patients with liver nodules will be recruited for 1 year. Peripheral blood samples of all participants will be collected after being informed about the study and potential risks. CfDNA extraction, library construction, and whole genome sequencing will be performed. A machine learning method will be implemented for cfDNA signatures-based model construction at the end of the study. Sensitivity and specificity will be used to evaluate the performance of cfDNA signatures-based model in liver nodules diagnosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No interventions | No interventions |
Timeline
- Start date
- 2022-05-01
- Primary completion
- 2023-04-01
- Completion
- 2023-10-01
- First posted
- 2022-05-26
- Last updated
- 2022-05-26
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05393102. Inclusion in this directory is not an endorsement.