Clinical trial · Observational
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies
Development and Validation of the Performance of a cfDNA Methylation-based Model Combined With Serum Tumor Markers for Early Hepatobiliary Malignancies Detection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective, multicenter study aimed to develop and validate the performance of combined assays for cfDNA methylation markers and serum tumor markers in early hepatobiliary malignancies detection. Circulating tumor DNA (ctDNA) mutation, blood RNA markers and tissue will also be evaluated. The study will enroll approximately 496 participants, including participants with malignant or benign diseases of the hepatobiliary system.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatobiliary Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-cancer early detection test | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cancer Arm
- description
- Participants with new diagnosis of hepatobiliary malignancies, from whom blood samples will be collected
- interventionNames
- Device: Multi-cancer early detection test
- label
- Benign Diseases Arm
- description
- Participants with benign diseases of the hepatobiliary system, from whom blood samples will be collected
- interventionNames
- Device: Multi-cancer early detection test
Primary outcomes (2)
- measure
- Sensitivity of early hepatobiliary malignancies detection and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model combined with serum tumor markers when specificity was 90%, 95% or 98%
- timeFrame
- 16 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria for All the Participants: * 40-75 years old * Ability to comply with study procedures * Ability to provide a written informed consent Exclusion Criteria for All the Participants: * Pregnancy or lactating women * Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 7 days prior to study blood draw * Recipients of anti-microbial therapy within 14 days prior to study blood draw * Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer Inclusion Criteria for Cancer Arm Participants: * Confirmed diagnosis or highly suspicious cases of hepatobiliary malignancies * No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw Exclusion Criteria for Cancer Arm Participants: * Current diagnosis of other malignancies or multiple primary tumors * Diagnosis of benign diseases by histopathological assessments * Inability to characterize whether the lesion is malignant or benign * Prior or ongoing treatment of cancer Inclusion Criteria for Benign Diseases Arm Participants: * Confirmed diagnosis of benign diseases of the hepatobiliary system * No prior radical treatment of the benign diseases prior to study blood draw Exclusion Criteria for Benign Diseases Arm Participants: * Current or history of malignancies or precancerous lesions * No confirmed diagnosis or inability to characterize a benign disease
References
Publications (0)
Data not yet available