Clinical trial · Observational
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Biliary Tract Cancer (ASCEND-BTC)
Exploration and Validation of a Diagnosis Model for Biliary Tract Cancer Based on Combined Liquid Biopsy in Peripheral Blood: A Multi-center Prospective Study
NCT05667350CI-TRIAL-00062956unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
ASCEND-BTC is a prospective, multi-center, observational study aimed at detecting early biliary tract cancer by combined assays of serum protein and cell-free DNA (cfDNA) methylation. The study will enroll approximately 492 participants diagnosed with biliary tract cancer and benign diseases.
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 |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood drawing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cancer arm
- description
- Baseline blood samples will be collected from participants newly diagnosed with biliary tract cancer.
- interventionNames
- Other: Blood drawing
- label
- Benign disease arm
- description
- Baseline blood samples will be collected from participants newly diagnosed with benign biliary tract diseases.
- interventionNames
- Other: Blood drawing
Primary outcomes (1)
- measure
- The sensitivity and specificity of the combined model in detection of biliary tract cancers.
- timeFrame
- 24 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria for Cancer Arm Participants: * Age 40-75 years at the day of consenting to the study. * Able to provide a written informed consent * Pathologically confirmed biliary tract cancers. * No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw. Exclusion Criteria for Cancer Arm 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 any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancers. * With other known malignant tumors or multiple primary tumors. Inclusion Criteria for Benign Arm Participants: * Age 40-75 years at the day of consenting to the study. * Able to provide a written informed consent. * Confirmed diagnosis of benign biliary tract diseases. * No prior radical treatment of the benign diseases prior to study blood draw. Exclusion Criteria for Benign Arm 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 any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancers. * Confirmed diagnosis of malignancies or precancerous lesion. * A history of malignant tumors.
References
Publications (0)
Data not yet available
No reference posted for this study.