Clinical trial · Observational
A Prospective Study of UCAD for Diagnosing Benign or Malignant Biliary Obstruction and Follow-up
A Prospective, Multi-centre, Single-blinded Study of UCAD for Diagnosing Benign or Malignant Biliary Obstruction and Follow-up
- 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)
Chromosomal instability (CIN) refers to ongoing chromosome segregation errors throughout consecutive cell divisions. CIN is a hallmark of human cancer, and it is associated with poor prognosis, metastasis, and therapeutic resistance. Analyzing CIN of the DNA extracted from bile tract exfoliated cells in bile samples seems a promising method for diagnosing, monitoring, and predicting the prognosis of patients with malignant biliary obstruction, including biliary tract cancer (BTC), pancreatic head carcinoma. CIN can be assessed using experimental techniques such as bulk DNA sequencing, fluorescence in situ hybridization (FISH), or conventional karyotyping. However, these techniques are either time-consuming or non-specific. The investigators here intend to study whether a new method named Ultrasensitive Chromosomal Aneuploidy Detection (UCAD), which is based on low-coverage whole-genome sequencing, can be used to analyze CIN thus helping diagnose malignant biliary obstruction and assessing follow-up.
Conditions
Conditions (4)
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 Neoplasms | — | UNRESOLVED | — |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Carcinoma | Pancreatic Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Head Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The level of CIN | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- malignant biliary obstruction
- description
- Pre-surgery patients with malignant biliary obstruction will be the experimental group to determine the sensitivity and specificity of UCAD analysis, the result will be compared with cytology.
- interventionNames
- Diagnostic Test: The level of CIN
- label
- Benign biliary obstruction
- description
- Patients being treated for other biliary diseases but without any tumor will provide a negative control to provide data for determining the sensitivity and specificity of UCAD analysis.
- interventionNames
- Diagnostic Test: The level of CIN
Primary outcomes (2)
- measure
- Sensitivity and Specificity of UCAD analysis
- timeFrame
- through study completion, an average of 30 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with malignant biliary obstruction and planned to undergo ERCP(endoscopic retrograde cholangiopancreatography), PTCS(percutaneous transhepatic cholangioscopy) or surgery. * Malignant biliary obstruction patients confirmed by operation or biopsy. * Participants without any tumor disease and willing to attend the study. * Male or female patients aged \>= 18 years. * Participants signed informed consent form. Exclusion Criteria: * Patients diagnosed with malignant biliary obstruction and planned to undergo ERCP, PTCS or surgery. * Malignant biliary obstruction patients confirmed by operation or biopsy. * Participants without any tumor disease and willing to attend the study. * Male or female patients aged \>= 18 years. * Participants signed informed consent form.
References
Publications (2)
- BACKGROUNDHieronymus H, Murali R, Tin A, Yadav K, Abida W, Moller H, Berney D, Scher H, Carver B, Scardino P, Schultz N, Taylor B, Vickers A, Cuzick J, Sawyers CL. Tumor copy number alteration burden is a pan-cancer prognostic factor associated with recurrence and death. Elife. 2018 Sep 4;7:e37294. doi: 10.7554/eLife.37294. PMID 30178746
- BACKGROUNDBakhoum SF, Ngo B, Laughney AM, Cavallo JA, Murphy CJ, Ly P, Shah P, Sriram RK, Watkins TBK, Taunk NK, Duran M, Pauli C, Shaw C, Chadalavada K, Rajasekhar VK, Genovese G, Venkatesan S, Birkbak NJ, McGranahan N, Lundquist M, LaPlant Q, Healey JH, Elemento O, Chung CH, Lee NY, Imielenski M, Nanjangud G, Pe'er D, Cleveland DW, Powell SN, Lammerding J, Swanton C, Cantley LC. Chromosomal instability drives metastasis through a cytosolic DNA response. Nature. 2018 Jan 25;553(7689):467-472. doi: 10.1038/nature25432. Epub 2018 Jan 17. PMID 29342134