Clinical trial · Observational
Application of Chromosomal Instability in Early Diagnosis of Biliary Tract Carcinoma
Application of Chromosomal Instability and Metagenomic Detection in Early Diagnosis of Biliary Tract Carcinoma in Bile
- 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 cast-off cells in bile samples seems a promising method for diagnosing, monitoring, and predicting the prognosis of biliary tract carcinoma patients. 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 Bile Ultrasensitive Chromosomal Aneuploidy Detection (BileCAD), which is based on low-coverage whole-genome sequencing, can be used to analyze CIN and microbial infection analysis thus help diagnosing and treating biliary tract carcinoma patients.
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 Carcinoma | Biliary Tract Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The extracted DNA from bile samples will be analyzed by BileCAD to determine the level of CIN. | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Biliary tract carcinoma patients
- description
- Biliary tract carcinoma patients will be the experimental group to determine the sensitivity of BileCAD analysis.
- interventionNames
- Diagnostic Test: The extracted DNA from bile samples will be analyzed by BileCAD to determine the level of CIN.
- label
- Non-cancer participants Patients
- description
- Non-cancer participants Patients being treated for other diseases but without any tumor will provide a negative control to provide data for determining the specificity of BileCAD analysis.
- interventionNames
- Diagnostic Test: The extracted DNA from bile samples will be analyzed by BileCAD to determine the level of CIN.
Primary outcomes (2)
- measure
- Sensitivity of bile sample analysis by BileCADanalysis
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * No systemic therapy or biliary tract surgery before the trial. * Gallstones, bile duct space, obstructive jaundice and other suspected patients with biliary tract carcinoma. * Male or female patients aged \>= 18 years. * Participants signed informed consent form. Exclusion Criteria: * Age under 18 years. * Individuals unwilling to sign the consent form or unwilling to provide the medical record. * Individuals unwilling to participate in this trial. * Individuals has any active autoimmune disease or history of autoimmune disease. * Individuals have cardiac clinical symptoms or diseases that are not well controlled. * Individuals have uncontrolled severe cerebrovascular, pulmonary and other diseases.
References
Publications (5)
- BACKGROUNDRichardson TE, Walker JM, Abdullah KG, McBrayer SK, Viapiano MS, Mussa ZM, Tsankova NM, Snuderl M, Hatanpaa KJ. Chromosomal instability in adult-type diffuse gliomas. Acta Neuropathol Commun. 2022 Aug 17;10(1):115. doi: 10.1186/s40478-022-01420-w. PMID 35978439
- BACKGROUNDAl-Rawi DH, Bakhoum SF. Chromosomal instability as a source of genomic plasticity. Curr Opin Genet Dev. 2022 Jun;74:101913. doi: 10.1016/j.gde.2022.101913. Epub 2022 May 5. PMID 35526333
- BACKGROUNDBach DH, Zhang W, Sood AK. Chromosomal Instability in Tumor Initiation and Development. Cancer Res. 2019 Aug 15;79(16):3995-4002. doi: 10.1158/0008-5472.CAN-18-3235. Epub 2019 Jul 26. PMID 31350294
- BACKGROUNDLiu Y, Yeh MM. Bile duct dysplasia and associated invasive carcinoma: clinicopathological features, diagnosis, and practical challenges. Hum Pathol. 2023 Feb;132:158-168. doi: 10.1016/j.humpath.2022.06.012. Epub 2022 Jun 14. PMID 35714833
- BACKGROUNDOnoyama T, Matsumoto K, Koda H, Yamashita T, Kurumi H, Kawata S, Takeda Y, Harada K, Yashima K, Isomoto H. Diagnostic usefulness of KL-6 concentration of bile in biliary tract cancer. Mol Clin Oncol. 2018 Apr;8(4):561-566. doi: 10.3892/mco.2018.1571. Epub 2018 Feb 12. PMID 29541466