MedDataX Logo

Application of Chromosomal Instability in Early Diagnosis of Biliary Tract Carcinoma

NCT ID: NCT05845554

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-30

Study Completion Date

2024-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Biliary tract carcinoma account for about 3% of all digestive system tumors, with potential high metastasis and invasion ability. Their early clinical symptoms lack specificity, and they are often found in late stage with poor prognosis. CIN results from errors in chromosome segregation during mitosis, leading to structural and numerical chromosomal abnormalities. It will generate genomic heterogeneity that acts as a substrate for natural selection. Furthermore, it is proved that tumors with aneuploidies and polyploidy resulting from whole-genome doubling are related with metastasis, treatment resistance, and decreased overall survival. It is estimated that 60%-80% of human tumors exhibit chromosomal abnormalities suggestive of CIN. CIN positively correlates with tumor stage and is enriched in relapsed as well as metastatic tumor specimens. Due to the ubiquity of CIN in cancer cells, it is a potentially way to detect CIN in the cast-off cells from the bile samples for diagnosing and monitoring biliary tract carcinoma patients. BileCAD is a new method to detecting CIN in the DNA sample from patients, including extracting DNA from bile, analyzing DNA by low-coverage whole-genome sequencing, processing the data by bio-information techniques, and finally optimizing the management of biliary tract carcinoma patients.The investigators intended to conduct a prospective study by analyzing bile samples from gallbladder cancers and cholangiocarcinoma patients and control groups that without any tumor in the Bile duct and gallbladder or other organs to compare the specificity and sensitivity of BileCAD test for diagnosing biliary tract carcinoma to other modalities, such as pathological diagnosis. At the same time, the consistency of BileCAD microbial analysis results and clinical microbial culture results was compared, so as to provide more reference for clinical diagnosis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Biliary Tract Carcinoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Biliary Tract Carcinoma chromosomal instability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Biliary tract carcinoma patients

Biliary tract carcinoma patients will be the experimental group to determine the sensitivity of BileCAD analysis.

The extracted DNA from bile samples will be analyzed by BileCAD to determine the level of CIN.

Intervention Type DIAGNOSTIC_TEST

The extracted gDNA from bile sample will be analyzed by BileCAD to determine the level of CINs.

Non-cancer participants Patients

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.

The extracted DNA from bile samples will be analyzed by BileCAD to determine the level of CIN.

Intervention Type DIAGNOSTIC_TEST

The extracted gDNA from bile sample will be analyzed by BileCAD to determine the level of CINs.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The extracted DNA from bile samples will be analyzed by BileCAD to determine the level of CIN.

The extracted gDNA from bile sample will be analyzed by BileCAD to determine the level of CINs.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taizhou First People's Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role collaborator

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fabiao zhang

department director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

fabiao zhang

Role: PRINCIPAL_INVESTIGATOR

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

yunfeng shan

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Wenzhou Medical University

ning mu

Role: PRINCIPAL_INVESTIGATOR

Taizhou First People's Hospital

xiao liang

Role: PRINCIPAL_INVESTIGATOR

Sir Run Run Shaw Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sir Run Run Shaw Hospital, School of Medicine，Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Taizhou First People's Hospital

Taizhou, Zhejiang, China

Site Status RECRUITING

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Site Status RECRUITING

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

fabiao zhang

Role: CONTACT

Phone: 13706760105

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

xiao liang

Role: primary

ning mu

Role: primary

Fabiao zhang

Role: primary

yunfeng Shan

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Richardson 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.

Reference Type BACKGROUND
PMID: 35978439 (View on PubMed)

Al-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.

Reference Type BACKGROUND
PMID: 35526333 (View on PubMed)

Bach 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.

Reference Type BACKGROUND
PMID: 31350294 (View on PubMed)

Liu 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.

Reference Type BACKGROUND
PMID: 35714833 (View on PubMed)

Onoyama 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.

Reference Type BACKGROUND
PMID: 29541466 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BileCAD-330

Identifier Type: -

Identifier Source: org_study_id