NCT05845554

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

April 25, 2023

Last Update Submit

December 15, 2023

Conditions

Biliary Tract Carcinoma

Keywords

Biliary Tract Carcinomachromosomal instability

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of bile sample analysis by BileCADanalysis

    Number of patients "declared positive" with the BileCAD test among the patients suffered from biliary tract carcinoma.

    12 months

  • Specificity of bile sample analysis by BileCADanalysis

    Number of patients "declared negative" with the BileCAD test among the patients without cancer.

    12 months

Secondary Outcomes (2)

  • BileCAD microbial analysis results

    12 months

  • BileCAD analyzed the sensitivity of different types and locations of malignant tumors

    12 months

Study Arms (2)

Biliary tract carcinoma patients

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

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

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.

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

Interventions

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

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

Biliary tract carcinoma patientsNon-cancer participants Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with biliary tract carcinoma or participants in control group in Taizhou Hospital of Zhejiang Province, Taizhou First People's Hospital, The First Affiliated Hospital of Wenzhou Medical University and Sir Run Run Shaw Hospital from Apr 2023 until the end of this study.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Hangzhou, Zhejiang, China

RECRUITING

Taizhou First People's Hospital

Taizhou, Zhejiang, China

RECRUITING

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

RECRUITING

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 35978439BACKGROUND

  • 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.

    PMID: 35526333BACKGROUND

  • 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.

    PMID: 31350294BACKGROUND

  • 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.

    PMID: 35714833BACKGROUND

  • 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.

    PMID: 29541466BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA from cast-off cells in bile sample

MeSH Terms

Conditions

Chromosomal Instability

Condition Hierarchy (Ancestors)

Chromosome AberrationsPathologic ProcessesPathological Conditions, Signs and SymptomsGenomic Instability

Study Officials

  • fabiao zhang

    Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

  • yunfeng shan

    First Affiliated Hospital of Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

  • ning mu

    Taizhou First People's Hospital

    PRINCIPAL INVESTIGATOR

  • xiao liang

    Sir Run Run Shaw Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

fabiao zhang

CONTACT

13706760105zhangfabiao@enzemed.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
department director

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 6, 2023

Study Start

March 30, 2023

Primary Completion

December 30, 2023

Study Completion

April 1, 2024

Last Updated

December 18, 2023

Record last verified: 2023-12

Locations

CN(4)