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Biliary Tract CarcinomaNCT05845554

Application of Chromosomal Instability in Early Diagnosis of Biliary Tract Carcinoma

An observational study of Biliary Tract Carcinoma, run by Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University at 4 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Carcinoma
What is being tested?
The extracted DNA from bile samples will be analyzed by BileCAD to determine the level of CIN.
How many people
300 participants
Where
4 sitesChina
Study dates
30 Mar 2023to 1 Apr 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

fabiao zhang contact

13706760105

zhangfabiao@enzemed.com

China4 sites, 4 recruiting

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

    Hangzhou, Zhejiang

    xiao liang, 13588708506, srrshlx@zju.edu.cn

    Recruiting

  • Taizhou First People's Hospital

    Taizhou, Zhejiang

    ning mu, 15105861595, mnwsq@163.com

    Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang

    Fabiao zhang, 13706760105, zhangfabiao@enzemed.com

    Recruiting

  • First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    yunfeng Shan, 13857763998, shanyunfeng@wmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Application of Chromosomal Instability and Metagenomic Detection in Early Diagnosis of Biliary Tract Carcinoma in Bile

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.

Read the detailed description

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.

Being tested
The extracted DNA from bile samples will be analyzed by BileCAD to determine the level of CIN.
Keywords
Biliary Tract Carcinoma, chromosomal instability
Medical subject headings
Chromosomal Instability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05845554
Study groupRoleWhat they receive
Biliary tract carcinoma patientsBiliary tract carcinoma patients will be the experimental group to determine the sensitivity of BileCAD analysis.
Receives: Diagnostic Test: The extracted DNA from bile samples will be analyzed by BileCAD to determine the level of CIN.
Non-cancer participants PatientsNon-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.
Receives: Diagnostic Test: The extracted DNA from bile samples will be analyzed by BileCAD to determine the level of CIN.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity of bile sample analysis by BileCADanalysis

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

    Measured: 12 months

  2. Specificity of bile sample analysis by BileCADanalysis

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

    Measured: 12 months

Secondary outcomes (2)

  1. BileCAD microbial analysis results

    Consistency of BileCAD microbial analysis results with clinical microbial culture results

    Measured: 12 months

  2. BileCAD analyzed the sensitivity of different types and locations of malignant tumors

    The tumors were classified into different types and sites and the sensitivity of BileCAD to different types and sites of malignant tumors was calculated.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start30 Mar 2023
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion1 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05845554
Sponsor's protocol ID
BileCAD-330
Status last verified
Dec 2023
First submitted
25 Apr 2023
Last updated
18 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35978439

  • 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.

    PubMed 35526333

  • 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.

    PubMed 31350294

  • 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.

    PubMed 35714833

  • 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.

    PubMed 29541466

Questions about this trial

What is this clinical trial studying?

An observational study of Biliary Tract Carcinoma, run by Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact fabiao zhang (13706760105, zhangfabiao@enzemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of bile sample analysis by BileCADanalysis (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05845554, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.

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