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Bile Duct NeoplasmsNCT06115655

A Single-center, Prospective Cohort Study on the Differentiation of Benign and Malignant Bile Duct Stenosis Based on Bile and Peripheral Blood cfDNA Methylation Profiles

An observational study of Bile Duct Neoplasms and Jaundice, Obstructive, run by Air Force Military Medical University, China at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The goal of this observational study is to detect the methylation characteristics of cfDNA in the bile and plasma of patients with bile duct stricture. The main question it aims to answer is: Can the developed model, using peripheral blood and bile cell-free DNA sequencing, work well in screening and classifying… Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
What is being tested?
cfDNA methylation detection
How many people
161 participants
Where
1 siteChina
Study dates
1 Oct 2023to 30 Oct 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 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: According to the "Sample Size Calculation for Comparative Diagnostic Studies with Categorical Variables (Rates)" method, it is calculated. Based on the previous research results, it is estimated that the diagnostic sensitivity of sequencing methylation profiles in bile cfDNA is 82%, the specificity is 95%, the allowable error in sensitivity is 0.1, the allowable error in specificity is 0.1, α is set to 0.05, the loss to follow-up rate is 10%, and the calculated sample size is approximately 161 cases.

Who may be able to join

  • 1. Patients with biliary stricture aged between 18 and 90 years old.
  • 2. Patients scheduled to undergo ERCP surgery due to obstructive jaundice or cholangitis.
  • 3. Definite benign or malignant diagnosis: with a pathological diagnosis of benign or malignant disease, or with follow-up data indicating a benign or malignant diagnosis.

Who cannot join

  • 1. Receive radiotherapy, chemotherapy, or targeted therapy before sampling.
  • 2. Malignant tumors in other parts of the body (not related to biliary stricture).
  • 3. Unable to determine the nature of the biliary stricture.
  • 4. Ineligible for ERCP due to systemic conditions or gastrointestinal obstruction.
  • 5. Pregnant or breastfeeding women.
  • 6. Unable to sign the informed consent form.

Trial locations and contacts

1 site in 1 country.

Yanglin Pan, MD contact

+86-13991811225

panyl@fmmu.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital of the Air Force Medical University

    Xi'an, Shaanxi, 710032

    Yanglin Pan, +86-13991811225, panyl@fmmu.edu.cn

    Recruiting

Other trials in China

About this study

The goal of this observational study is to detect the methylation characteristics of cfDNA in the bile and plasma of patients with bile duct stricture. The main question it aims to answer is: Can the developed model, using peripheral blood and bile cell-free DNA sequencing, work well in screening and classifying unknown biliary stricture? Participants will collect approximately 10ml of peripheral blood and 5ml of bile from the patient.

Being tested
cfDNA methylation detection
Keywords
Methylation, Liquid Biopsy, Cell-Free Nucleic Acids, Cancer Diagnosis
Medical subject headings
Bile Duct Neoplasms, Jaundice, Obstructive, Bile Duct Diseases

What participants receive

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

  • cfDNA methylation detectionDiagnostic test

    Extract cfDNA from bile and plasma, and perform methylation detection.

Study groups in NCT06115655
Study groupRoleWhat they receive
malignant patientsThe presence of biliary stricture due to malignant diseases, such as cholangiocarcinoma.
Receives: Diagnostic Test: cfDNA methylation detection
benign patientsThe presence of biliary stricture due to benign diseases, such as inflammation.
Receives: Diagnostic Test: cfDNA methylation detection

What is being measured

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

  1. Diagnostic accuracy

    This refers to the ability of the test (cell-free DNA sequencing) to correctly classify individuals into the categories of having or not having the disease. It is a measure of the test's overall effectiveness. The reference test is histological test for cancers or one-year follow-up for non-cancers.

    Measured: Immediately after test completion

  2. Sensitivity

    This is the ability of the test (cell-free DNA sequencing) to correctly identify those with the disease. It is the proportion of true positive results (those with the disease who test positive) to the total number of individuals who actually have the disease. The reference test is histological test for cancers or one-year follow-up for non-cancers.

    Measured: Immediately after test completion

  3. Specificity

    This is the ability of the test (cell-free DNA sequencing) to correctly identify those without disease. It is the proportion of true negative results (those without the disease who test negative) to the total number of individuals who actually do not have the disease. The reference test is histological test for cancers or one-year follow-up for non-cancers.

    Measured: Immediately after test completion

Timeline

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

  1. First posted3 Nov 2023
  2. Study start1 Oct 2023
  3. Primary completion1 Oct 2024 (estimated)
  4. Study completion30 Oct 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
Cohort
Time perspective
Prospective
Enrolment
161 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06115655
Sponsor's protocol ID
KY20232312
Status last verified
Oct 2023
First submitted
30 Oct 2023
Last updated
3 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dorrell R, Pawa S, Zhou Y, Lalwani N, Pawa R. The Diagnostic Dilemma of Malignant Biliary Strictures. Diagnostics (Basel). 2020 May 25;10(5):337. doi: 10.3390/diagnostics10050337.

    PubMed 32466095

  • Dumonceau JM, Delhaye M, Charette N, Farina A. Challenging biliary strictures: pathophysiological features, differential diagnosis, diagnostic algorithms, and new clinically relevant biomarkers - part 1. Ther Adv Gastroenterol. 2020 Jun 16;13:1756284820927292. doi: 10.1177/1756284820927292. eCollection 2020.

    PubMed 32595761

  • Sun B, Moon JH, Cai Q, Rerknimitr R, Ma S, Lakhtakia S, Ryozawa S, Kutsumi H, Yasuda I, Shiomi H, Li X, Li W, Zhang X, Itoi T, Wang HP, Qian D, Wong Lau JY, Yang Z, Ji M, Hu B; Asia-Pacific ERCP Club. Review article: Asia-Pacific consensus recommendations on endoscopic tissue acquisition for biliary strictures. Aliment Pharmacol Ther. 2018 Jul;48(2):138-151. doi: 10.1111/apt.14811. Epub 2018 Jun 7.

    PubMed 29876948

  • Davalos V, Esteller M. Cancer epigenetics in clinical practice. CA Cancer J Clin. 2023 Jul-Aug;73(4):376-424. doi: 10.3322/caac.21765. Epub 2022 Dec 13.

    PubMed 36512337

  • Vedeld HM, Grimsrud MM, Andresen K, Pharo HD, von Seth E, Karlsen TH, Honne H, Paulsen V, Farkkila MA, Bergquist A, Jeanmougin M, Aabakken L, Boberg KM, Folseraas T, Lind GE. Early and accurate detection of cholangiocarcinoma in patients with primary sclerosing cholangitis by methylation markers in bile. Hepatology. 2022 Jan;75(1):59-73. doi: 10.1002/hep.32125. Epub 2021 Dec 5.

    PubMed 34435693

  • Goeppert B, Stichel D, Toth R, Fritzsche S, Loeffler MA, Schlitter AM, Neumann O, Assenov Y, Vogel MN, Mehrabi A, Hoffmann K, Kohler B, Springfeld C, Weichenhan D, Plass C, Esposito I, Schirmacher P, von Deimling A, Roessler S. Integrative analysis reveals early and distinct genetic and epigenetic changes in intraductal papillary and tubulopapillary cholangiocarcinogenesis. Gut. 2022 Feb;71(2):391-401. doi: 10.1136/gutjnl-2020-322983. Epub 2021 Jan 19.

    PubMed 33468537

  • Colyn L, Barcena-Varela M, Alvarez-Sola G, Latasa MU, Uriarte I, Santamaria E, Herranz JM, Santos-Laso A, Arechederra M, Ruiz de Gauna M, Aspichueta P, Canale M, Casadei-Gardini A, Francesconi M, Carotti S, Morini S, Nelson LJ, Iraburu MJ, Chen C, Sangro B, Marin JJG, Martinez-Chantar ML, Banales JM, Arnes-Benito R, Huch M, Patino JM, Dar AA, Nosrati M, Oyarzabal J, Prosper F, Urman J, Cubero FJ, Trautwein C, Berasain C, Fernandez-Barrena MG, Avila MA. Dual Targeting of G9a and DNA Methyltransferase-1 for the Treatment of Experimental Cholangiocarcinoma. Hepatology. 2021 Jun;73(6):2380-2396. doi: 10.1002/hep.31642.

    PubMed 33222246

Questions about this trial

What is this clinical trial studying?

An observational study of Bile Duct Neoplasms and Jaundice, Obstructive, run by Air Force Military Medical University, China at 1 site 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 3 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 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Yanglin Pan, MD (+86-13991811225, panyl@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy (time frame: Immediately after test completion). The study lists 3 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 NCT06115655, which also lists 7 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 3 Nov 2023.

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