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AzTrials

CholangiocarcinomaNCT07007832

Bile Omics for Diagnosing Indeterminate Biliary Strictures

An observational study of Cholangiocarcinoma and Gallbladder Cancer and Extrahepatic Cholangiocarcinoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The diagnosis of malignant biliary strictures remains a challenging aspect of biliary endoscopy. Molecular biological testing techniques based on bile have been reported to improve detection rates. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Endoscopic retrograde cholangiopancreatography
Type of treatment
Surgery or procedure
How many people
260 participants
Where
1 siteChina
Study dates
1 Jan 2024to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients hospitalized in top-tier academic medical center in Shanghai, China (Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; The Third Affiliated Hospital of Naval Medical University; Shanghai Sixth People's Hospital, Shanghai Jiao Tong University School of Medicine)

Who may be able to join

  • Indeterminate biliary strictures
  • Aged 18-90 years
  • Underwent ERCP with biliary biopsy and/or brush cytology

Who cannot join

  • Coagulation disorders
  • Pregnancy
  • Malignancies of other organs unrelated to biliary strictures
  • Declined participation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaobo Cai, MD contact

86+13918177123

caixiaobo1979@hotmail.com

China1 site, 1 recruiting

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, China, 200080

    Xingdong Zheng, PhD, 86-021-63240090, shiyicss@126.com

    Recruiting

Other trials in China

About this study

Official title: The Diagnostic Value of Bile-based Omics Analysis for Indeterminate Biliary Strictures

The diagnosis of malignant biliary strictures remains a challenging aspect of biliary endoscopy. Molecular biological testing techniques based on bile have been reported to improve detection rates. However, whether the combination of bile-based omics studies and biliary brush cytology/biopsy can enhance diagnostic sensitivity has not yet been reported. This study aims to collect bile from patients with malignant biliary strictures, screen for molecular markers associated with biliary malignancies through multi-omics analysis, and subsequently validate these markers to establish a bile-based molecular diagnostic model.

Being tested
Endoscopic retrograde cholangiopancreatography
Medical subject headings
Cholangiocarcinoma, Gallbladder Neoplasms, Pancreatic Neoplasms

What participants receive

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

  • Endoscopic retrograde cholangiopancreatographyProcedure or surgery

    Also called biliary brush cytology, biopsy

    Since patients with biliary strictures almost universally require endoscopic biliary interventions for both diagnostic and drainage purposes, bile aspiration can be readily obtained during these procedures, facilitating subsequent analyses. However, proteomic and metabolomic profiling of bile in malignant biliary strictures remains unreported to date. This study aims to evaluate the diagnostic value of combining bile proteomics/metabolomics with biliary brush cytology/biopsy for malignant biliary strictures, while also providing evidence for identifying potential biomarkers.

Study groups in NCT07007832
Study groupRoleWhat they receive
indeterminate biliary stricturesPathologically or clinical confirmed
Receives: Procedure: Endoscopic retrograde cholangiopancreatography

What is being measured

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

  1. Diagnostic sensitivity

    Measured: histologically or cytogically confirmed , or followed up for 6 months

Secondary outcomes (5)

  1. accuracy

    Measured: histologically or cytologically confirmed or followed up for 6 months

  2. Specificity

    Measured: histologically or cytologically confirmed or followed up for 6 months

  3. Positive predictive value,

    Measured: histologically or cytologically confirmed or followed up for 6 months

  4. negative predictive value

    Measured: histologically or cytologically confirmed or followed up for 6 months

  5. AUC area (histologically or cytologically confirmed or followed up for 6 months)

    Measured: up for 6 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 Jun 2025
  2. Study start1 Jan 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (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
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07007832
Sponsor's protocol ID
[2025] No. 236
Status last verified
Jun 2025
First submitted
29 May 2025
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We plan to share de-identified IPD upon reasonable request after publication, contingent on approval from our institutional ethics committee. Data availability will be subject to a formal data use agreement to ensure patient confidentiality and compliance with local regulations. Restrictions may apply to protect participant privacy given the sensitive nature of clinical biliary data.

Publications

  • Bhawal R, Oberg AL, Zhang S, Kohli M. Challenges and Opportunities in Clinical Applications of Blood-Based Proteomics in Cancer. Cancers (Basel). 2020 Aug 27;12(9):2428. doi: 10.3390/cancers12092428.

    PubMed 32867043

  • Arechederra M, Rullan M, Amat I, Oyon D, Zabalza L, Elizalde M, Latasa MU, Mercado MR, Ruiz-Clavijo D, Saldana C, Fernandez-Urien I, Carrascosa J, Jusue V, Guerrero-Setas D, Zazpe C, Gonzalez-Borja I, Sangro B, Herranz JM, Purroy A, Gil I, Nelson LJ, Vila JJ, Krawczyk M, Zieniewicz K, Patkowski W, Milkiewicz P, Cubero FJ, Alkorta-Aranburu G, G Fernandez-Barrena M, Urman JM, Berasain C, Avila MA. Next-generation sequencing of bile cell-free DNA for the early detection of patients with malignant biliary strictures. Gut. 2022 Jun;71(6):1141-1151. doi: 10.1136/gutjnl-2021-325178. Epub 2021 Jul 20.

    PubMed 34285068

  • Singhi AD, Nikiforova MN, Chennat J, Papachristou GI, Khalid A, Rabinovitz M, Das R, Sarkaria S, Ayasso MS, Wald AI, Monaco SE, Nalesnik M, Ohori NP, Geller D, Tsung A, Zureikat AH, Zeh H, Marsh JW, Hogg M, Lee K, Bartlett DL, Pingpank JF, Humar A, Bahary N, Dasyam AK, Brand R, Fasanella KE, McGrath K, Slivka A. Integrating next-generation sequencing to endoscopic retrograde cholangiopancreatography (ERCP)-obtained biliary specimens improves the detection and management of patients with malignant bile duct strictures. Gut. 2020 Jan;69(1):52-61. doi: 10.1136/gutjnl-2018-317817. Epub 2019 Apr 10.

    PubMed 30971436

  • de Oliveira PVAG, de Moura DTH, Ribeiro IB, Bazarbashi AN, Franzini TAP, Dos Santos MEL, Bernardo WM, de Moura EGH. Efficacy of digital single-operator cholangioscopy in the visual interpretation of indeterminate biliary strictures: a systematic review and meta-analysis. Surg Endosc. 2020 Aug;34(8):3321-3329. doi: 10.1007/s00464-020-07583-8. Epub 2020 Apr 27.

    PubMed 32342216

  • Platt KD, Schulman AR. Increasing the Yield: When More Is Better. Am J Gastroenterol. 2022 May 1;117(5):729-730. doi: 10.14309/ajg.0000000000001724. Epub 2022 Mar 14.

    PubMed 35287142

  • Wang J, Xia M, Jin Y, Zheng H, Shen Z, Dai W, Li X, Kang M, Wan R, Lu L, Hu B, Wan X, Cai X. More Endoscopy-Based Brushing Passes Improve the Detection of Malignant Biliary Strictures: A Multicenter Randomized Controlled Trial. Am J Gastroenterol. 2022 May 1;117(5):733-739. doi: 10.14309/ajg.0000000000001666. Epub 2022 Feb 2.

    PubMed 35108222

  • Korc P, Sherman S. ERCP tissue sampling. Gastrointest Endosc. 2016 Oct;84(4):557-71. doi: 10.1016/j.gie.2016.04.039. Epub 2016 May 6. No abstract available.

    PubMed 27156656

  • Elmunzer BJ, Maranki JL, Gomez V, Tavakkoli A, Sauer BG, Limketkai BN, Brennan EA, Attridge EM, Brigham TJ, Wang AY. ACG Clinical Guideline: Diagnosis and Management of Biliary Strictures. Am J Gastroenterol. 2023 Mar 1;118(3):405-426. doi: 10.14309/ajg.0000000000002190. Epub 2023 Jan 17.

    PubMed 36863037

  • Fujii-Lau LL, Thosani NC, Al-Haddad M, Acoba J, Wray CJ, Zvavanjanja R, Amateau SK, Buxbaum JL, Wani S, Calderwood AH, Chalhoub JM, Coelho-Prabhu N, Desai M, Elhanafi SE, Fishman DS, Forbes N, Jamil LH, Jue TL, Kohli DR, Kwon RS, Law JK, Lee JK, Machicado JD, Marya NB, Pawa S, Ruan W, Sawhney MS, Sheth SG, Storm A, Thiruvengadam NR, Qumseya BJ; (ASGE Standards of Practice Committee Chair [2020-2023]). American Society for Gastrointestinal Endoscopy guideline on role of endoscopy in the diagnosis of malignancy in biliary strictures of undetermined etiology: methodology and review of evidence. Gastrointest Endosc. 2023 Nov;98(5):694-712.e8. doi: 10.1016/j.gie.2023.06.007. Epub 2023 Jun 10.

    PubMed 37307901

Questions about this trial

What is this clinical trial studying?

An observational study of Cholangiocarcinoma and Gallbladder Cancer and Extrahepatic Cholangiocarcinoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 4 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: looking for participants now, as of the sponsor's last update on 11 Jun 2025. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Xiaobo Cai, MD (86+13918177123, caixiaobo1979@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic sensitivity (time frame: histologically or cytogically confirmed , or followed up for 6 months). 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 NCT07007832, which also lists 9 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 11 Jun 2025.

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