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.
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
- Conditions the study is for
- Cholangiocarcinoma, Gallbladder Cancer and Extrahepatic Cholangiocarcinoma, Pancreatic Cancer
- 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
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.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200080
Xingdong Zheng, PhD, 86-021-63240090, shiyicss@126.com
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.
- Conditions
- Cholangiocarcinoma, Gallbladder Cancer and Extrahepatic Cholangiocarcinoma, Pancreatic Cancer, Bile Duct Strictures of Unknown Origin, Bile Duct Strictures
- 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 group | Role | What they receive |
|---|---|---|
| indeterminate biliary strictures | Pathologically 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.
Diagnostic sensitivity
Measured: histologically or cytogically confirmed , or followed up for 6 months
Secondary outcomes (5)
accuracy
Measured: histologically or cytologically confirmed or followed up for 6 months
Specificity
Measured: histologically or cytologically confirmed or followed up for 6 months
Positive predictive value,
Measured: histologically or cytologically confirmed or followed up for 6 months
negative predictive value
Measured: histologically or cytologically confirmed or followed up for 6 months
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.
- First posted6 Jun 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital, Shanghai 6th People's Hospital
- Responsible party
- Principal investigator, Xiaobo Cai, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xueying Ding, MD, Study chair, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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 32867043Arechederra 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 34285068Singhi 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 30971436de 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 32342216Platt 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 35287142Wang 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 35108222Korc 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 27156656Elmunzer 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 36863037Fujii-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