Liquid Biopsy Using Exosomal miRNA Enables Risk Stratification of Potential Metastasis in Patients With Intrahepatic Cholangiocarcinoma.
NCT ID: NCT07224737
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2024-06-21
2026-06-18
Brief Summary
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Detailed Description
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Preoperative exosomes will be analyzed using small RNA sequencing (discovery) followed by RT-qPCR validation and machine-learning modeling to develop a predictive score for occult metastasis. The study will evaluate diagnostic performance (sensitivity, specificity, accuracy, AUROC), prognostic relevance (OS/RFS), and clinical utility (decision curve analysis) to establish a biologically informed framework for treatment stratification in ICC.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Training Cohort - ICC without Occult Metastasis
The cohort of ICC patients without occult metastasis at the time of surgery. Preoperative samples were analyzed with the EXOMIC qRT-PCR assay to evaluate differential miRNA expression and refine the predictive model for occult metastasis detection.
EXOMIC assay (qRT-PCR validation)
Quantitative reverse transcription PCR (qRT-PCR)-based validation of candidate exosomal microRNAs identified through small RNA sequencing.
This assay was performed on preoperative serum or plasma samples from independent ICC patient cohorts to validate the predictive value of selected miRNAs for occult metastasis detection prior to surgical resection.
Validation Cohort - ICC with Occult Metastasis
The cohort of ICC patients with occult metastasis at the time of primary tumor resection.
The EXOMIC qRT-PCR assay was applied to confirm the predictive value of the exosomal miRNA panel in identifying occult metastasis prior to surgery.
EXOMIC assay (qRT-PCR validation)
Quantitative reverse transcription PCR (qRT-PCR)-based validation of candidate exosomal microRNAs identified through small RNA sequencing.
This assay was performed on preoperative serum or plasma samples from independent ICC patient cohorts to validate the predictive value of selected miRNAs for occult metastasis detection prior to surgical resection.
Validation Cohort - ICC without Occult Metastasis
The cohort of ICC patients without occult metastasis at the time of surgery. Preoperative samples were analyzed with the EXOMIC qRT-PCR assay to evaluate differential miRNA expression and refine the predictive model for occult metastasis detection.
EXOMIC assay (qRT-PCR validation)
Quantitative reverse transcription PCR (qRT-PCR)-based validation of candidate exosomal microRNAs identified through small RNA sequencing.
This assay was performed on preoperative serum or plasma samples from independent ICC patient cohorts to validate the predictive value of selected miRNAs for occult metastasis detection prior to surgical resection.
Discovery Cohort - ICC with Occult Metastasis
Patients with intrahepatic cholangiocarcinoma (ICC) who were found to have occult metastasis at the time of primary tumor resection in the discovery cohort.
Preoperative samples were analyzed using small RNA sequencing to identify exosome-derived microRNAs associated with the presence of occult metastasis.
EXOMIC small RNA sequencing
High-throughput small RNA sequencing performed on preoperative serum or plasma samples from patients with intrahepatic cholangiocarcinoma (ICC) to identify exosome-derived microRNAs associated with occult metastasis at the time of surgery.
Sequencing data were analyzed to detect differentially expressed miRNAs between patients with and without occult metastasis in the discovery cohort.
Discovery Cohort - ICC without Occult Metastasis
Patients with ICC who had no occult metastasis at the time of primary tumor resection in the discovery cohort.
Preoperative samples from these patients were analyzed by small RNA sequencing and compared with those from patients with occult metastasis to identify candidate microRNAs.
EXOMIC small RNA sequencing
High-throughput small RNA sequencing performed on preoperative serum or plasma samples from patients with intrahepatic cholangiocarcinoma (ICC) to identify exosome-derived microRNAs associated with occult metastasis at the time of surgery.
Sequencing data were analyzed to detect differentially expressed miRNAs between patients with and without occult metastasis in the discovery cohort.
Training Cohort - ICC with Occult Metastasis
The cohort of ICC patients who had occult metastasis detected at the time of surgery.
Preoperative samples were analyzed using the EXOMIC qRT-PCR assay to validate candidate exosomal microRNAs identified in the discovery cohort.
EXOMIC assay (qRT-PCR validation)
Quantitative reverse transcription PCR (qRT-PCR)-based validation of candidate exosomal microRNAs identified through small RNA sequencing.
This assay was performed on preoperative serum or plasma samples from independent ICC patient cohorts to validate the predictive value of selected miRNAs for occult metastasis detection prior to surgical resection.
Interventions
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EXOMIC small RNA sequencing
High-throughput small RNA sequencing performed on preoperative serum or plasma samples from patients with intrahepatic cholangiocarcinoma (ICC) to identify exosome-derived microRNAs associated with occult metastasis at the time of surgery.
Sequencing data were analyzed to detect differentially expressed miRNAs between patients with and without occult metastasis in the discovery cohort.
EXOMIC assay (qRT-PCR validation)
Quantitative reverse transcription PCR (qRT-PCR)-based validation of candidate exosomal microRNAs identified through small RNA sequencing.
This assay was performed on preoperative serum or plasma samples from independent ICC patient cohorts to validate the predictive value of selected miRNAs for occult metastasis detection prior to surgical resection.
Eligibility Criteria
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Inclusion Criteria
* Undergoing curative-intent hepatectomy.
* Availability of preoperative pasma or serum sample (≥200 µL).
* Standard staging imaging completed per institutional protocol.
* Written informed consent.
Exclusion Criteria
* Synchronous non-ICC malignancy.
* Inadequate clinical follow-up.
* Inability to consent.
18 Years
ALL
No
Sponsors
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City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Ajay Goel, PhD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Central Contacts
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Facility Contacts
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Ajay Goel, PhD
Role: primary
References
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Sirica AE, Strazzabosco M, Cadamuro M. Intrahepatic cholangiocarcinoma: Morpho-molecular pathology, tumor reactive microenvironment, and malignant progression. Adv Cancer Res. 2021;149:321-387. doi: 10.1016/bs.acr.2020.10.005. Epub 2020 Dec 9.
Fiste O, Ntanasis-Stathopoulos I, Gavriatopoulou M, Liontos M, Koutsoukos K, Dimopoulos MA, Zagouri F. The Emerging Role of Immunotherapy in Intrahepatic Cholangiocarcinoma. Vaccines (Basel). 2021 Apr 22;9(5):422. doi: 10.3390/vaccines9050422.
Clements O, Eliahoo J, Kim JU, Taylor-Robinson SD, Khan SA. Risk factors for intrahepatic and extrahepatic cholangiocarcinoma: A systematic review and meta-analysis. J Hepatol. 2020 Jan;72(1):95-103. doi: 10.1016/j.jhep.2019.09.007. Epub 2019 Sep 16.
Bertuccio P, Malvezzi M, Carioli G, Hashim D, Boffetta P, El-Serag HB, La Vecchia C, Negri E. Global trends in mortality from intrahepatic and extrahepatic cholangiocarcinoma. J Hepatol. 2019 Jul;71(1):104-114. doi: 10.1016/j.jhep.2019.03.013. Epub 2019 Mar 23.
An L, Zheng R, Zhang S, Chen R, Wang S, Sun K, Lu L, Zhang X, Zhao H, Zeng H, Wei W, He J. Hepatocellular carcinoma and intrahepatic cholangiocarcinoma incidence between 2006 and 2015 in China: estimates based on data from 188 population-based cancer registries. Hepatobiliary Surg Nutr. 2023 Feb 28;12(1):45-55. doi: 10.21037/hbsn-21-75. Epub 2021 Jul 21.
Huang G, Zhang H, Yang Z, Li Q, Yuan H, Chen P, Xie C, Meng B, Zhang X, Chen K, Yu H. Predictive value of HTS grade in patients with intrahepatic cholangiocarcinoma undergoing radical resection: a multicenter study from China. World J Surg Oncol. 2024 Jan 11;22(1):17. doi: 10.1186/s12957-023-03281-6.
Swanson K, Wu E, Zhang A, Alizadeh AA, Zou J. From patterns to patients: Advances in clinical machine learning for cancer diagnosis, prognosis, and treatment. Cell. 2023 Apr 13;186(8):1772-1791. doi: 10.1016/j.cell.2023.01.035. Epub 2023 Mar 10.
Kojima T, Umeda Y, Fuji T, Niguma T, Sato D, Endo Y, Sui K, Inagaki M, Oishi M, Ota T, Hioki K, Matsuda T, Aoki H, Hirai R, Kimura M, Yagi T, Fujiwara T. Efficacy of surgical management for recurrent intrahepatic cholangiocarcinoma: A multi-institutional study by the Okayama Study Group of HBP surgery. PLoS One. 2020 Sep 3;15(9):e0238392. doi: 10.1371/journal.pone.0238392. eCollection 2020.
Feng J, Liang B, Zhang HY, Liu Z, Jiang K, Zhao XQ. Prognostic factors for patients with mass-forming intrahepatic cholangiocarcinoma: A case series of 68 patients. World J Gastrointest Surg. 2022 May 27;14(5):442-451. doi: 10.4240/wjgs.v14.i5.442.
Doussot A, Gonen M, Wiggers JK, Groot-Koerkamp B, DeMatteo RP, Fuks D, Allen PJ, Farges O, Kingham TP, Regimbeau JM, D'Angelica MI, Azoulay D, Jarnagin WR. Recurrence Patterns and Disease-Free Survival after Resection of Intrahepatic Cholangiocarcinoma: Preoperative and Postoperative Prognostic Models. J Am Coll Surg. 2016 Sep;223(3):493-505.e2. doi: 10.1016/j.jamcollsurg.2016.05.019. Epub 2016 Jun 11.
Yu TH, Chen X, Zhang XH, Zhang EC, Sun CX. Clinicopathological characteristics and prognostic factors for intrahepatic cholangiocarcinoma: a population-based study. Sci Rep. 2021 Feb 17;11(1):3990. doi: 10.1038/s41598-021-83149-5.
Zhang R, Wang Z, Yang M, Chen B, Liu M, Zheng M, Liu PX, Wang L. Combining traditional analysis and machine learning to predict early, middle, and long-term recurrence of intrahepatic cholangiocarcinoma. Eur J Surg Oncol. 2025 Sep;51(9):110141. doi: 10.1016/j.ejso.2025.110141. Epub 2025 May 9.
Zhao B, Cheng Q, Cao H, Zhou X, Li T, Dong L, Wang W. Dynamic change of serum CA19-9 levels in benign and malignant patients with obstructive jaundice after biliary drainage and new correction formulas. BMC Cancer. 2021 May 7;21(1):517. doi: 10.1186/s12885-021-08204-w.
Other Identifiers
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23228/EXOMIC
Identifier Type: -
Identifier Source: org_study_id