CholangiocarcinomaLyMICNCT06381648
Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma (LyMIC)
An observational study of Cholangiocarcinoma and Cholangiocarcinoma, Intrahepatic, run by City of Hope Medical Center at 4 sites in 2 countries.
Trial summary
Lymph node metastasis (LNM) is a major prognostic factor in intrahepatic cholangiocarcinoma (ICC), and accurate preoperative prediction of the presence or absence of LNM has significant clinical implications in determining treatment strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma Resectable
- What is being tested?
- LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma)
- How many people
- 230 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 15 Apr 2023to 1 Jul 2025
- 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: Individuals who were diagnosed with Intrahepatic cholangiocarcinoma
Who may be able to join
- A histologically confirmed diagnosis of intrahepatic cholangiocarcinoma.
- Received standard diagnostic and staging procedures as per local guidelines
- Availability of at least one blood-derived sample, drawn before receiving any curative-intent treatment
Who cannot join
- Lack of or inability to provide informed consent
- Synchronous Intrahepatic cholangiocarcinoma and non- Intrahepatic cholangiocarcinoma diagnosed at or before surgery
- Secondary liver cancer
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Japan3 sites
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University
Fukuoka, 812-8582
Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University
Hokkaido, Sapporo, 060-8648
Department of Surgery, Tokushima University
Tokushima, 770-8503
United States1 site
City of Hope Medical Center
Duarte, California, 91016
About this study
Official title: An Exosome-based Liquid Biopsy Signature for Pre-operative Identification of Lymph Node Metastasis in Patients With Intrahepatic Cholangiocarcinoma
Lymph node metastasis (LNM) is a major prognostic factor in intrahepatic cholangiocarcinoma (ICC), and accurate preoperative prediction of the presence or absence of LNM has significant clinical implications in determining treatment strategy. Despite this, there are currently no reliable biomarkers established to detect LNM in ICC.
This study seeks to develop a liquid biopsy assay that can accurately detect LNM before treatment in ICC patients.
Read the detailed description
Intrahepatic cholangiocarcinoma (ICC) is a malignant tumor of the liver arising from epithelial cells of the biliary tract, accounting for 10-15% of primary liver cancers, and the incidence of ICC has increased rapidly worldwide over the past decade. The long-term prognosis is dismal, with a 5-year overall survival (OS) as low as 25-30%. Many studies have highlighted lymph node metastasis as a strong predictor of poor prognosis in ICC patients, prompting efforts such as appropriate lymphadenectomy to accurately predict disease stage and reduce outcomes associated with LNM. Adequate lymphadenectomy in patients with suspected LNM is essential for achieving R0 resection and is a necessary component of complete cure and long-term survival. The routine use of highly invasive lymphadenectomy in all patients remains controversial, and lymphadenectomy rates for ICC range from 26.9% to 100% depending on the literature and are not universally adopted currently.
Currently, LNM is detected preoperatively by imaging, but imaging alone is not sufficient to diagnose LNM, as negative findings by imaging findings may have low sensitivity and may not rule out LNM. Other attempts have been made to develop predictive scoring systems based on Carbohydrate antigen 19-9 (CA 19-9) levels, location of the primary tumor, lymph node patterns on CT and MRI, and other clinical factors to predict LNM in ICC, but all these predictive systems rely heavily on judgment regarding lymph node size and tumor growth patterns are largely left to diagnostic imaging.
This study seeks to validate a panel of more accurate and non-invasive biomarkers (exo-miRNAs) in preoperative blood samples. Accurate preoperative detection of the presence of LNM would help provide clear criteria for ICC treatment decisions, such as the implementation of elective lymphadenectomy or the addition of chemotherapy.
- Conditions
- Cholangiocarcinoma, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma Resectable, Cholangiocarcinoma; Liver
- Being tested
- LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma)
- Keywords
- Intrahepatic cholangiocarcinoma, Exosome, micro-RNA, Liquid biopsy, Blood test, Lymph node metastasis, Lymph node dissection, Lymphadenectomy
- Medical subject headings
- Cholangiocarcinoma, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma)Diagnostic test
A panel of exosomal miRNAs, whose expression levels are tested in serum or plasma samples collected prior to primary tumor resection, with reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR)
| Study group | Role | What they receive |
|---|---|---|
| Intrahepatic Cholangiocarcinoma, With Lymph node metastasis (Training) | Patients with ICC who had lymph node metastases at the time of primary tumor treatment with D2 dissection, in the first cohort. Receives: Diagnostic Test: LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma) | |
| Intrahepatic Cholangiocarcinoma, Without Lymph node metastasis (Training) | Patients with ICC who did not have lymph node metastases at the time of primary tumor treatment with D2 dissection, in the first cohort. Receives: Diagnostic Test: LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma) | |
| Intrahepatic Cholangiocarcinoma, With Lymph node metastasis (Validation) | Patients with ICC who had lymph node metastases at the time of primary tumor treatment with D2 dissection, in the second cohort. Receives: Diagnostic Test: LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma) | |
| Intrahepatic Cholangiocarcinoma, Without Lymph node metastasis (Validation) | Patients with ICC who did not have lymph node metastases at the time of primary tumor treatment with D2 dissection, in the second cohort. Receives: Diagnostic Test: LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
True Positive Rate: the probability of a positive test result, conditioned on the individual truly being positive
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Specificity
True Negative Rate: the probability of a negative test result, conditioned on the individual truly being negative
Measured: Through study completion, an average of 1 year
Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy)
A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start15 Apr 2023
- Primary completion1 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ajay Goel, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381648
- Sponsor's protocol ID
- 23228/LyMIC
- Acronym
- LyMIC
- Status last verified
- Mar 2026
- First submitted
- 19 Apr 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data
Publications
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Aljiffry M, Abdulelah A, Walsh M, Peltekian K, Alwayn I, Molinari M. Evidence-based approach to cholangiocarcinoma: a systematic review of the current literature. J Am Coll Surg. 2009 Jan;208(1):134-47. doi: 10.1016/j.jamcollsurg.2008.09.007. Epub 2008 Oct 31. No abstract available.
PubMed 19228515Clements 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.
PubMed 31536748Van Dyke AL, Shiels MS, Jones GS, Pfeiffer RM, Petrick JL, Beebe-Dimmer JL, Koshiol J. Biliary tract cancer incidence and trends in the United States by demographic group, 1999-2013. Cancer. 2019 May 1;125(9):1489-1498. doi: 10.1002/cncr.31942. Epub 2019 Jan 15.
PubMed 30645774Guglielmi A, Ruzzenente A, Campagnaro T, Pachera S, Valdegamberi A, Nicoli P, Cappellani A, Malfermoni G, Iacono C. Intrahepatic cholangiocarcinoma: prognostic factors after surgical resection. World J Surg. 2009 Jun;33(6):1247-54. doi: 10.1007/s00268-009-9970-0.
PubMed 19294467Berretta M, Cavaliere C, Alessandrini L, Stanzione B, Facchini G, Balestreri L, Perin T, Canzonieri V. Serum and tissue markers in hepatocellular carcinoma and cholangiocarcinoma: clinical and prognostic implications. Oncotarget. 2017 Feb 21;8(8):14192-14220. doi: 10.18632/oncotarget.13929.
PubMed 28077782Altman AM, Kizy S, Marmor S, Huang JL, Denbo JW, Jensen EH. Current survival and treatment trends for surgically resected intrahepatic cholangiocarcinoma in the United States. J Gastrointest Oncol. 2018 Oct;9(5):942-952. doi: 10.21037/jgo.2017.11.06.
PubMed 30505597Bartsch F, Hahn F, Muller L, Baumgart J, Hoppe-Lotichius M, Kloeckner R, Lang H. Relevance of suspicious lymph nodes in preoperative imaging for resectability, recurrence and survival of intrahepatic cholangiocarcinoma. BMC Surg. 2020 Apr 15;20(1):75. doi: 10.1186/s12893-020-00730-x.
PubMed 32295646Dodson RM, Weiss MJ, Cosgrove D, Herman JM, Kamel I, Anders R, Geschwind JF, Pawlik TM. Intrahepatic cholangiocarcinoma: management options and emerging therapies. J Am Coll Surg. 2013 Oct;217(4):736-750.e4. doi: 10.1016/j.jamcollsurg.2013.05.021. Epub 2013 Jul 24. No abstract available.
PubMed 23890842de Jong MC, Nathan H, Sotiropoulos GC, Paul A, Alexandrescu S, Marques H, Pulitano C, Barroso E, Clary BM, Aldrighetti L, Ferrone CR, Zhu AX, Bauer TW, Walters DM, Gamblin TC, Nguyen KT, Turley R, Popescu I, Hubert C, Meyer S, Schulick RD, Choti MA, Gigot JF, Mentha G, Pawlik TM. Intrahepatic cholangiocarcinoma: an international multi-institutional analysis of prognostic factors and lymph node assessment. J Clin Oncol. 2011 Aug 10;29(23):3140-5. doi: 10.1200/JCO.2011.35.6519. Epub 2011 Jul 5.
PubMed 21730269Cambridge WA, Fairfield C, Powell JJ, Harrison EM, Soreide K, Wigmore SJ, Guest RV. Meta-analysis and Meta-regression of Survival After Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma. Ann Surg. 2021 Feb 1;273(2):240-250. doi: 10.1097/SLA.0000000000003801.
PubMed 32097164Brindley PJ, Bachini M, Ilyas SI, Khan SA, Loukas A, Sirica AE, Teh BT, Wongkham S, Gores GJ. Cholangiocarcinoma. Nat Rev Dis Primers. 2021 Sep 9;7(1):65. doi: 10.1038/s41572-021-00300-2.
PubMed 34504109Sposito C, Ratti F, Cucchetti A, Ardito F, Ruzzenente A, Di Sandro S, Maspero M, Ercolani G, Di Benedetto F, Guglielmi A, Giuliante F, Aldrighetti L, Mazzaferro V. Survival benefit of adequate lymphadenectomy in patients undergoing liver resection for clinically node-negative intrahepatic cholangiocarcinoma. J Hepatol. 2023 Feb;78(2):356-363. doi: 10.1016/j.jhep.2022.10.021. Epub 2022 Oct 31.
PubMed 36328332Bridgewater J, Galle PR, Khan SA, Llovet JM, Park JW, Patel T, Pawlik TM, Gores GJ. Guidelines for the diagnosis and management of intrahepatic cholangiocarcinoma. J Hepatol. 2014 Jun;60(6):1268-89. doi: 10.1016/j.jhep.2014.01.021. Epub 2014 Mar 27. No abstract available.
PubMed 24681130Deane MP, Jansen AM. From a mono to a digenetic life-cycle: how was the jump for flagellates of the family Trypanosomatidae? Mem Inst Oswaldo Cruz. 1988 Jul-Sep;83(3):273-5. doi: 10.1590/s0074-02761988000300002.
PubMed 3152272
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exosome-based Liquid Biopsy Signature for Pre-operative Identification of Lymph Node Metastasis in Patients With Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT06381648
- Acronym / sponsor ID
- LyMIC / 23228/LyMIC
- Conditions
- Cholangiocarcinoma, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma Resectable, Cholangiocarcinoma; Liver
- Keywords
- Intrahepatic cholangiocarcinoma, Exosome, micro-RNA, Liquid biopsy, Blood test, Lymph node metastasis, Lymph node dissection, Lymphadenectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lymph node metastasis (LNM) is a major prognostic factor in intrahepatic cholangiocarcinoma (ICC), and accurate preoperative prediction of the presence or absence of LNM has significant clinical implications in determining treatment strategy. Despite this, there are currently no reliable biomarkers established to detect LNM in ICC.
This study seeks to develop a liquid biopsy assay that can accurately detect LNM before treatment in ICC patients.
Detailed description
Intrahepatic cholangiocarcinoma (ICC) is a malignant tumor of the liver arising from epithelial cells of the biliary tract, accounting for 10-15% of primary liver cancers, and the incidence of ICC has increased rapidly worldwide over the past decade. The long-term prognosis is dismal, with a 5-year overall survival (OS) as low as 25-30%. Many studies have highlighted lymph node metastasis as a strong predictor of poor prognosis in ICC patients, prompting efforts such as appropriate lymphadenectomy to accurately predict disease stage and reduce outcomes associated with LNM. Adequate lymphadenectomy in patients with suspected LNM is essential for achieving R0 resection and is a necessary component of complete cure and long-term survival. The routine use of highly invasive lymphadenectomy in all patients remains controversial, and lymphadenectomy rates for ICC range from 26.9% to 100% depending on the literature and are not universally adopted currently.
Currently, LNM is detected preoperatively by imaging, but imaging alone is not sufficient to diagnose LNM, as negative findings by imaging findings may have low sensitivity and may not rule out LNM. Other attempts have been made to develop predictive scoring systems based on Carbohydrate antigen 19-9 (CA 19-9) levels, location of the primary tumor, lymph node patterns on CT and MRI, and other clinical factors to predict LNM in ICC, but all these predictive systems rely heavily on judgment regarding lymph node size and tumor growth patterns are largely left to diagnostic imaging.
This study seeks to validate a panel of more accurate and non-invasive biomarkers (exo-miRNAs) in preoperative blood samples. Accurate preoperative detection of the presence of LNM would help provide clear criteria for ICC treatment decisions, such as the implementation of elective lymphadenectomy or the addition of chemotherapy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intrahepatic Cholangiocarcinoma, With Lymph node metastasis (Training) | – | Diagnostic Test: LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma)Patients with ICC who had lymph node metastases at the time of primary tumor treatment with D2 dissection, in the first cohort. |
| Intrahepatic Cholangiocarcinoma, Without Lymph node metastasis (Training) | – | Diagnostic Test: LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma)Patients with ICC who did not have lymph node metastases at the time of primary tumor treatment with D2 dissection, in the first cohort. |
| Intrahepatic Cholangiocarcinoma, With Lymph node metastasis (Validation) | – | Diagnostic Test: LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma)Patients with ICC who had lymph node metastases at the time of primary tumor treatment with D2 dissection, in the second cohort. |
| Intrahepatic Cholangiocarcinoma, Without Lymph node metastasis (Validation) | – | Diagnostic Test: LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma)Patients with ICC who did not have lymph node metastases at the time of primary tumor treatment with D2 dissection, in the second cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who were diagnosed with Intrahepatic cholangiocarcinoma
Key inclusion criteria (3 listed)
- A histologically confirmed diagnosis of intrahepatic cholangiocarcinoma.
- Received standard diagnostic and staging procedures as per local guidelines
- Availability of at least one blood-derived sample, drawn before receiving any curative-intent treatment
Key exclusion criteria (3 listed)
- Lack of or inability to provide informed consent
- Synchronous Intrahepatic cholangiocarcinoma and non- Intrahepatic cholangiocarcinoma diagnosed at or before surgery
- Secondary liver cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma)A panel of exosomal miRNAs, whose expression levels are tested in serum or plasma samples collected prior to primary tumor resection, with reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) | Diagnostic test | Intrahepatic Cholangiocarcinoma, With Lymph node metastasis (Training), Intrahepatic Cholangiocarcinoma, With Lymph node metastasis (Validation), Intrahepatic Cholangiocarcinoma, Without Lymph node metastasis (Training), Intrahepatic Cholangiocarcinoma, Without Lymph node metastasis (Validation) |
Primary outcome
Sensitivity
Time frame: Through study completion, an average of 1 year
True Positive Rate: the probability of a positive test result, conditioned on the individual truly being positive
2 secondary outcomes
Specificity
Time frame: Through study completion, an average of 1 year
Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy)
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 19228515Aljiffry M, Abdulelah A, Walsh M, Peltekian K, Alwayn I, Molinari M. Evidence-based approach to cholangiocarcinoma: a systematic review of the current literature. J Am Coll Surg. 2009 Jan;208(1):134-47. doi: 10.1016/j.jamcollsurg.2008.09.007. Epub 2008 Oct 31. No abstract available.
- Background: PubMed 31536748Clements 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.
- Background: PubMed 30645774Van Dyke AL, Shiels MS, Jones GS, Pfeiffer RM, Petrick JL, Beebe-Dimmer JL, Koshiol J. Biliary tract cancer incidence and trends in the United States by demographic group, 1999-2013. Cancer. 2019 May 1;125(9):1489-1498. doi: 10.1002/cncr.31942. Epub 2019 Jan 15.
- Background: PubMed 19294467Guglielmi A, Ruzzenente A, Campagnaro T, Pachera S, Valdegamberi A, Nicoli P, Cappellani A, Malfermoni G, Iacono C. Intrahepatic cholangiocarcinoma: prognostic factors after surgical resection. World J Surg. 2009 Jun;33(6):1247-54. doi: 10.1007/s00268-009-9970-0.
- Background: PubMed 28077782Berretta M, Cavaliere C, Alessandrini L, Stanzione B, Facchini G, Balestreri L, Perin T, Canzonieri V. Serum and tissue markers in hepatocellular carcinoma and cholangiocarcinoma: clinical and prognostic implications. Oncotarget. 2017 Feb 21;8(8):14192-14220. doi: 10.18632/oncotarget.13929.
- Background: PubMed 30505597Altman AM, Kizy S, Marmor S, Huang JL, Denbo JW, Jensen EH. Current survival and treatment trends for surgically resected intrahepatic cholangiocarcinoma in the United States. J Gastrointest Oncol. 2018 Oct;9(5):942-952. doi: 10.21037/jgo.2017.11.06.
- Background: PubMed 32295646Bartsch F, Hahn F, Muller L, Baumgart J, Hoppe-Lotichius M, Kloeckner R, Lang H. Relevance of suspicious lymph nodes in preoperative imaging for resectability, recurrence and survival of intrahepatic cholangiocarcinoma. BMC Surg. 2020 Apr 15;20(1):75. doi: 10.1186/s12893-020-00730-x.
- Background: PubMed 23890842Dodson RM, Weiss MJ, Cosgrove D, Herman JM, Kamel I, Anders R, Geschwind JF, Pawlik TM. Intrahepatic cholangiocarcinoma: management options and emerging therapies. J Am Coll Surg. 2013 Oct;217(4):736-750.e4. doi: 10.1016/j.jamcollsurg.2013.05.021. Epub 2013 Jul 24. No abstract available.
- Background: PubMed 21730269de Jong MC, Nathan H, Sotiropoulos GC, Paul A, Alexandrescu S, Marques H, Pulitano C, Barroso E, Clary BM, Aldrighetti L, Ferrone CR, Zhu AX, Bauer TW, Walters DM, Gamblin TC, Nguyen KT, Turley R, Popescu I, Hubert C, Meyer S, Schulick RD, Choti MA, Gigot JF, Mentha G, Pawlik TM. Intrahepatic cholangiocarcinoma: an international multi-institutional analysis of prognostic factors and lymph node assessment. J Clin Oncol. 2011 Aug 10;29(23):3140-5. doi: 10.1200/JCO.2011.35.6519. Epub 2011 Jul 5.
- Background: PubMed 32097164Cambridge WA, Fairfield C, Powell JJ, Harrison EM, Soreide K, Wigmore SJ, Guest RV. Meta-analysis and Meta-regression of Survival After Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma. Ann Surg. 2021 Feb 1;273(2):240-250. doi: 10.1097/SLA.0000000000003801.
- Background: PubMed 34504109Brindley PJ, Bachini M, Ilyas SI, Khan SA, Loukas A, Sirica AE, Teh BT, Wongkham S, Gores GJ. Cholangiocarcinoma. Nat Rev Dis Primers. 2021 Sep 9;7(1):65. doi: 10.1038/s41572-021-00300-2.
- Individual participant dataSharing planned: Undecided. Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Goel, PhD principal investigator
City of Hope Medical Center
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma and Cholangiocarcinoma, Intrahepatic, run by City of Hope Medical Center at 4 sites in 2 countries.
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 3 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: finished, as of the sponsor's last update on 13 Mar 2026. 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 Japan, United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: Through study completion, an average of 1 year). 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 NCT06381648, which also lists 22 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 13 Mar 2026.