Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma (LyMIC)

Cholangiocarcinoma Clinical Trial

— LyMIC  

Official title:

An Exosome-based Liquid Biopsy Signature for Pre-operative Identification of Lymph Node Metastasis in Patients With Intrahepatic Cholangiocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381648
• Other study ID #: 23228/LyMIC
• Status: Recruiting
• Start date: April 15, 2023
• Est. completion date: June 18, 2026

Study information

• Verified date: May 2024
• Source: City of Hope Medical Center
• Contact: Ajay Goel, PhD
• Phone: 6262183452
• Email: AJGOEL[@]COH.ORG
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 18, 2026
• Est. primary completion date: June 18, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Lack of or inability to provide informed consent
• Synchronous Intrahepatic cholangiocarcinoma and non- Intrahepatic cholangiocarcinoma diagnosed at or before surgery
• Secondary liver cancer

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Cholangiocarcinoma Resectable
• Cholangiocarcinoma, Intrahepatic
• Lymphatic Metastasis
• Neoplasm Metastasis

Intervention

Diagnostic Test:
• 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)

Locations

Country	Name	City	State
Japan	Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University	Fukuoka
Japan	Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University	Hokkaido	Sapporo
Japan	Department of Surgery, Tokushima University	Tokushima
United States	City of Hope Medical Center	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
City of Hope Medical Center

Countries where clinical trial is conducted

United States,  Japan, 

References & Publications (22)

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Morine Y, Shimada M. The value of systematic lymph node dissection for intrahepatic cholangiocarcinoma from the viewpoint of liver lymphatics. J Gastroenterol. 2015 Sep;50(9):913-27. doi: 10.1007/s00535-015-1071-2. Epub 2015 Apr 2. — View Citation

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Sposito 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. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	True Positive Rate: the probability of a positive test result, conditioned on the individual truly being positive	Through study completion, an average of 1 year
Secondary	Specificity	True Negative Rate: the probability of a negative test result, conditioned on the individual truly being negative	Through study completion, an average of 1 year
Secondary	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	Through study completion, an average of 1 year