Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma (LyMIC)

NCT06381648 | Completed

• 1 other identifier: 23228/LyMIC
• Study Type: observational
• Target: 230
• Locations: 2 countries
• Sites: 4

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Specificity

  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)

  Through study completion, an average of 1 year

Study Arms (4)

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.

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.

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.

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.

Diagnostic Test: LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma)

Interventions

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)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who were diagnosed with Intrahepatic cholangiocarcinoma

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (4)

City of Hope Medical Center

Duarte, California, 91016, United States

Location

Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University

Hokkaido, Sapporo, 060-8648, Japan

Location

Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University

Fukuoka, 812-8582, Japan

Location

Department of Surgery, Tokushima University

Tokushima, 770-8503, Japan

Location

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MeSH Terms

Conditions

Cholangiocarcinoma; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ajay Goel, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: April 15, 2023
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1); JP (3)