Study on the Accuracy of Proteomics in Evaluating Lymph Node Metastasis Status in Cholangiocarcinoma Patients

Clinical Study on the Accuracy of Proteomics in Evaluating Lymph Node Metastasis Status and Comparation With Pathological Examination in Cholangiocarcinoma Patients

This is a single-center, prospective, observational and exploratory clinical study. The object of this study is to evaluate the accuracy of proteomics approaches on resected lymph node samples in evaluating lymph node metastasis status in cholangiocarcinoma patients.

Study Overview

• Status: Recruiting
• Conditions: Cholangiocarcinoma
• Intervention / Treatment: Diagnostic test: No interventions.

Detailed Description

The current gold standard for the diagnosis of lymph node metastasis is pathological examination of surgically resected lymph node specimens. However, lymph node metastases are different from the primary lesions, and the distribution of tumor cells is heterogeneous and more dispersed. Therefore, a single thin pathological section is difficult to obtain complete information, which may be misdiagnosed due to the failure to examine on the section containing tumor cells or the presence of micro-metastases.

The application of proteomics can obtain the overall information of the samples, including the remodeling of the microenvironment by the tumor metastases and the acclimation even before the metastasis, resulting in significant changes in the protein expression profiles of the lymph nodes, which are difficult to be completely presented in conventional pathological sections. This study aims to evaluate the accuracy of proteomics approaches on resected lymph node samples in evaluating lymph node metastasis status in cholangiocarcinoma patients, assisting in guiding precision medicine and making therapeutic decisions.

Positive controls of lymph node metastases and negative controls of normal lymph nodes were previously profiled using proteomic approaches. Machine-learning clustering method will be used to classify the newly examined lymph nodes.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Honghua Zhang, Dr; Phone Number: 020-34078840; Email: zhanghh68@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510220
      • Recruiting
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Histologically confirmed cholangiocarcinoma patients who underwent radical resection and lymphadenectomy

Description

Inclusion Criteria:

• The patient must sign an informed consent form;
• Age 18-75 years old, both male and female;
• ECOG performance status score (PS score) 0-2;
• Child-Pugh score A period;
• Have not received any systemic treatment within 6 months;
• The functional indicators of important organs meet the following requirements (1)Neutrophils≥1.5*109/L; platelets≥100*109/L; hemoglobin≥9g/dl; serum albumin≥3g/dl; (2)Thyroid-stimulating hormone (TSH) ≤ 2 times the upper limit of normal, and T3 and T4 are in the normal range; (3)Bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 3 times the upper limit of normal; (4)Serum creatinine ≤ 1.5 times the upper limit of normal, and creatinine clearance ≥ 60ml/min (calculated by Cockcroft-Gault formula);
• For women who are not breastfeeding or pregnant, use contraception during treatment or 12 months after the end of treatment.

Exclusion Criteria:

• Unresectable cholangiocarcinoma patients or postoperative diagnosis of cholangiocarcinoma recurrence and metastasis;
• Past or simultaneous suffering from other malignant tumors;
• Have used gemcitabine-based chemotherapy or radiotherapy within 6 months;
• Severe cardiopulmonary and renal dysfunction;
• Hypertension that is difficult to control with drugs (systolic blood pressure (BP) ≥140 mmHg and/or diastolic blood pressure ≥90mmHg) (based on the average of ≥3 BP readings obtained by ≥2 measurements);
• Abnormal coagulation function (PT>14s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy;
• After antiviral treatment, HBV DNA>2000 copies/ml, HCV RNA>1000;
• A history of esophageal and gastric varices, significant clinically significant bleeding symptoms or a clear tendency to appear within 3 months before enrollment;
• Active infections requiring systemic treatment; patients with active tuberculosis infection within 1 year before enrollment; a history of active tuberculosis infection more than 1 year before enrollment, and no formal anti-tuberculosis treatment or tuberculosis Still in the active period;
• Human immunodeficiency virus (HIV, HIV1/2 antibody) positive;
• A history of psychotropic drug abuse, alcohol or drug abuse;
• Other factors judged by the investigator may affect the safety of the subjects or the compliance of the trial. Such as serious diseases (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sun Yat-Sen Memorial Hospital of Sun Yat-sen University; The cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is the exploration cohort.	Diagnostic test: No interventions.; No interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymph node metastasis status of each examined lymph nodes by pathological tests	The pathological examination results of each resected lymph nodes will be recorded	1 month
Lymph node metastasis status of each lymph nodes evaluated by proteomic approaches	Machine-learning clustering will be applied to classify the lymph node metastasis status of each lymph nodes based on proteomic profiles	2 month

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2023
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (ACTUAL): February 10, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Proteomics; Cholangiocarcinoma; Lymph Node Metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplastic Processes; Neoplasm Metastasis; Lymphatic Metastasis; Cholangiocarcinoma
• Other Study ID Numbers: SYSKY-2023-087-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No