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

NCT05721963 | Unknown DMC

• 1 other identifier: SYSKY-2023-087-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholangiocarcinoma

Keywords

Cholangiocarcinoma; Lymph Node Metastasis; Proteomics

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Interventions

No interventions. DIAGNOSTIC_TEST

No interventions.

Sun Yat-Sen Memorial Hospital of Sun Yat-sen University

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Histologically confirmed cholangiocarcinoma patients who underwent radical resection and lymphadenectomy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510220, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Resected lymph node samples will be profiled by proteomic approaches for lymph node metastasis status evaluation. And the residual samples will be kept in liquid nitrogen for a specific time.

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

• Chao Liu, PhD

  Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Honghua Zhang, Dr

CONTACT

020-34078840; zhanghh68@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 10, 2023
• Study Start: February 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)