Clinical trial · Observational
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
NCT05721963CI-TRIAL-00063845unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No interventions. | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Sun Yat-Sen Memorial Hospital of Sun Yat-sen University
- description
- The cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is the exploration cohort.
- interventionNames
- Diagnostic Test: No interventions.
Primary outcomes (2)
- measure
- Lymph node metastasis status of each examined lymph nodes by pathological tests
- timeFrame
- 1 month
- description
- The pathological examination results of each resected lymph nodes will be recorded
- measure
- Lymph node metastasis status of each lymph nodes evaluated by proteomic approaches
- timeFrame
- 2 month
- description
- Machine-learning clustering will be applied to classify the lymph node metastasis status of each lymph nodes based on proteomic profiles
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.