A Novel Serological Risk Model for Early Non-invasive Diagnosis of Cholangiocarcinoma

Not yet recruiting

• Conditions: Cholangiocarcinoma

• Registration Number: NCT06658587
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

This is a prospective, observational and exploratory clinical study. The object of this study is to evaluate the accuracy of a novel serological risk model on blood samples in early diagnosis of cholangiocarcinoma patients.

Detailed Description

A reliable and accurate preoperative tool capable of early diagnosing malignant cholangiocarcinoma is lacking and urgently needed for clinical practice. This study proposes to establish and evaluate a novel serological risk model on blood samples for non-invasively diagnosing cholangiocarcinoma. The study includes the construction of capable novel serological risk model and the validation of the diagnosis model.

Study Timeline

• Study First Submitted: 2024-09-11
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Study First Posted: 2024-10-26
• Last Update Posted: 2024-10-26
• Study Start: 2024-11-01
• Primary Completion: 2026-10-30
• Study Completion: 2027-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1. The patient must sign an informed consent form;
• 2. Age 18-75 years old, both male and female;
• 3. ECOG performance status score (PS score) 0-2;
• 4. Cholangiocarcinoma with resectable tumor lesions;
• 5. Complete the blood collection before treatment;

Exclusion Criteria

• 1. Accompanied with other primary malignant tumors;
• 2. Patients who have neoadjuvant chemotherapy or other tumor-targeted therapies;
• 3. Incomplete serological examinations or medical history data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Malignant/Benign status of enrolled suspected cholangiocarcinoma patients by pathological examination	4 weeks	The pathological examination results of each enrolled patient will be recorded
Malignant/Benign status of enrolled suspected cholangiocarcinoma patients evaluated by the novel serological risk model	2 weeks	The novel serological risk model will be constructed for differential malignant/benign diagnosis

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China