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

NCT06658587 | Not Yet Recruiting DMC

• 1 other identifier: SYSKY-2024-352-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma

Keywords

Hilar Cholangiocarcinoma; Intrahepatic Cholangiocarcinoma; Extrahepatic Cholangiocarcinoma; Early Diagnosis; Non-invasive Diagnosis; Serological; Prognosis; Chemotherapeutic Benefits

Outcome Measures

Primary Outcomes (2)

• Malignant/Benign status of enrolled suspected cholangiocarcinoma patients by pathological examination

  The pathological examination results of each enrolled patient will be recorded

  4 weeks

• Malignant/Benign status of enrolled suspected cholangiocarcinoma patients evaluated by the novel serological risk model

  The novel serological risk model will be constructed for differential malignant/benign diagnosis

  2 weeks

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: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had suspected cholangiocarcinoma and completed the blood collection before surgery

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;
• \. Cholangiocarcinoma with resectable tumor lesions;
• \. Complete the blood collection before treatment;

You may not qualify if:

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

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

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collected blood samples will be tested for the concentration of novel serological markers to construct the serological risk model for differential diagnosis. And the residual samples will be kept in liquid nitrogen for a specific time.

MeSH Terms

Conditions

Cholangiocarcinoma; Klatskin Tumor; Disease

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; 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, PhD

CONTACT

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

Chao Liu, PhD

CONTACT

+86 18922182850; liuchao3@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: September 11, 2024
• First Posted: October 26, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2027
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)