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

October 24, 2024 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Clinical Study on the Accuracy of Novel Serological Risk Model in Early Diagnosis of Cholangiocarcinoma Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510220
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Malignant/Benign status of enrolled suspected cholangiocarcinoma patients by pathological examination
Time Frame: 4 weeks
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
Time Frame: 2 weeks
The novel serological risk model will be constructed for differential malignant/benign diagnosis
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Chao Liu, PhD, Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2027

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2024-352-01

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholangiocarcinoma

Clinical Trials on No interventions

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe