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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06658587

Enrollment

Registered

2024-10-26

Start date

2024-11-01

Completion date

2027-10-30

Last updated

2024-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTNo interventions

No interventions

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactHonghua Zhang, PhD

zhanghh68@mail.sysu.edu.cn020-34078840

Backup ContactChao Liu, PhD

liuchao3@mail.sysu.edu.cn+86 18922182850

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026