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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2027-10-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cholangiocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions

Intervention Type DIAGNOSTIC_TEST

No interventions

Interventions

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No interventions

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes