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

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.

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.

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.