A Novel Serological Risk Model for Early Non-invasive Diagnosis of Cholangiocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No interventions.
- Who it may be relevant to
- Registry conditions: Cholangiocarcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Study on the Accuracy of Novel Serological Risk Model in Early Diagnosis of Cholangiocarcinoma Patients
Overview
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 test No interventions
No interventions
Primary outcome measures
- Malignant/Benign status of enrolled suspected cholangiocarcinoma patients by pathological examination [Time frame: 4 weeks]
- Malignant/Benign status of enrolled suspected cholangiocarcinoma patients evaluated by the novel serological risk model [Time frame: 2 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT06658587 · SYSKY-2024-352-01