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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No interventions | Diagnostic Test | No interventions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Malignant/Benign status of enrolled suspected cholangiocarcinoma patients by pathological examination | 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 | The novel serological risk model will be constructed for differential malignant/benign diagnosis | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who had suspected cholangiocarcinoma and completed the blood collection before surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Honghua Zhang, PhD | Contact | 020-34078840 | zhanghh68@mail.sysu.edu.cn | |
| Chao Liu, PhD | Contact | +86 18922182850 | liuchao3@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chao Liu, PhD | Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510220 | China |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D018285 | Klatskin Tumor |
| D004194 | Disease |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Collected blood samples will be tested for the concentration of novel serological markers to construct the serological risk model for differential diagnosis. And the residual samples will be kept in liquid nitrogen for a specific time.
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |