Observational Study on Patients With Hepatobiliary Tumors

• Conditions: Cholangiocarcinoma; Gallbladder Cancer; Biliary Tract Cancer; Hepatocellular Carcinoma; Gastric Cancer; Colorectal Cancer

• Registration Number: NCT04637048
• Lead Sponsor: Gang Chen, MD

Brief Summary

Hepatobiliary tumors have a poor prognosis and high individual heterogeneity, the patient with hepatobiliary tumors even accepted radical surgery, the postoperative recurrence rate is still high. Therefore, it is of great significance to find important prognostic markers to improve patient prognosis and formulate new treatment plans. In recent years, targeted therapy and immunotherapy make cancer treatment enter a new field, However, tumor heterogeneity is the greatest challenge in cancer therapeutics and biomarkers discovery. In this study, we collected a wide rang of patients' information, including photos of patients' face, physical strength and nutrition indicators, blood ,stool and pathological tissue specimens from tumor patients, then Multi-omics testing were applied to Looking for novel therapeutic targets and prognostic markers to predict patient response to treatment. Clinicians choose the best treatment plan for the patient based on the test results to improve the patient's survival time and quality of life.

Detailed Description

This is an ongoing, longitudinal, observational clinical cohort study of patients with tumors of the alimentary tract, mainly hepatobiliary tumors. All the patients are diagnosed, treated and followed up. In the future, some other patient information will be gradually updated to this database

Study Timeline

• Study Start: 2017-02-16
• Study First Submitted: 2020-11-14
• Study First Submitted QC: 2020-11-14
• Study First Posted: 2020-11-19
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-14
• Last Update Posted: 2022-06-16
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Be older than 18 years old;
2. Clinical or pathological diagnosis of malignant hepatobiliary tumors;
3. Patients have received or are about to receive surgery, chemotherapy radiotherapy, targeted therapy, local therapy, immunotherapy, etc;
4. Patients understand and are willing to sign written informed consent.

Exclusion Criteria

1. Patients considered by the doctor to be unsuitable for entry into this study (mental disorder or poor compliance, etc.);
2. The patient or guardian is unwilling to participate in this study;
3. Pregnant women;
4. Combined with other serious systemic diseases (heart failure, renal failure,hematopoietic system disease or Uncontrollable acute infection);
5. Estimated survival time is less than 1 month.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the overall survival rate of all patients with hepatobiliary tumor	5 years	In order to identify the potential influence factors of hepatobiliary tumor patients survival

Secondary Outcome Measures

Name	Time	Method
Evaluate the recurrence free survival rate of patients with hepatobiliary tumor	5 years	In order to identify the potential influence factors of tumor recurrencesamples from patients with hepatobiliary cancers
Evaluate the Progression Free Survival rate of patients with hepatobiliary tumor	5 years	In order to identify the potential influence factors of tumor progression from patients with hepatobiliary cancers
Evaluate the cancer-specific survival rate of patients with hepatobiliary tumor	5 years	In order to identify the potential influence factors of tumor-induced death in patients with hepatobiliary tumors

Trial Locations

Locations (1)

Gang Chen; 🇨🇳 Wenzhou, Zhejiang, China