Observational Study on Patients With Hepatobiliary Tumors

Colorectal Cancer Clinical Trial

Official title:

Observational Study on Patients With Hepatobiliary Tumors

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04637048
• Other study ID #: Obs-Hepatobiliary CA
• Status: Enrolling by invitation
• Start date: February 16, 2017
• Est. completion date: December 1, 2023

Study information

• Verified date: June 2022
• Source: First Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Colorectal Cancer
• Gallbladder Cancer
• Gallbladder Neoplasms
• Gastric Cancer
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
China	Gang Chen	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Gang Chen, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the overall survival rate of all patients with hepatobiliary tumor	In order to identify the potential influence factors of hepatobiliary tumor patients survival	5 years
Secondary	Evaluate the recurrence free survival rate of patients with hepatobiliary tumor	In order to identify the potential influence factors of tumor recurrencesamples from patients with hepatobiliary cancers	5 years
Secondary	Evaluate the cancer-specific survival rate of patients with hepatobiliary tumor	In order to identify the potential influence factors of tumor-induced death in patients with hepatobiliary tumors	5 years
Secondary	Evaluate the Progression Free Survival rate of patients with hepatobiliary tumor	In order to identify the potential influence factors of tumor progression from patients with hepatobiliary cancers	5 years