Clinical trial NCT04637048: Observational Study on Patients With Hepatobiliary Tumors
Official title: Observational Study on Patients With Hepatobiliary Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Cholangiocarcinoma
Gallbladder Cancer
Biliary Tract Cancer
Gastric Cancer
Colorectal Cancer
Keywords: Hepatocellular Carcinoma
Cholangiocarcinoma
Gallbladder Cancer
Biliary Tract Cancer
blood sample
tissue sample
stool sample
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed and treated as hepatobiliary tumors and other alimentary tract tumors

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

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the overall survival rate of all patients with hepatobiliary tumor
timeFrame: 5 years
Secondary outcomes:
measure: Evaluate the recurrence free survival rate of patients with hepatobiliary tumor
timeFrame: 5 years
measure: Evaluate the cancer-specific survival rate of patients with hepatobiliary tumor
timeFrame: 5 years
measure: Evaluate the Progression Free Survival rate of patients with hepatobiliary tumor
timeFrame: 5 years
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Gang Chen
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Wenzhou Medical University
name: Gang Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: