Observational Study on Patients With Hepatobiliary Tumors

June 14, 2022 updated by: Gang Chen, MD
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.

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Gang Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed and treated as hepatobiliary tumors and other alimentary tract tumors

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the overall survival rate of all patients with hepatobiliary tumor
Time Frame: 5 years
In order to identify the potential influence factors of hepatobiliary tumor patients survival
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gang Chen, MD

Investigators

  • Principal Investigator: Gang Chen, M.D., First Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2017

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

November 14, 2020

First Submitted That Met QC Criteria

November 14, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2022

Last Update Submitted That Met QC Criteria

June 14, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Obs-Hepatobiliary CA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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