NCT04637048

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2017

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

6.8 years

First QC Date

November 14, 2020

Last Update Submit

June 14, 2022

Conditions

Hepatocellular CarcinomaCholangiocarcinomaGallbladder CancerBiliary Tract CancerGastric CancerColorectal Cancer

Keywords

Hepatocellular CarcinomaCholangiocarcinomaGallbladder CancerBiliary Tract Cancerblood sampletissue samplestool sample

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Evaluate the recurrence free survival rate of patients with hepatobiliary tumor

    5 years

  • Evaluate the cancer-specific survival rate of patients with hepatobiliary tumor

    5 years

  • Evaluate the Progression Free Survival rate of patients with hepatobiliary tumor

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gang Chen

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (1)

  • Yang J, Wang D, Ma L, An X, Hu Z, Zhu H, Zhang W, Chen K, Ma J, Yang Y, Wu L, Chen G, Wang Y. Sarcopenia negatively affects postoperative short-term outcomes of patients with non-cirrhosis liver cancer. BMC Cancer. 2023 Mar 6;23(1):212. doi: 10.1186/s12885-023-10643-6.

    PMID: 36879265DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

normal tissue, tumor samples, blood, urine, feces, ascites, bile samples

MeSH Terms

Conditions

Carcinoma, HepatocellularCholangiocarcinomaGallbladder NeoplasmsBiliary Tract NeoplasmsStomach NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesBiliary Tract DiseasesGallbladder DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesStomach DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Gang Chen, M.D.

    First Affiliated Hospital of Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Division Chief of Education; Deputy Director of Hepatobiliary Surgery

Study Record Dates

First Submitted

November 14, 2020

First Posted

November 19, 2020

Study Start

February 16, 2017

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

June 16, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)