Hepatocellular CarcinomaNCT04637048
Observational Study on Patients With Hepatobiliary Tumors
An observational study of Hepatocellular Carcinoma and Cholangiocarcinoma, run by Gang Chen, MD at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Cholangiocarcinoma, Gallbladder Cancer
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2017to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed and treated as hepatobiliary tumors and other alimentary tract tumors
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- 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
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma, Gallbladder Neoplasms, Biliary Tract Neoplasms, Stomach Neoplasms, Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the overall survival rate of all patients with hepatobiliary tumor
In order to identify the potential influence factors of hepatobiliary tumor patients survival
Measured: 5 years
Secondary outcomes (3)
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
Measured: 5 years
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
Measured: 5 years
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start16 Feb 2017
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gang Chen, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gang Chen, MD, First Affiliated Hospital of Wenzhou Medical University
- Investigators
- Gang Chen, M.D., Principal investigator, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637048
- Sponsor's protocol ID
- Obs-Hepatobiliary CA
- Status last verified
- Jun 2022
- First submitted
- 14 Nov 2020
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36879265
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Patients With Hepatobiliary Tumors
- ClinicalTrials.gov ID
- NCT04637048
- Acronym / sponsor ID
- Obs-Hepatobiliary CA
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Gang Chen, MDUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed and treated as hepatobiliary tumors and other alimentary tract tumors
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Evaluate the recurrence free survival rate of patients with hepatobiliary tumor
Time frame: 5 years
Evaluate the cancer-specific survival rate of patients with hepatobiliary tumor
Time frame: 5 years
Evaluate the Progression Free Survival rate of patients with hepatobiliary tumor
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Derived from this study: PubMed 36879265Yang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Chen, M.D. principal investigator
First Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Cholangiocarcinoma, run by Gang Chen, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the overall survival rate of all patients with hepatobiliary tumor (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04637048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.