Hepatocellular CarcinomaNCT04021056
Observational Study on Patients With Hepatocellular Carcinoma (HCC)
An observational study of Hepatocellular Carcinoma, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This is an ongoing, longitudinal, single centre, observational, retro-prospective clinical cohort study of patients with HCC in usual clinical practice. All the HCC patients diagnosed and treated in Liver Cancer Center, Nanfang Hospital are consecutively collected and followed up. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2011to 31 Dec 2022
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed and treated as HCC in Liver Cancer Center, Nanfang Hospital
Who may be able to join
- Clinical diagnosis of HCC;
- Age ≥ 16 years;
- Received treatment targeting for HCC at least once, including operation, ablation, TACE, sorafenib, radiotherapy, chemotherapy, etc;
- Good compliance with clinical treatment.
Who cannot join
- Diagnosed as other pathological types such as cholangiocarcinoma, or mixed liver cancer;
- Received only traditional Chinese medicine or symptomatic supportive treatment; (3) survival time ≤ 7 days;
- HCC diagnosed after liver transplantation;
- Poor compliance or important data deficient.
Trial locations and contacts
1 site in 1 country.
Jinlin Hou contact
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong
Jinlin Hou, jlhousmu@163.com
About this study
This is an ongoing, longitudinal, single centre, observational, retro-prospective clinical cohort study of patients with HCC in usual clinical practice. All the HCC patients diagnosed and treated in Liver Cancer Center, Nanfang Hospital are consecutively collected and followed up.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- No intervention
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the overall survival rate of all HCC patients
In order to identify the potential influence factors of HCC patients survival
Measured: 10 years
Evaluate the recurrence free survival rate of HCC patients after curative treatments
In order to identify the potential influence factors of tumor recurrence
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Jan 2011
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinlin Hou, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021056
- Sponsor's protocol ID
- NFHCC-01
- Status last verified
- Jul 2019
- First submitted
- 23 Apr 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Patients With Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT04021056
- Acronym / sponsor ID
- NFHCC-01
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 16 Jul 2019 (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.
This is an ongoing, longitudinal, single centre, observational, retro-prospective clinical cohort study of patients with HCC in usual clinical practice. All the HCC patients diagnosed and treated in Liver Cancer Center, Nanfang Hospital are consecutively collected and followed up.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed and treated as HCC in Liver Cancer Center, Nanfang Hospital
Key inclusion criteria (4 listed)
- Clinical diagnosis of HCC;
- Age ≥ 16 years;
- Received treatment targeting for HCC at least once, including operation, ablation, TACE, sorafenib, radiotherapy, chemotherapy, etc;
- Good compliance with clinical treatment.
Key exclusion criteria (4 listed)
- Diagnosed as other pathological types such as cholangiocarcinoma, or mixed liver cancer;
- Received only traditional Chinese medicine or symptomatic supportive treatment; (3) survival time ≤ 7 days;
- HCC diagnosed after liver transplantation;
- Poor compliance or important data deficient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | – |
Primary outcome
Evaluate the overall survival rate of all HCC patients
Time frame: 10 years
In order to identify the potential influence factors of HCC patients survival
Evaluate the recurrence free survival rate of HCC patients after curative treatments
Time frame: 10 years
In order to identify the potential influence factors of tumor recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
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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.
Jinlin Hou contact
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, run by Nanfang Hospital, Southern Medical University 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 4 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 Jul 2019. 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?
Contact Jinlin Hou (jlhousmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the overall survival rate of all HCC patients (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2019.