Hepatocellular CarcinomaNCT05286099
The Surveillance of Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Chinese PLA General Hospital at 2 sites in China.
Trial summary
Early detection of hepatocellular carcinoma is vita to the prognosis of patient. In this study, the occurrence and development of liver cancer were supervised by imaging examination, and the dysplastic nodules will be distinguished from early hepatocellular carcinoma through macro-imaging and micro-pathological… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Imaging examination and/or blood test
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 15 Jan 2022to 31 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hepatitis B, liver cirrhosis, or atypical hyperplasia nodules confirmed or suspected by enhanced imaging examination will be enrolled, the contrast-enhanced ultrasound and/or enhanced magnetic resonance imaging will be performed every three months or half a year to observe the size and contrast-enhanced features of the nodules. If the size or enhancement features change, there will a puncture biopsy under the guidance of ultrasound, and if malignant tumor cells are found, the follow-up will be terminated.
Who may be able to join
- Patients with Hepatitis B and cirrhosis Accept regular imaging examination. Pathological diagnosis of liver cancer.
Who cannot join
- Can't tolerate the enhanced imaging examination Poor medical compliance
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jie Yu, Doctor, 8601066939530, jiemi301@163.com
- Recruiting
Chinese PLA general hospital
Beijing
Jie Yu, 8601066939530, jiemi301@163.com
About this study
Official title: The Surveillance of Development and Progression of Hepatocellular Carcinoma
Early detection of hepatocellular carcinoma is vita to the prognosis of patient. In this study, the occurrence and development of liver cancer were supervised by imaging examination, and the dysplastic nodules will be distinguished from early hepatocellular carcinoma through macro-imaging and micro-pathological features.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Imaging examination and/or blood test
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging examination and/or blood testOther
Imaging examination and/or blood test will be performed at a certain time
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective detection of early hepatocellular carcinoma
The occurrence of early hepatocellular carcinoma
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start15 Jan 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion31 Dec 2023 (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 Chinese PLA General HospitalThe 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286099
- Sponsor's protocol ID
- S2022-001
- Status last verified
- Mar 2022
- First submitted
- 22 Feb 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Surveillance of Development and Progression of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05286099
- Acronym / sponsor ID
- S2022-001
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Mar 2022 (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.
Early detection of hepatocellular carcinoma is vita to the prognosis of patient. In this study, the occurrence and development of liver cancer were supervised by imaging examination, and the dysplastic nodules will be distinguished from early hepatocellular carcinoma through macro-imaging and micro-pathological features.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatitis B, liver cirrhosis, or atypical hyperplasia nodules confirmed or suspected by enhanced imaging examination will be enrolled, the contrast-enhanced ultrasound and/or enhanced magnetic resonance imaging will be performed every three months or half a year to observe the size and contrast-enhanced features of the nodules. If the size or enhancement features change, there will a puncture biopsy under the guidance of ultrasound, and if malignant tumor cells are found, the follow-up will be terminated.
Key inclusion criteria (1 listed)
- Patients with Hepatitis B and cirrhosis Accept regular imaging examination. Pathological diagnosis of liver cancer.
Key exclusion criteria (1 listed)
- Can't tolerate the enhanced imaging examination Poor medical compliance
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 |
|---|---|---|
| Imaging examination and/or blood testImaging examination and/or blood test will be performed at a certain time | Other | – |
Primary outcome
Effective detection of early hepatocellular carcinoma
Time frame: 2 years
The occurrence of early hepatocellular carcinoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
2 sites 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 Chinese PLA General Hospital at 2 sites 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 1 inclusion and 1 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 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective detection of early hepatocellular carcinoma (time frame: 2 years). 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 18 Mar 2022.