Liver CirrhosisNCT02335073
Effect of 4 Liver Fibrosis Tests (PIIINP, CIV, LN, and HA) on the Prognosis of Liver Cirrhosis
An observational study of Liver Cirrhosis, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
Liver biopsy is the reference method for the measurement of liver fibrosis. But it has many limitations, such as sampling error and individual variation in interpreting the results. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Venous blood
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Jun 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population should be patients with a diagnosis of liver cirrhosis who were admitted to the Department of Gastroenterology of the General Hospital of Shenyang Military Area.
Who may be able to join
- Patients were admitted to our department.
- Patients were diagnosed with liver cirrhosis.
- Patients signed the informed consent and agreed to test serum liver fibrosis markers (PIIINP, CIV, LN, and HA).
Who cannot join
- Non-cirrhotic patients.
- Malignancy.
- Severe cardiopulmonary diseases.
- Severe infectious diseases.
- Other diseases with a shortened lifespan.
- Pregnant and breastfeeding.
- Poor adherence.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, General Hospital of Shenyang Military Area
Shenyang, Liaoning, 110840
About this study
Official title: Effect of 4 Liver Fibrosis Tests (PIIINP, CIV, LN, and HA) on the Prognosis of Liver Cirrhosis: A Single-center, Prospective, Observational Study
Liver biopsy is the reference method for the measurement of liver fibrosis. But it has many limitations, such as sampling error and individual variation in interpreting the results. Currently, serum liver fibrosis markers have been employed as non-invasive diagnosis of liver fibrosis and evaluation of the severity of liver fibrosis. They include laminin (LN), hyaluronic acid (HA), collagen type IV (CIV), and N-terminal propeptide of collagen III (PIIINP). However, few study was conducted to explore the role of these liver fibrosis markers in evaluating the prognosis of liver cirrhosis. Our hypothesis is that LN, HA, CIV, and PIIINP in combination or alone can predict the prognosis of liver cirrhosis.
- Conditions
- Liver Cirrhosis
- Being tested
- Venous blood
- Keywords
- Prognosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous bloodOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: 6-12 months
Secondary outcomes (1)
Hepatic decompensation events
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingshun Qi, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335073
- Sponsor's protocol ID
- LFT4-LC
- Status last verified
- Feb 2024
- First submitted
- 7 Jan 2015
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 4 Liver Fibrosis Tests (PIIINP, CIV, LN, and HA) on the Prognosis of Liver Cirrhosis: A Single-center, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT02335073
- Acronym / sponsor ID
- LFT4-LC
- Conditions
- Liver Cirrhosis
- Keywords
- Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Jan 2015 (estimated)
- 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.
Liver biopsy is the reference method for the measurement of liver fibrosis. But it has many limitations, such as sampling error and individual variation in interpreting the results. Currently, serum liver fibrosis markers have been employed as non-invasive diagnosis of liver fibrosis and evaluation of the severity of liver fibrosis. They include laminin (LN), hyaluronic acid (HA), collagen type IV (CIV), and N-terminal propeptide of collagen III (PIIINP). However, few study was conducted to explore the role of these liver fibrosis markers in evaluating the prognosis of liver cirrhosis. Our hypothesis is that LN, HA, CIV, and PIIINP in combination or alone can predict the prognosis of liver cirrhosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population should be patients with a diagnosis of liver cirrhosis who were admitted to the Department of Gastroenterology of the General Hospital of Shenyang Military Area.
Key inclusion criteria (3 listed)
- Patients were admitted to our department.
- Patients were diagnosed with liver cirrhosis.
- Patients signed the informed consent and agreed to test serum liver fibrosis markers (PIIINP, CIV, LN, and HA).
Key exclusion criteria (7 listed)
- Non-cirrhotic patients.
- Malignancy.
- Severe cardiopulmonary diseases.
- Severe infectious diseases.
- Other diseases with a shortened lifespan.
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 |
|---|---|---|
| Venous blood | Other | – |
Primary outcome
Death
Time frame: 6-12 months
1 secondary outcome
Hepatic decompensation events
Time frame: 6-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Liver Cirrhosis, run by General Hospital of Shenyang Military Region 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 23 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Death (time frame: 6-12 months). 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 23 Feb 2024.