Chronic Liver DiseasePVNIMNCT02060565
Prognosis Value of Non-invasive Methods for the Diagnosis of Chronic Liver Disease
An observational study of Chronic Liver Disease, run by Association HGE CHU Bordeaux Sud at 1 site in France.
Trial summary
The aim of this retrospective and prospective study is to evaluate the 20-year prognosis value of non-invasive methods for the diagnosis of chronic liver disease for predicting survival and complications of cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease
- How many people
- 10,000 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Feb 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: all consecutive patients with an age over eighteen and chronic liver disease
Who may be able to join
- chronic hepatitis C
- chronic hepatitis B
- alcohol liver disease
- non alcoholic liver disease
Who cannot join
- ascitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre d'Investigation de la Fibrose hépatique Service Hépato-Gastroentérologie Hopital Haut-Lévèque
Pessac, 33200
Victor de Lédinghen, MD, PhD, 0033557656439, victor.deledinghen@chu-bordeaux.fr
Juliette Foucher, MD, 0033557656439, juliette.foucher@chu-bordeaux.fr
About this study
Official title: Prognosis Value of Non-invasive Methods for the Diagnosis of Chronic Liver Disease. a Retrospective and Prospective 20-year Follow-up.
The aim of this retrospective and prospective study is to evaluate the 20-year prognosis value of non-invasive methods for the diagnosis of chronic liver disease for predicting survival and complications of cirrhosis.
Read the detailed description
All consecutive patients with chronic liver disease will be followed during 20 years.
- Conditions
- Chronic Liver Disease
- Keywords
- diagnosis, survival, non-invasive method, cirrhosis, FibroScan
- Medical subject headings
- Disease, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic liver disease | all patients with chronic liver disease followed using non-invasive methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 20 years
Secondary outcomes (1)
Survival without liver complications
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2030 (estimated)
- Study completionFeb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association HGE CHU Bordeaux Sud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliette Foucher, MD, Study chair, Association HGE CHU Bordeaux SudFaiza Chermak, MD, Study chair, Association HGE CHU Bordeaux SudVictor de Lédinghen, MD, PhD, Study director, Association HGE CHU Bordeaux SudJean-Baptiste Hiriart, MD, Study chair, Association HGE CHU Bordeaux Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060565
- Sponsor's protocol ID
- HL V-0214
- Acronym
- PVNIM
- Status last verified
- Jul 2023
- First submitted
- 11 Feb 2014
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Value of Non-invasive Methods for the Diagnosis of Chronic Liver Disease. a Retrospective and Prospective 20-year Follow-up.
- ClinicalTrials.gov ID
- NCT02060565
- Acronym / sponsor ID
- PVNIM / HL V-0214
- Conditions
- Chronic Liver Disease
- Keywords
- diagnosis, survival, non-invasive method, cirrhosis, FibroScan
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Association HGE CHU Bordeaux SudUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Feb 2034 (estimated)
- First posted
- 12 Feb 2014 (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.
The aim of this retrospective and prospective study is to evaluate the 20-year prognosis value of non-invasive methods for the diagnosis of chronic liver disease for predicting survival and complications of cirrhosis.
Detailed description
All consecutive patients with chronic liver disease will be followed during 20 years.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic liver disease | – | –all patients with chronic liver disease followed using non-invasive methods |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all consecutive patients with an age over eighteen and chronic liver disease
Key inclusion criteria (4 listed)
- chronic hepatitis C
- chronic hepatitis B
- alcohol liver disease
- non alcoholic liver disease
Key exclusion criteria (1 listed)
- ascitis
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
Overall survival
Time frame: 20 years
1 secondary outcome
Survival without liver complications
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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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.
Juliette Foucher, MD study chair
Association HGE CHU Bordeaux Sud
Faiza Chermak, MD study chair
Association HGE CHU Bordeaux Sud
Victor de Lédinghen, MD, PhD study director
Association HGE CHU Bordeaux Sud
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 Chronic Liver Disease, run by Association HGE CHU Bordeaux Sud at 1 site in France.
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 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: looking for participants now, as of the sponsor's last update on 20 Jul 2023. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor de Lédinghen, MD, PhD (0033557656439, victor.deledinghen@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 20 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 20 Jul 2023.