NAFLDIMPROVENCT04146636
Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients (IMPROVE Study)
A study testing e-LIFT in people with NAFLD and Alcohol-Related Disorder, run by University Hospital, Angers at 1 site in France.
Trial summary
The main objective is to determine the performance of the simple eLIFT blood test for advanced liver fibrosis screening in NAFLD and/or alcoholic patients in primary care. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- NAFLD, Alcohol-Related Disorder, Liver Fibrosis
- What is being tested?
- e-LIFT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2019to 26 Nov 2020
- Phase
- Interventional
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NAFLD and/or alcoholic patient defined by ≥1 of the following criteria:
- Excessive alcohol consumption: >210 g/week (men), >140 g/week (women)
- Type 2 diabetes
- ≥2 metabolic factors among: 1/BMI ≥25kg/m2; 2/elevated blood pressure (antihypertensive drug, or systolic blood pressure ≥130mmHg, or diastolic blood pressure ≥85mmHg), 3/dyslipidemia (lipid-lowering drug, or HDL cholesterol <40mg/dl (men) / <50mg/dl (women), or triglycerides ≥150mg/dl); 4/hyperferritinemia (>300 ng/ml (men)/>200 ng/ml (women))
- Bright liver at ultrasonography without steatosis-inducing drug
- Obtaining the signature of the consent to participate in the study
Who cannot join
- Already ongoing specialized follow-up for a chronic liver disease
- Altered health status with poor short-term prognosis, not compatible with a screening procedure
- Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)
- Acute infection
- Inadequate understanding of the French language
- Pregnant, breastfeeding or parturient women
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- Persons deprived of their liberty by judicial or administrative decision
- Persons subject to legal protection measures
- Persons unable to consent
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
The main objective is to determine the performance of the simple eLIFT blood test for advanced liver fibrosis screening in NAFLD and/or alcoholic patients in primary care.
Read the detailed description
eLIFT, is a new blood fibrosis test specifically dedicated for general practitioners with simple parameters and easy "by head" calculation. Using the recommended cut-offs (eLIFT ≥8), eLIFT sensitivity was 86%. This result position eLIFT an as interesting tool for the screening of advanced liver fibrosis in large populations.
As our preliminary results come from very selected patients, i.e. patients from tertiary centres who underwent a liver biopsy, we now need to evaluate in the real condition of primary care setting whether the use of eLIFT will help general practitioners to screen advanced liver fibrosis in their asymptomatic NAFLD and alcoholic patients.
- Conditions
- NAFLD, Alcohol-Related Disorder, Liver Fibrosis
- Being tested
- e-LIFT
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Alcohol-Related Disorders, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-LIFTDiagnostic test
Diagnostic procedure: elastography devices, blood tests (e-LIFT), liver biopsy if necessary (elstometry ≥ 8 kPa and < 15 kPa)
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Test: e-LIFT | Other | only one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference Receives: Diagnostic Test: e-LIFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
e-LIFT negative predictive value for the diagnosis of advanced hepatic fibrosis
The primary outcome of the study is the negative predictive value for the diagnosis of advanced hepatic fibrosis (i.e., the rate of patients who do not actually have advanced hepatic fibrosis when the eLIFT test is <8)
Measured: 1 day
Secondary outcomes (4)
sensibility of the eLIFT test
Rate of patients with an eLIFT test ≥8 among patients with advanced hepatic fibrosis
Measured: 1 day
specificity and positive predictive value of the eLIFT test
Rate of patients with an eLIFT test ≥8 but without a final diagnosis of advanced hepatic fibrosis (false positives), specificity (i. e. the rate of patients with an eLIFT test < 8 among patients without advanced hepatic fibrosis) and positive predictive value of the eLIFT test (i. e. the rate of patients with effective advanced hepatic fibrosis when the eLIFT test is ≥ 8)
Measured: 1 day
rate of liver complications among patients with an eLIFT test ≥ 8
Rate of patients with hepatocellular carcinoma (diagnosed by recommended radiological criteria or liver biopsy); rate of patients with gastroesophageal varices at risk of bleeding diagnosed by gastrointestinal endoscopy (according to Baveno VI rules: medium to large or small varices with red signs) among patients with an eLIFT test is ≥ 8
Measured: 1 day
performance of e-LIFT test in subgroup analysis
Rates of patients with advanced hepatic fibrosis, hepatocellular carcinoma rate, gastroesophageal varicose vein rate at risk of bleeding, eLIFT test rate ≥8, sensitivity, specificity, negative predictive value, positive predictive value in each subgroup (NAFLD, alcohol and NAFLD + alcohol)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start9 Dec 2019
- Primary completion8 Sep 2020
- Study completion26 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective diagnostic study in primary care. Evaluation of a simple blood test (e-LIFT) for the diagnosis of advanced liver fibrosis. Reference for advanced liver diagnosis : composite criteria : * Elastometry between 8 kPa and 15 kPa and histologic evaluation of fibrosis ≥ F3 (NASH CRN ) OR * Elastometry ≥ 15 kPa
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146636
- Sponsor's protocol ID
- 2019-A01895-52
- Acronym
- IMPROVE
- Status last verified
- May 2022
- First submitted
- 29 Oct 2019
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients (IMPROVE Study)
- ClinicalTrials.gov ID
- NCT04146636
- Acronym / sponsor ID
- IMPROVE / 2019-A01895-52
- Conditions
- NAFLD, Alcohol-Related Disorder, Liver Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 8 Sep 2020 (actual)
- Study completion
- 26 Nov 2020 (actual)
- First posted
- 31 Oct 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.
The main objective is to determine the performance of the simple eLIFT blood test for advanced liver fibrosis screening in NAFLD and/or alcoholic patients in primary care.
Detailed description
eLIFT, is a new blood fibrosis test specifically dedicated for general practitioners with simple parameters and easy "by head" calculation. Using the recommended cut-offs (eLIFT ≥8), eLIFT sensitivity was 86%. This result position eLIFT an as interesting tool for the screening of advanced liver fibrosis in large populations.
As our preliminary results come from very selected patients, i.e. patients from tertiary centres who underwent a liver biopsy, we now need to evaluate in the real condition of primary care setting whether the use of eLIFT will help general practitioners to screen advanced liver fibrosis in their asymptomatic NAFLD and alcoholic patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective diagnostic study in primary care. Evaluation of a simple blood test (e-LIFT) for the diagnosis of advanced liver fibrosis. Reference for advanced liver diagnosis : composite criteria : * Elastometry between 8 kPa and 15 kPa and histologic evaluation of fibrosis ≥ F3 (NASH CRN ) OR * Elastometry ≥ 15 kPa
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Test: e-LIFT | Other | Diagnostic Test: e-LIFTonly one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- NAFLD and/or alcoholic patient defined by ≥1 of the following criteria:
- Obtaining the signature of the consent to participate in the study
Key exclusion criteria (10 listed)
- Already ongoing specialized follow-up for a chronic liver disease
- Altered health status with poor short-term prognosis, not compatible with a screening procedure
- Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)
- Acute infection
- Inadequate understanding of the French language
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 |
|---|---|---|
| e-LIFTDiagnostic procedure: elastography devices, blood tests (e-LIFT), liver biopsy if necessary (elstometry ≥ 8 kPa and < 15 kPa) | Diagnostic test | Diagnostic Test: e-LIFT |
Primary outcome
e-LIFT negative predictive value for the diagnosis of advanced hepatic fibrosis
Time frame: 1 day
The primary outcome of the study is the negative predictive value for the diagnosis of advanced hepatic fibrosis (i.e., the rate of patients who do not actually have advanced hepatic fibrosis when the eLIFT test is <8)
4 secondary outcomes
sensibility of the eLIFT test
Time frame: 1 day
specificity and positive predictive value of the eLIFT test
Time frame: 1 day
rate of liver complications among patients with an eLIFT test ≥ 8
Time frame: 1 day
performance of e-LIFT test in subgroup analysis
Time frame: 1 day
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 18 May 2022.
- 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?
A study testing e-LIFT in people with NAFLD and Alcohol-Related Disorder, run by University Hospital, Angers 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 6 inclusion and 10 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 18 May 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 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?
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?
e-LIFT negative predictive value for the diagnosis of advanced hepatic fibrosis (time frame: 1 day). 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 May 2022.