Metabolic Dysfunction-Associated Steatotic Liver DiseaseLiverSeekNCT07658755

Automated Passive Case-Finding for Advanced Liver Fibrosis in MASLD: The LiverSeek Programme

An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease and Liver Fibrosis, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 50 to 75 years
Conditions the study is for: Metabolic Dysfunction-Associated Steatotic Liver Disease, Liver Fibrosis, Non-alcoholic Fatty Liver Disease NAFLD
How many people: 3,000 participants
Where: 1 siteSpain
Study dates: 1 Oct 2024to 1 Sep 2027
How long will I take part?: 24 Months
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 50 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients attending primary care in peri-urban Madrid (SERMAS network) with metabolic risk factors for liver fibrosis, identified passively through routine laboratory data

Who may be able to join

Age between 50 and 75 years (inclusive)
Routine blood test processed in the Clinical Biochemistry Laboratory of Hospital General Universitario Gregorio Marañón, ordered by a primary care physician in one of the 11 affiliated SERMAS primary care centres
Presence of at least one of the following metabolic risk factor combinations:
ALT above the upper limit of normal AND HbA1c ≥6.5%
ALT above the upper limit of normal AND BMI >30 kg/m²
BMI >30 kg/m² AND HbA1c ≥6.5%

Who cannot join

Age <50 years or >75 years
Known pre-existing liver disease (significant or advanced fibrosis, cirrhosis, hepatocellular carcinoma, prior liver transplantation)
Prior fibrosis assessment within the preceding 12 months.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Luis Ibáñez-Samaniego, MD, PhD contact

+34 91 586 8308

luis.ibanez@salud.madrid.org

Spain1 site, 1 recruiting

Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Luis Ibáñez-Samaniego, MD, PhD, +34 91 586 8308, luis.ibanez@salud.madrid.org
Susana Sanchez Berdial, Pharm, ssberdial@salud.madrid.org
Recruiting

Other trials in Spain

About this study

Official title: Towards Universal Screening for Metabolic Dysfunction-Associated Liver Fibrosis in Primary Care: Evaluation of a Single-Step, Laboratory Informatión System-Driven Automated Case-Finding Strategy (LiverSeek)

LiverSeek is a fully automated, passive case-finding programme for advanced liver fibrosis associated with metabolic dysfunction-associated steatotic liver disease (MASLD) in primary care. The programme operates through the Laboratory Information System (LIS; Modulab/Biwer Analytics) of the Clinical Biochemistry Laboratory at Hospital General Universitario Gregorio Marañón (HGUGM), covering approximately 350,000 inhabitants across 11 peri-urban primary care centres affiliated to SERMAS (Servicio Madrileño de Salud) in Madrid, Spain.

When a high-risk patient (age 50-75 years with ≥1 of: ALT above ULN + HbA1c ≥6.5%; ALT above ULN + BMI >30; BMI >30 + HbA1c ≥6.5%) undergoes a routine blood test in primary care, the LIS automatically calculates FIB-4. If FIB-4 >1.30, the system reflexively orders ELF and MASEF from the same serum sample, without any action required from the primary care clinician. Patients with a positive second-step NIT (ELF ≥9.8 or MASEF ≥0.33) receive an automatic alert directing them to the Hepatology Advanced Practice Nurse for VCTE (FibroScan) and clinical evaluation.

The primary objective is to evaluate the prevalence of hepatic fibrosis in the high-risk population using this single-step automated strategy. Secondary objectives include head-to-head diagnostic comparison of FIB-4+ELF vs FIB-4+MASEF vs FIB-4+FAST for histologically-confirmed endpoints (significant fibrosis ≥F2, advanced fibrosis ≥F3, at-risk MASH), evaluation of the Liver Risk Score, and a health-economic analysis. A sub-study evaluates a nurse-led structured lifestyle intervention in NIT-positive patients.

Read the detailed description

LiverSeek addresses a well-recognised implementation gap: despite guideline recommendations to screen for liver fibrosis in high-risk metabolic patients, fewer than one-third of eligible patients are assessed in clinical practice. Encounter-triggered programmes (e.g., SOLID, PRELUDE1) require primary care clinicians to initiate the assessment process, creating a dependency on clinician awareness and workload capacity that limits scalability.

LiverSeek adopts a fundamentally different model: the screening process is initiated passively by the LIS infrastructure, triggered by existing routine blood test data, with zero additional burden on the primary care clinician. This passive architecture is the programme's principal conceptual innovation.

NIT pathway and pre-specified thresholds:

Step 1 (LIS-triggered): FIB-4 calculated automatically. Threshold: >1.30 (EASL 2024) Step 2 (reflex, same serum sample): ELF (threshold ≥9.8) and MASEF (threshold ≥0.33, Youden J-point) Step 2 alternative (VCTE-based): VCTE ≥8.0 kPa; FAST score ≥0.50 (Youden J-point) NIT-positive patients → Hepatology APN visit (VCTE, anthropometrics, clinical assessment, EQ-5D-5L, IEXPAC, MEDAS dietary questionnaire) NIT-positive patients with VCTE ≥8.0 kPa → Hepatology physician consultation ± liver biopsy per clinical criteria

Histological sub-study: Liver biopsy specimens are scored using the NAFLD Activity Score (Kleiner 2005). At-risk MASH is defined as NAS ≥4 + fibrosis stage ≥F2. A target of approximately 300 evaluable biopsies is projected.

Lifestyle intervention sub-study: NIT-positive patients receive a single structured APN-delivered visit with a personalised SMART lifestyle protocol, with 24-week reassessment. Outcomes include changes in LSM, CAP, ALT, AST, GGT, HbA1c, FIB-4, and body composition (BIA).

Data management: REDCap electronic case report form, pseudonymised, restricted access.

Statistical approach: Prevalence with 95% CI (primary endpoint); AUROC with DeLong test for head-to-head NIT comparisons; sensitivity, specificity, PPV, NPV, LR+ and LR- for sequential algorithms; kappa for concordance. Health-economic analysis via CIBERehd.

Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease, Liver Fibrosis, Non-alcoholic Fatty Liver Disease NAFLD, Type 2 Diabetes Mellitus, Obesity, Obesity Type 2 Diabetes Mellitus
Keywords: MASLD, MAFLD, NAFLD, liver fibrosis, FIB-4, ELF, MASEF, screening, passive screening, advanced practice nurse, lifestyle intervention
Medical subject headings: Liver Cirrhosis, Diabetes Mellitus, Type 2, Obesity, Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07658755
Study group	Role	What they receive
NIT-Negative Cohort		High-risk patients (age 50-75 years with ≥1 metabolic risk criterion) in whom FIB-4 was automatically calculated by the LIS and found to be ≤1.30. These patients do not undergo further NIT evaluation and are followed as the non-exposed reference cohort.
NIT-Positive Cohort		High-risk patients with FIB-4 >1.30 in whom ELF and MASEF were reflexively determined from the same serum sample. Patients with ELF ≥9.8 or MASEF ≥0.33 are referred to the Hepatology Advanced Practice Nurse for VCTE (FibroScan) and clinical assessment.

What is being measured

The primary outcome is the main question the study is designed to answer.

Prevalence of hepatic fibrosis detected by the automated single-step case-finding strategy
Proportion of high-risk patients with a positive result on at least one confirmatory NIT (ELF ≥9.8, MASEF ≥0.33, or VCTE ≥8.0 kPa) among all patients in whom FIB-4 was automatically calculated by the LIS
Measured: Within 3 months of index blood test

Secondary outcomes (3)

Diagnostic accuracy of FIB-4+ELF versus FIB-4+MASEF for histologically-confirmed significant fibrosis (≥F2)
Head-to-head AUROC comparison (DeLong method) of sequential NIT algorithms at pre-specified thresholds (ELF ≥9.8; MASEF ≥0.33) in biopsied patients. Sensitivity, specificity, PPV, NPV reported.
Measured: At time of liver biopsy
Diagnostic accuracy of sequential NIT algorithms for at-risk MASH
AUROC comparison of FIB-4+ELF, FIB-4+MASEF, and FIB-4+FAST (threshold ≥0.50) for histological at-risk MASH (NAS ≥4 + fibrosis ≥F2, Kleiner criteria) in biopsied patients
Measured: At time of liver biopsy
Cost-effectiveness of the automated single-step strategy versus standard of care
Health-economic analysis: diagnostic yield per euro spent, cost per case detected, and cost per QALY gained
Measured: At study completion (September 2027)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20241 Sep 2027

First posted22 Jun 2026
Study start1 Oct 2024
Primary completion1 Jun 2027 (estimated)
Study completion1 Sep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Metabolic Dysfunction-Associated Steatotic 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: Prospective
Enrolment: 3,000 participants (estimated)
Target duration: 24 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT07658755
Sponsor's protocol ID: HEP-OSF2024
Other IDs: HEP-OSF2024
Acronym: LiverSeek
Status last verified: Jun 2026
First submitted: 14 Jun 2026
Last updated: 22 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data will not be shared publicly. Aggregate results will be disseminated via peer-reviewed publication and conference presentations. Data are held pseudonymised in REDCap under GDPR (EU 2016/679) and Spanish data protection law (LO 03/2018).

Publications

Graupera I, Thiele M, Castera L, Pera G, Piano S, Soria A, Fabrellas N, Toran P, Chacon C, Bech KT, Schnefeld HL, Tonon M, Incicco S, Moussy J, Levy V, Madir A, Kukic S, Jan Havaj D, Adamcova-Selcanova S, Pustjens J, van Kleef LA, Jimenez-Masip A, Pages L, Zoncape M, Weber SN, Galle PR, Harris R, Ibanez-Samaniego L, Morillas RM, Diaz A, Detlefsen S, Serra-Burriel M, Arslanow A, Andersen P, Pich J, Bonfill E, Korenjak M, Fournier-Poizat C, Llorca A, Gourmelon MC, de Koning HJ, Perez-Guasch M, Thu Ma A, Juanola A, Pose E, Arteaga I, Villesen I, Hansen JK, Calvino V, Gagliardi R, Boutouria B, Pastrovic F, Kujundzic PD, Zilincanova D, Sulejova KK, Rojo D, de Knegt RJ, Melo MD, Torrejon A, Hernandez-Ibanez R, Hoyo J, Munoz L, Lopez-Martos R, Griffin SJ, Manns M, Karlsen TH, Newsome PN, Kamath PS, Banares R, Guha IN, Schattenberg JM, Lammert F, Tsochatzis E, Brouwer WP, Pericas JM, Skladany L, Grgurevic I, Roulot D, Angeli P, Krag A, Caballeria L, Gines P; LiverScreen Consortium Investigators. Prevalence of liver fibrosis in the general population (the LiverScreen project): a multinational European cohort study. Lancet. 2026 Apr 11;407(10537):1448-1458. doi: 10.1016/S0140-6736(26)00354-5.
PubMed 41969010
Serra-Burriel M, Juanola A, Serra-Burriel F, Thiele M, Graupera I, Pose E, Pera G, Grgurevic I, Caballeria L, Piano S, van Kleef L, Reichert M, Roulot D, Pericas JM, Schattenberg JM, Tsochatztis EA, Guha IN, Garcia-Retortillo M, Hernandez R, Hoyo J, Fuentes M, Exposito C, Martinez A, Such P, Madir A, Detlefsen S, Tonon M, Martini A, Ma AT, Pich J, Bonfill E, Juan M, Soria A, Carol M, Gratacos-Gines J, Morillas RM, Toran P, Navarrete JM, Torrejon A, Fournier C, Llorca A, Arslanow A, de Koning HJ, Cucchietti F, Manns M, Newsome PN, Hernaez R, Allen A, Angeli P, de Knegt RJ, Karlsen TH, Galle P, Wong VW, Fabrellas N, Castera L, Krag A, Lammert F, Kamath PS, Gines P; LiverScreen Consortium Investigators. Development, validation, and prognostic evaluation of a risk score for long-term liver-related outcomes in the general population: a multicohort study. Lancet. 2023 Sep 16;402(10406):988-996. doi: 10.1016/S0140-6736(23)01174-1. Epub 2023 Aug 9.
PubMed 37572680
European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). J Hepatol. 2024 Sep;81(3):492-542. doi: 10.1016/j.jhep.2024.04.031. Epub 2024 Jun 7.
PubMed 38851997
Kjaergaard M, Lindvig KP, Thorhauge KH, Andersen P, Hansen JK, Kastrup N, Jensen JM, Hansen CD, Johansen S, Israelsen M, Torp N, Trelle MB, Shan S, Detlefsen S, Antonsen S, Andersen JE, Graupera I, Gines P, Thiele M, Krag A. Using the ELF test, FIB-4 and NAFLD fibrosis score to screen the population for liver disease. J Hepatol. 2023 Aug;79(2):277-286. doi: 10.1016/j.jhep.2023.04.002. Epub 2023 Apr 21.
PubMed 37088311
Noureddin M, Truong E, Mayo R, Martinez-Arranz I, Minchole I, Banales JM, Arrese M, Cusi K, Arias-Loste MT, Bruha R, Romero-Gomez M, Iruzubieta P, Aller R, Ampuero J, Calleja JL, Ibanez-Samaniego L, Aspichueta P, Martin-Duce A, Kushner T, Ortiz P, Harrison SA, Anstee QM, Crespo J, Mato JM, Sanyal AJ. Serum identification of at-risk MASH: The metabolomics-advanced steatohepatitis fibrosis score (MASEF). Hepatology. 2024 Jan 1;79(1):135-148. doi: 10.1097/HEP.0000000000000542. Epub 2023 Jul 24.
PubMed 37505221

Interested in taking part?

Luis Ibáñez-Samaniego, MD, PhD

+34 91 586 8308

luis.ibanez@salud.madrid.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Metabolic Dysfunction-Associated Steatotic Liver Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Towards Universal Screening for Metabolic Dysfunction-Associated Liver Fibrosis in Primary Care: Evaluation of a Single-Step, Laboratory Informatión System-Driven Automated Case-Finding Strategy (LiverSeek)
ClinicalTrials.gov ID: NCT07658755
Acronym / sponsor ID: LiverSeek / HEP-OSF2024
Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease, Liver Fibrosis, Non-alcoholic Fatty Liver Disease NAFLD, Type 2 Diabetes Mellitus, Obesity, Obesity Type 2 Diabetes Mellitus
Keywords: MASLD, MAFLD, NAFLD, liver fibrosis, FIB-4, ELF, MASEF, screening
Study type: Observational
Recruitment status: Recruiting
Enrolment: 3,000 participants (estimated)
Lead sponsor: Hospital General Universitario Gregorio MarañonUniversity, hospital or other
Collaborators: Instituto de Investigación Sanitaria Gregorio Marañón, Consorcio Centro de Investigación Biomédica en Red (CIBER)
Study start: 1 Oct 2024 (actual)
Primary completion: 1 Jun 2027 (estimated)
Study completion: 1 Sep 2027 (estimated)
First posted: 22 Jun 2026 (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.

Detailed description

NIT pathway and pre-specified thresholds:

Data management: REDCap electronic case report form, pseudonymised, restricted access.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 24 Months
Number of arms: 2

Arm	Type	Receives
NIT-Negative Cohort	–	–High-risk patients (age 50-75 years with ≥1 metabolic risk criterion) in whom FIB-4 was automatically calculated by the LIS and found to be ≤1.30. These patients do not undergo further NIT evaluation and are followed as the non-exposed reference cohort.
NIT-Positive Cohort	–	–High-risk patients with FIB-4 >1.30 in whom ELF and MASEF were reflexively determined from the same serum sample. Patients with ELF ≥9.8 or MASEF ≥0.33 are referred to the Hepatology Advanced Practice Nurse for VCTE (FibroScan) and clinical assessment.

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients attending primary care in peri-urban Madrid (SERMAS network) with metabolic risk factors for liver fibrosis, identified passively through routine laboratory data

Key inclusion criteria (6 listed)

Age between 50 and 75 years (inclusive)
Routine blood test processed in the Clinical Biochemistry Laboratory of Hospital General Universitario Gregorio Marañón, ordered by a primary care physician in one of the 11 affiliated SERMAS primary care centres
Presence of at least one of the following metabolic risk factor combinations:

Key exclusion criteria (3 listed)

Age <50 years or >75 years
Known pre-existing liver disease (significant or advanced fibrosis, cirrhosis, hepatocellular carcinoma, prior liver transplantation)
Prior fibrosis assessment within the preceding 12 months.

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

Prevalence of hepatic fibrosis detected by the automated single-step case-finding strategy
Time frame: Within 3 months of index blood test
Proportion of high-risk patients with a positive result on at least one confirmatory NIT (ELF ≥9.8, MASEF ≥0.33, or VCTE ≥8.0 kPa) among all patients in whom FIB-4 was automatically calculated by the LIS

3 secondary outcomes

Diagnostic accuracy of FIB-4+ELF versus FIB-4+MASEF for histologically-confirmed significant fibrosis (≥F2)
Time frame: At time of liver biopsy
Diagnostic accuracy of sequential NIT algorithms for at-risk MASH
Time frame: At time of liver biopsy
Cost-effectiveness of the automated single-step strategy versus standard of care
Time frame: At study completion (September 2027)

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 22 Jun 2026.
Background: PubMed 41969010Graupera I, Thiele M, Castera L, Pera G, Piano S, Soria A, Fabrellas N, Toran P, Chacon C, Bech KT, Schnefeld HL, Tonon M, Incicco S, Moussy J, Levy V, Madir A, Kukic S, Jan Havaj D, Adamcova-Selcanova S, Pustjens J, van Kleef LA, Jimenez-Masip A, Pages L, Zoncape M, Weber SN, Galle PR, Harris R, Ibanez-Samaniego L, Morillas RM, Diaz A, Detlefsen S, Serra-Burriel M, Arslanow A, Andersen P, Pich J, Bonfill E, Korenjak M, Fournier-Poizat C, Llorca A, Gourmelon MC, de Koning HJ, Perez-Guasch M, Thu Ma A, Juanola A, Pose E, Arteaga I, Villesen I, Hansen JK, Calvino V, Gagliardi R, Boutouria B, Pastrovic F, Kujundzic PD, Zilincanova D, Sulejova KK, Rojo D, de Knegt RJ, Melo MD, Torrejon A, Hernandez-Ibanez R, Hoyo J, Munoz L, Lopez-Martos R, Griffin SJ, Manns M, Karlsen TH, Newsome PN, Kamath PS, Banares R, Guha IN, Schattenberg JM, Lammert F, Tsochatzis E, Brouwer WP, Pericas JM, Skladany L, Grgurevic I, Roulot D, Angeli P, Krag A, Caballeria L, Gines P; LiverScreen Consortium Investigators. Prevalence of liver fibrosis in the general population (the LiverScreen project): a multinational European cohort study. Lancet. 2026 Apr 11;407(10537):1448-1458. doi: 10.1016/S0140-6736(26)00354-5.
Background: PubMed 37572680Serra-Burriel M, Juanola A, Serra-Burriel F, Thiele M, Graupera I, Pose E, Pera G, Grgurevic I, Caballeria L, Piano S, van Kleef L, Reichert M, Roulot D, Pericas JM, Schattenberg JM, Tsochatztis EA, Guha IN, Garcia-Retortillo M, Hernandez R, Hoyo J, Fuentes M, Exposito C, Martinez A, Such P, Madir A, Detlefsen S, Tonon M, Martini A, Ma AT, Pich J, Bonfill E, Juan M, Soria A, Carol M, Gratacos-Gines J, Morillas RM, Toran P, Navarrete JM, Torrejon A, Fournier C, Llorca A, Arslanow A, de Koning HJ, Cucchietti F, Manns M, Newsome PN, Hernaez R, Allen A, Angeli P, de Knegt RJ, Karlsen TH, Galle P, Wong VW, Fabrellas N, Castera L, Krag A, Lammert F, Kamath PS, Gines P; LiverScreen Consortium Investigators. Development, validation, and prognostic evaluation of a risk score for long-term liver-related outcomes in the general population: a multicohort study. Lancet. 2023 Sep 16;402(10406):988-996. doi: 10.1016/S0140-6736(23)01174-1. Epub 2023 Aug 9.
Background: PubMed 38851997European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). J Hepatol. 2024 Sep;81(3):492-542. doi: 10.1016/j.jhep.2024.04.031. Epub 2024 Jun 7.
Background: PubMed 37088311Kjaergaard M, Lindvig KP, Thorhauge KH, Andersen P, Hansen JK, Kastrup N, Jensen JM, Hansen CD, Johansen S, Israelsen M, Torp N, Trelle MB, Shan S, Detlefsen S, Antonsen S, Andersen JE, Graupera I, Gines P, Thiele M, Krag A. Using the ELF test, FIB-4 and NAFLD fibrosis score to screen the population for liver disease. J Hepatol. 2023 Aug;79(2):277-286. doi: 10.1016/j.jhep.2023.04.002. Epub 2023 Apr 21.
Background: PubMed 37505221Noureddin M, Truong E, Mayo R, Martinez-Arranz I, Minchole I, Banales JM, Arrese M, Cusi K, Arias-Loste MT, Bruha R, Romero-Gomez M, Iruzubieta P, Aller R, Ampuero J, Calleja JL, Ibanez-Samaniego L, Aspichueta P, Martin-Duce A, Kushner T, Ortiz P, Harrison SA, Anstee QM, Crespo J, Mato JM, Sanyal AJ. Serum identification of at-risk MASH: The metabolomics-advanced steatohepatitis fibrosis score (MASEF). Hepatology. 2024 Jan 1;79(1):135-148. doi: 10.1097/HEP.0000000000000542. Epub 2023 Jul 24.
Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. Aggregate results will be disseminated via peer-reviewed publication and conference presentations. Data are held pseudonymised in REDCap under GDPR (EU 2016/679) and Spanish data protection law (LO 03/2018).

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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.

Luis Ibáñez-Samaniego, MD, PhD contact

+34 91 586 8308

luis.ibanez@salud.madrid.org

Rafael Bañares, Full-Professor of Medicine study chair

Universidad Complutense de Madrid, President of Spanish Association for the Study of the Liver (AEEH)

Magdalena Salcedo, MD, PhD study chair

President of the Spanish Society of Liver Transplantation (SETH)

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 Metabolic Dysfunction-Associated Steatotic Liver Disease and Liver Fibrosis, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.

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 3 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 22 Jun 2026. 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 Spain. 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 Luis Ibáñez-Samaniego, MD, PhD (+34 91 586 8308, luis.ibanez@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of hepatic fibrosis detected by the automated single-step case-finding strategy (time frame: Within 3 months of index blood test). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07658755, which also lists 5 linked publications.

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 22 Jun 2026.