MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)MASLDNCT07872059
Prevalence and Clinical Significance of Hematological Abnormalities in Patients With Clinically Diagnosed Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Case-Control Study
An observational study of MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), run by Assiut University.
Trial summary
this study aims to investigate the prevalence of hematological abnormalities among patients with clinically diagnosed MASLD, evaluate their clinical correlates, and examine their association with non-invasive fibrosis scores. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Oct 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: El-Raghy Hospital patients
Who may be able to join
- Adults aged ≥18 years.
- Patients with a clinical diagnosis of MASLD based on fibroscan records.
- Availability of complete blood count (CBC) data.
- Availability of relevant demographic and clinical information.
Who cannot join
- Age below 18 years.
- Alcoholic liver disease.
- Viral hepatitis.
- Autoimmune liver diseases.
- Other chronic liver diseases or secondary causes of hepatic steatosis.
- Patients with unavailable essential laboratory or clinical data.
About this study
this study aims to investigate the prevalence of hematological abnormalities among patients with clinically diagnosed MASLD, evaluate their clinical correlates, and examine their association with non-invasive fibrosis scores. The findings may improve risk stratification and facilitate early identification of patients who require closer monitoring or further hepatological assessment.
Read the detailed description
Metabolic dysfunction-associated steatotic liver disease (MASLD), previously known as non-alcoholic fatty liver disease (NAFLD), is one of the most prevalent chronic liver diseases worldwide, with its burden increasing in parallel with obesity, type 2 diabetes mellitus, and metabolic syndrome. Progressive forms of MASLD may lead to advanced fibrosis, cirrhosis, hepatocellular carcinoma, and liver-related complications. Beyond hepatic injury, MASLD is increasingly recognized as a multisystem disorder associated with extrahepatic manifestations.
Hematological abnormalities, including anemia, neutropenia, and platelet abnormalities, have been reported in patients with chronic liver disease. These abnormalities may be related to chronic inflammation, hypersplenism, nutritional deficiencies, bone marrow suppression, or impaired thrombopoietin production. Platelet count is also incorporated into commonly used non-invasive fibrosis scores, including the Fibrosis-4 (FIB-4) index and the Aspartate Aminotransferase-to-Platelet Ratio Index (APRI).
Although hematological parameters are routinely available through complete blood count (CBC) testing, the prevalence and clinical significance of CBC abnormalities among patients with clinically diagnosed MASLD remain insufficiently characterized. Evaluating these abnormalities may provide additional information for clinical risk stratification and identification of patients who may require further hepatological assessment.
- Keywords
- MASLD
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 |
|---|---|---|
| MASLD patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
• To determine the difference in prevalence of thrombocytopenia between cases and controls
To determine the difference in prevalence of thrombocytopenia between patients with clinically diagnosed metabolic dysfunction-associated steatotic liver disease (MASLD) and control participants.
Measured: Baseline (at the index CBC assessment corresponding to MASLD diagnosis for cases and the corresponding index CBC assessment for controls).
Secondary outcomes (3)
· To determine the difference in prevalence of other hematological abnormalities, including anemia, neutropenia, thrombocytosis, and any complete blood count (CBC) abnormality
Measured: Baseline (at the index CBC assessment corresponding to MASLD diagnosis for cases and the corresponding index CBC assessment for controls)
· To assess the association between hematological abnormalities and demographic and clinical characteristics
Measured: Baseline (at the index assessment corresponding to the CBC assessment for cases and the corresponding index assessment for controls).
· To evaluate the relationship between CBC abnormalities and non-invasive liver fibrosis scores, including the Fibrosis-4 Index (FIB-4) and the Aspartate Aminotransferase-to-Platelet Ratio Index (APRI)
Measured: Baseline (using laboratory data corresponding to the index CBC assessment for cases and the corresponding index assessment for controls).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal Sayed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872059
- Sponsor's protocol ID
- CBC abnormalities in MASLD
- Acronym
- MASLD
- Status last verified
- Oct 2026
- First submitted
- 4 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang L, Wang Y. Non-Invasive Tests for the Detection of MASLD: Biomarkers and Imaging for Staging Steatosis, MASH, and Fibrosis. Int J Gen Med. 2026 Apr 9;19:593387. doi: 10.2147/IJGM.S593387. eCollection 2026.
PubMed 41987810Krintus M, Panteghini M. Detection of Advanced Liver Fibrosis Using Blood Noninvasive Tests: A Laboratory Medicine Perspective. Clin Chem. 2026 Mar 5;72(3):337-346. doi: 10.1093/clinchem/hvaf193.
PubMed 41631709Chen M, Guo C, Ouyang K, Liu N. Diagnostic role of the fibrosis-4 index and nonalcoholic fatty liver disease fibrosis score as a noninvasive tool for liver fibrosis scoring. Medicine (Baltimore). 2024 Oct 25;103(43):e40214. doi: 10.1097/MD.0000000000040214.
PubMed 39470560Tsai CH, Hung TH, Wong TS, Lin CY, Hsu CL, Ko PH, Chou YC, Li HF, Chien SH, Hsu CS. Extrahepatic manifestations of metabolic dysfunction-associated steatotic liver disease: An updated clinical overview. Tzu Chi Med J. 2025 Jul 23;37(4):378-385. doi: 10.4103/tcmj.tcmj_158_25. eCollection 2025 Oct-Dec.
PubMed 41180506Miller DM, McCauley KF, Dunham-Snary KJ. Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): Mechanisms, Clinical Implications and Therapeutic Advances. Endocrinol Diabetes Metab. 2025 Nov;8(6):e70132. doi: 10.1002/edm2.70132.
PubMed 41255342Zeng J, Gu C, Wen C, Shen C. The burden of NAFLD (now referred to as MASLD)-related chronic liver disease and cirrhosis from 1990 to 2021 with projections to 2036: a comparative study of global China the United States and India. Lipids Health Dis. 2025 Sep 29;24(1):298. doi: 10.1186/s12944-025-02750-z.
PubMed 41024003Huang DQ, Wong VWS, Rinella ME, Boursier J, Lazarus JV, Yki-Jarvinen H, Loomba R. Metabolic dysfunction-associated steatotic liver disease in adults. Nat Rev Dis Primers. 2025 Mar 6;11(1):14. doi: 10.1038/s41572-025-00599-1.
PubMed 40050362