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Not yet recruitingNCT07872059MASLDUpdated Oct 13, 2026

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 in MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Assiut University · Observational

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

Keywords

  • MASLD
03

In context

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

El-Raghy Hospital patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • MASLD patients
06

What researchers measure

Primary outcomes

  1. • 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.

    Time frame: Baseline (at the index CBC assessment corresponding to MASLD diagnosis for cases and the corresponding index CBC assessment for controls).

Secondary outcomes

  1. · To determine the difference in prevalence of other hematological abnormalities, including anemia, neutropenia, thrombocytosis, and any complete blood count (CBC) abnormality

    Time frame: Baseline (at the index CBC assessment corresponding to MASLD diagnosis for cases and the corresponding index CBC assessment for controls)

  2. · To assess the association between hematological abnormalities and demographic and clinical characteristics

    Time frame: Baseline (at the index assessment corresponding to the CBC assessment for cases and the corresponding index assessment for controls).

  3. · 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)

    Time frame: Baseline (using laboratory data corresponding to the index CBC assessment for cases and the corresponding index assessment for controls).

07

Study locations

No study locations are listed for this record.

08

References and documents

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 41987810 ↗
  • Krintus 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 41631709 ↗
  • Chen 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 39470560 ↗
  • Tsai 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 41180506 ↗
  • Miller 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 41255342 ↗
  • Zeng 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 41024003 ↗
  • Huang 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 ↗

Study documents

  • Protocol and statistical analysis plan · Oct 7, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2026
First posted
Oct 13, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
May 1, 2027
CompletionEst.
Oct 1, 2027
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07872059
Lead sponsor
Assiut University
Responsible party
Mohamed Gamal Sayed Mohamed (Resident physician at internal medicine department, Assiut university, Egypt, Assiut University) — Principal investigator
First posted
Oct 13, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
May 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Oct 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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