Special Stains in Assessment of Bone Marrow Fibrosis

September 26, 2026 updated by: Salma Mahmoud Fathallah Ahmed, Assiut University

Comparative Evaluation of Special Stains in Assessment of Bone Marrow Fibrosis

This cross-sectional study aims to compare Picrosirius Red, Masson's Trichrome, and Reticulin stains for the detection and assessment of bone marrow fibrosis in trephine biopsy specimens.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Bone marrow fibrosis is assessed using special stains that highlight reticulin and collagen fibers. This observational study will evaluate formalin-fixed paraffin-embedded bone marrow trephine biopsy specimens.

Three serial sections from each specimen will be stained with Reticulin, Masson's Trichrome, and Picrosirius Red. Fibrosis will be graded using the MF-0 to MF-3 system, and findings will be compared across the three staining methods.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Bone marrow trephine biopsy specimens with suspected or established marrow fibrosis processed at South Egypt Cancer Institute, Assiut University.

Description

Inclusion Criteria:

  • - Adequate bone marrow trephine biopsy tissue with sufficient well-fixed, well-preserved paraffin-embedded material for all required stains
  • Cases with suspected or established marrow fibrosis and variable degrees of fibrosis
  • Availability of relevant clinical and pathological information

Exclusion Criteria:

  • - Inadequate, fragmented, poorly fixed, or autolyzed tissue
  • Unsuitable paraffin blocks due to processing artifacts
  • Missing or insufficient clinical or pathological data required for analysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: CASE_ONLY
  • Time Perspectives: CROSS_SECTIONAL

Cohorts and Interventions

Group / Cohort
Single cohort: Bone Marrow Biopsy Specimens

Formalin-fixed paraffin-embedded bone marrow trephine biopsy specimens that will be stained with Reticulin, Masson's Trichrome, and Picrosirius Red for fibrosis assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean reticulin fibrosis grade
Time Frame: Baseline

Mean reticulin fibrosis grade according to the European consensus MF-0 to MF-3 system.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean collagen deposition grade by Masson's Trichrome
Time Frame: Baseline

Mean semiquantitative grade of collagen deposition assessed by Masson's Trichrome stain.
Baseline
Mean collagen deposition grade by Picrosirius Red
Time Frame: Baseline

Mean semiquantitative grade of collagen deposition assessed by Picrosirius Red stain.
Baseline
Proportion of specimens with MF-3 fibrosis
Time Frame: Baseline

Proportion of bone marrow specimens graded as MF-3 by reticulin stain.
Baseline
Proportion of specimens with concordant grades between Reticulin and Picrosirius Red
Time Frame: Baseline

Proportion of specimens showing concordant fibrosis grades between Reticulin and Picrosirius Red stains.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Eman M Zaki, prof, Oncological Clinical Pathology Department, Assiut University Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 26, 2026

Primary Completion (Estimated)

September 26, 2027

Study Completion (Estimated)

February 10, 2028

Study Registration Dates

First Submitted

September 26, 2026

First Submitted That Met QC Criteria

September 26, 2026

First Posted (Actual)

October 1, 2026

Study Record Updates

Last Update Posted (Actual)

October 1, 2026

Last Update Submitted That Met QC Criteria

September 26, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMF-Stains-Assiut-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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