Special Stains in Assessment of Bone Marrow Fibrosis

NCT07853417 | Not Yet Recruiting

• 1 other identifier: BMF-Stains-Assiut-2026
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bone Marrow Fibrosis

Keywords

Bone marrow fibrosis; Assiut; Picrosirius Red; Masson's Trichrome; Reticulin stain

Outcome Measures

Primary Outcomes (1)

• Mean reticulin fibrosis grade

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

  Baseline

Secondary Outcomes (4)

• Mean collagen deposition grade by Masson's Trichrome

  Baseline

• Mean collagen deposition grade by Picrosirius Red

  Baseline

• Proportion of specimens with MF-3 fibrosis

  Baseline

• Proportion of specimens with concordant grades between Reticulin and Picrosirius Red

  Baseline

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Eman M Zaki, prof

  Oncological Clinical Pathology Department, Assiut University Hospitals

  STUDY CHAIR

Central Study Contacts

Salma M Fathallah, Resident

CONTACT

01066296349; salma.18313350@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Oncological Clinical Pathology

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 1, 2026
• Study Start: September 26, 2026
• Primary Completion (Estimated): September 26, 2027
• Study Completion (Estimated): February 10, 2028
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share