Bone Marrow FibrosisNCT07853417
Special Stains in Assessment of Bone Marrow Fibrosis
An observational study of Bone Marrow Fibrosis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Marrow Fibrosis
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2026to 10 Feb 2028
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Bone marrow trephine biopsy specimens with suspected or established marrow fibrosis processed at South Egypt Cancer Institute, Assiut University.
Who may be able to join
- - 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
Who cannot join
- - Inadequate, fragmented, poorly fixed, or autolyzed tissue
- Unsuitable paraffin blocks due to processing artifacts
- Missing or insufficient clinical or pathological data required for analysis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bone Marrow Fibrosis
- Keywords
- Bone marrow fibrosis, Assiut, Picrosirius Red, Masson's Trichrome, Reticulin stain
- Medical subject headings
- Primary Myelofibrosis
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Mean reticulin fibrosis grade
Mean reticulin fibrosis grade according to the European consensus MF-0 to MF-3 system.
Measured: Baseline
Secondary outcomes (4)
Mean collagen deposition grade by Masson's Trichrome
Mean semiquantitative grade of collagen deposition assessed by Masson's Trichrome stain.
Measured: Baseline
Mean collagen deposition grade by Picrosirius Red
Mean semiquantitative grade of collagen deposition assessed by Picrosirius Red stain.
Measured: Baseline
Proportion of specimens with MF-3 fibrosis
Proportion of bone marrow specimens graded as MF-3 by reticulin stain.
Measured: Baseline
Proportion of specimens with concordant grades between Reticulin and Picrosirius Red
Proportion of specimens showing concordant fibrosis grades between Reticulin and Picrosirius Red stains.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start26 Sep 2026 (estimated)
- Primary completion26 Sep 2027 (estimated)
- Study completion10 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow FibrosisStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Mahmoud Fathallah Ahmed, Assiut University
- Investigators
- Eman M Zaki, prof, Study chair, Oncological Clinical Pathology Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853417
- Sponsor's protocol ID
- BMF-Stains-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No