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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Special Stains in Assessment of Bone Marrow Fibrosis
- ClinicalTrials.gov ID
- NCT07853417
- Acronym / sponsor ID
- BMF-Stains-Assiut-2026
- Conditions
- Bone Marrow Fibrosis
- Keywords
- Bone marrow fibrosis, Assiut, Picrosirius Red, Masson's Trichrome, Reticulin stain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Sep 2026 (estimated)
- Primary completion
- 26 Sep 2027 (estimated)
- Study completion
- 10 Feb 2028 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- - 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
Key exclusion criteria (3 listed)
- - Inadequate, fragmented, poorly fixed, or autolyzed tissue
- Unsuitable paraffin blocks due to processing artifacts
- Missing or insufficient clinical or pathological data required for analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean reticulin fibrosis grade
Time frame: Baseline
Mean reticulin fibrosis grade according to the European consensus MF-0 to MF-3 system.
4 secondary outcomes
Mean collagen deposition grade by Masson's Trichrome
Time frame: Baseline
Mean collagen deposition grade by Picrosirius Red
Time frame: Baseline
Proportion of specimens with MF-3 fibrosis
Time frame: Baseline
Proportion of specimens with concordant grades between Reticulin and Picrosirius Red
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Bone Marrow Fibrosis
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Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
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Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
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RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eman M Zaki, prof study chair
Oncological Clinical Pathology Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Marrow Fibrosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salma M Fathallah, Resident (01066296349, salma.18313350@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean reticulin fibrosis grade (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.