Currently submitted to: JMIR Research Protocols
Date Submitted: Sep 28, 2026
Open Peer Review Period: Sep 29, 2026 - Nov 24, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Protocol Utility of Peripheral Blood Smear, Bone Marrow Aspiration, Bone Marrow Trephine Biopsy and Immunohistochemistry in the Diagnosis of Haematological Neoplasms: Protocol for a Prospective Hospital-Based Cross-Sectional Diagnostic Study
ABSTRACT
Background:
Haematological neoplasms comprise heterogeneous myeloid, lymphoid, plasma-cell, histiocytic and dendritic-cell disorders. Diagnosis commonly requires integration of clinical findings with peripheral blood morphology, bone marrow cytology, marrow architecture and immunophenotypic findings. In rural and resource-constrained settings, peripheral blood smear (PBS), bone marrow aspiration (BMA), bone marrow trephine biopsy (BMB) and immunohistochemistry (IHC) remain important components of the diagnostic pathway.
Objective:
To study and compare the diagnostic utility of PBS, BMA, BMB and IHC for identifying and classifying haematological neoplasms, including their diagnostic yield, concordance, discordance, incremental contribution and diagnostic accuracy where an appropriate reference diagnosis can be defined.
Methods:
This prospective, hospital-based, cross-sectional, observational diagnostic study will enrol 66 participants with clinical suspicion of a haematological neoplasm. Participants will undergo clinical assessment and complete blood count followed by PBS examination and, where clinically indicated and technically feasible, BMA, BMB and disease-directed IHC. Findings will be recorded using a structured proforma. Diagnostic yield, concordance and discordance will be assessed. Where a prespecified reference diagnosis permits calculation, sensitivity, specificity, positive predictive value and negative predictive value will be estimated with 95% confidence intervals. Agreement between categorical classifications will be assessed using Cohen kappa, with paired comparisons considered where appropriate. Missing, inadequate and indeterminate results will be reported separately.
Results:
At protocol submission in September 2026, the study is planned for recruitment during 2026–2028 and no substantive participant-level outcome results are available. The protocol prespecifies the diagnostic workflow, outcomes, reference-diagnosis approach, analysis plan and anticipated sources of bias.
Conclusions:
The study is designed to characterise the complementary diagnostic contributions of PBS, BMA, BMB and IHC in a rural hospital-based setting while transparently addressing specimen inadequacy, conditional testing and potential verification and incorporation bias. Clinical Trial: Clinical Trials Registry–India (CTRI): CTRI/2026/07/115001
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