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NCT Number: NCT07785726

Clinical, Hematological and Pathological Profile of Pancytopenia

Describe clinical characteristic, peripheral blood parameters and bone marrow examination in pancytopenia patients and Analyze etiology of pancytopenia and study the outcomes regarding duration of hospital stay.

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Key information

Sex eligibility

All sexes

Study type

Observational

About this study

Pancytopenia is not a disease entity but a triad of finding - that may result from several disease processes and is defined as the simultaneous presence of anemia, leucopenia, and thrombocytopenia.

Bone marrow aspiration along with trephine biopsy is important to find pancytopenia etiological backgroind. Physical findings and peripheral blood picture of pancytopenia patients and help in planning investigations on bone marrow samples. The etiology of pancytopenia can thus be established after correlation of the clinical details with the laboratory investigations.

The cause of pancytopenia can be a) ineffective hematopoiesis with cell death in bone marrow, (b) formation of defective cells which are rapidly removed from circulations, (c) sequestration and/or destruction of cells by the action of antibodies or (d) trapping of normal cells in a hypertrophied and over-reactive reticuloendothelial system. The pattern of diseases leading to pancytopenia is expected to vary in different population groups with their difference in age pattern, nutritional status, and prevalence of infective disorders. Pancytopenia remains a challenging clinical entity with a wide spectrum of etiologies, ranging from benign nutritional deficiencies to malignant bone marrow disorders.

This study will be conducted as an observational, descriptive hospital-based study at Assiut University Hospitals. The investigators will collect data from patients presenting with clinical and laboratory features of pancytopenia.

The primary objectives and methodologies include:

  • Clinical Assessment: Gathering comprehensive demographic data, clinical history, and physical examination findings (e.g., pallor, splenomegaly, hepatomegaly, lymphadenopathy).
  • Hematological Profiling: Reviewing complete blood count (CBC) parameters, peripheral blood smear findings, and reticulocyte counts.
  • Pathological Evaluation: Analyzing bone marrow aspiration and/or bone marrow biopsy findings to identify the definitive underlying cause of the pancytopenia (such as megaloblastic anemia, aplastic anemia, or hematological malignancies).

By correlating the clinical presentation with hematological and pathological findings, this study will establish a comprehensive profile of pancytopenia cases in Upper Egypt, contributing to better diagnostic protocols and patient care

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged ≥ 18 years suffering from pancytopenia. Pancytopenia defined as a hematologic condition characterized by a decrease in all three peripheral blood cell lines. It is characterized by a hemoglobin value of less than 12 g/dL in women and 13 g/dL in men, platelets of less than 150,000 per mcL, and leukocytes of less than 4000 per ml (or absolute neutrophil count of less than 1800 per ml), (Chiravuri, Shalini, and Orlando De Jesus. "Pancytopenia.". StatPearls Publishing, 2023).

-Exclusion criteria: Patients aged less than 18 years old. Patients refused to participate in the study. Patients not fit for BM biopsy

Treatment and study plan

Primary outcomes

  1. Proportion of underlying etiologies of pancytopenia

    Time frame: At the time of patient enrollment and initial diagnostic workup

    Percentage of study participants diagnosed with each etiology of pancytopenia based on clinical, hematological, and pathological evaluation

Secondary outcomes

  1. Frequency of clinical features and hematological parameters in pancytopenia patients

    Time frame: At baseline

    Percentage of patients presenting with specific clinical symptoms (e.g., pallor, bleeding, fever) and distribution of CBC findings (e.g., hemoglobin levels, absolute neutrophil count, platelet count).

  2. Distribution of bone marrow pathological findings

    Time frame: At baseline

    Percentage of patients categorized by bone marrow aspirate and biopsy findings (e.g., hypercellular, hypocellular, dysplastic changes )

Study contacts

Contact information is provided by the study sponsor or research team.

rana mohamed zain, MBBCh

CONTACT

[email protected]

+201026597669

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Clinical, Hematological and Pathological Profile of Pancytopenia Cases in Assiut University Hospitals

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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