Clinical, Hematological and Pathological Profile of Pancytopenia

August 22, 2026 updated by: Rana Mohamed Zain, Assiut University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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:

  1. Clinical Assessment: Gathering comprehensive demographic data, clinical history, and physical examination findings (e.g., pallor, splenomegaly, hepatomegaly, lymphadenopathy).
  2. Hematological Profiling: Reviewing complete blood count (CBC) parameters, peripheral blood smear findings, and reticulocyte counts.
  3. 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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients of different age groups and both sexes who present with clinical manifestations and laboratory findings suggestive of pancytopenia, attending the inpatient departments or outpatient clinics at Assiut University Hospitals.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Pancytopenia Cases
Patients presenting with clinical and laboratory features of pancytopenia who are admitted to or evaluated at Assiut University Hospitals. This group includes individuals undergoing routine clinical, hematological, and pathological assessments to identify the underlying causes of their condition.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At the time of patient enrollment and initial diagnostic workup

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
At baseline
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 )
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mai Mostafa mohamed kamal, Prof, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pancytopenia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data will not be shared to protect patient privacy and maintain confidentiality in accordance with the institutional ethical guidelines of Assiut University. Only aggregate study results and statistical summaries will be available through publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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