PancytopeniaNCT07785726
Clinical, Hematological and Pathological Profile of Pancytopenia
An observational study of Pancytopenia, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancytopenia
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Oct 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: 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.
Who may be able to join
- 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
Who cannot join
None listed.
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: 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.
Read the 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:
- 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
- Conditions
- Pancytopenia
- Keywords
- pancytopenia
- Medical subject headings
- Pancytopenia
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Proportion of underlying etiologies of pancytopenia
Percentage of study participants diagnosed with each etiology of pancytopenia based on clinical, hematological, and pathological evaluation
Measured: At the time of patient enrollment and initial diagnostic workup
Secondary outcomes (2)
Frequency of clinical features and hematological parameters in pancytopenia patients
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).
Measured: At baseline
Distribution of bone marrow pathological findings
Percentage of patients categorized by bone marrow aspirate and biopsy findings (e.g., hypercellular, hypocellular, dysplastic changes )
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancytopeniaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Mohamed Zain, Assiut University
- Investigators
- Mai Mostafa mohamed kamal, Prof, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785726
- Sponsor's protocol ID
- Pancytopenia
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Hematological and Pathological Profile of Pancytopenia Cases in Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT07785726
- Acronym / sponsor ID
- Pancytopenia
- Conditions
- Pancytopenia
- Keywords
- pancytopenia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 25 Aug 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.
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.
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:
- 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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
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
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
2 secondary outcomes
Frequency of clinical features and hematological parameters in pancytopenia patients
Time frame: At baseline
Distribution of bone marrow pathological findings
Time frame: At 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 25 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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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.
Mai Mostafa mohamed kamal, Prof study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Pancytopenia, 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 2 inclusion and 0 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 25 Aug 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 rana mohamed zain, MBBCh (+201026597669, ranahafez119@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of underlying etiologies of pancytopenia (time frame: At the time of patient enrollment and initial diagnostic workup). 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 25 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.