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- Essai clinique NCT07785726
Clinical, Hematological and Pathological Profile of Pancytopenia
Clinical, Hematological and Pathological Profile of Pancytopenia Cases in Assiut University Hospitals
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: rana mohamed zain, MBBCh
- Numéro de téléphone: +201026597669
- E-mail: ranahafez119@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of underlying etiologies of pancytopenia
Délai: At the time of patient enrollment and initial diagnostic workup
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Percentage of study participants diagnosed with each etiology of pancytopenia based on clinical, hematological, and pathological evaluation
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At the time of patient enrollment and initial diagnostic workup
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Frequency of clinical features and hematological parameters in pancytopenia patients
Délai: At baseline
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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).
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At baseline
|
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Distribution of bone marrow pathological findings
Délai: At baseline
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Percentage of patients categorized by bone marrow aspirate and biopsy findings (e.g., hypercellular, hypocellular, dysplastic changes )
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At baseline
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Mai Mostafa mohamed kamal, Prof, Assiut University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Pancytopenia
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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