- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07785726
Clinical, Hematological and Pathological Profile of Pancytopenia
Clinical, Hematological and Pathological Profile of Pancytopenia Cases in Assiut University Hospitals
연구 개요
상태
정황
상세 설명
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
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: rana mohamed zain, MBBCh
- 전화번호: +201026597669
- 이메일: ranahafez119@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of underlying etiologies of pancytopenia
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frequency of clinical features and hematological parameters in pancytopenia patients
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 연구 의자: Mai Mostafa mohamed kamal, Prof, Assiut University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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