PancytopeniaNCT03521947
Management of Childhood Pancytopenia
An observational study of Pancytopenia, run by Assiut University.
Trial summary
Pancytopenia is an important hematologic Problem.it is a decrease in all three cellular elements of peripheral blood leading to aneamia, leucopenia and thrombocytopenia. Read more about this study
- Who is it for?
- Ages 4 weeks to 18 years
- Conditions the study is for
- Pancytopenia
- What is being tested?
- Complete blood picture
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2018to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 4 weeks to 18 years
- All sexes
- Child, Adult
Study population: Childrens and adolescents from age one month up to 18 years old suffering from pancytopenia.
Who may be able to join
- All childrens and adolescents suffering from pancytopenia attending heamatology unit of pediatric department Assiut University Hospital will be included.
Who cannot join
- childrens and adolescents suffering from pancytopenia due to malignancy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Management of Childhood Pancytopenia in Heamatology Unit in Assiut University Hospital
Pancytopenia is an important hematologic Problem.it is a decrease in all three cellular elements of peripheral blood leading to aneamia, leucopenia and thrombocytopenia.
Read the detailed description
Pancytopenia usually presents with symptoms of bone marrow failure such as pallor, dysnea, brusing and increased tendency to infections.
The incidence of various disorders causing pancytopenia varies according to Geographical distribution and genetic mutations. It can result from :
- Failure of production of hematopoietic progenitors in bone marrow as in aplastic aneamia.
- Bone marrow infiltration by malignant cells as in acute leukemia.
- Antibodies mediated bone marrow suppression as in systemic lupus.
- Ineffective hematopoiesis and dysplasia as in nutrition deficiency.
- Peripheral sequestration of blood cells in over active reticuloendothelial system as in hypersplenism.
Pancytopenia is not a disease entity but a triad of findings that may result from primary or secondary bone marrow involvement.
Bone marrow aspiration and biopsy evaluation along with clinical correlation are important to evaluate the causes of pancytopenia and plan further investigations and treatment.
Pancytopenia can result from damage to bone marrow evidanced by low reticulocyte count, or increased destruction of the peripheral blood with increased reticulocyte count.
Bone marrow examination is a simple and safe invasive procedure for evaluating the causes of pancytopenia.
The hypoplastic marrow which occurs in 2% of pediatrics acute lymphoblastic leukemia may be misdiagnosed as aplastic aneamia.
Studies done have shown leukemia to be the second most common cause of pancytopenia in pediatrics, marginally behind aplastic aneamia.
- Conditions
- Pancytopenia
- Being tested
- Complete blood picture
- Keywords
- MCP
- Medical subject headings
- Pancytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete blood pictureDiagnostic test
Iaboratory investigation
| Study group | Role | What they receive |
|---|---|---|
| One group of children below 18 years old | Not described Receives: Diagnostic Test: Complete blood picture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Availability
Bone marrow examination for all cases [evaluate the causes of pancytopenia and plan further investigations and treatment.]
Measured: One year
Secondary outcomes (1)
Modification
Guidelines for management of pancytopenia modified or not? [Strategy of blood elements transfusion in treatment]
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Jun 2018 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Otify, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521947
- Sponsor's protocol ID
- MCP
- Status last verified
- May 2018
- First submitted
- 17 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hayat,A.S, Khan,A.H,GH and Shaikh, N . (2014). Pancytopenia :study for clinical features and Etiological pattern at a tertiary care settings in Abbottabad.The professional medical journal, 21,060-065.
Raja S, Suman FR, Scott JX, Latha MS, Rajenderan A, Ethican A. Pancytopenia - (?) An obstacle in the diagnosis and outcome of pediatric acute lymphoblastic leukemia. South Asian J Cancer. 2015 Apr-Jun;4(2):68-71. doi: 10.4103/2278-330X.155648.
PubMed 25992344Desalphine M, Bagga PK, Gupta PK, Kataria AS. To evaluate the role of bone marrow aspiration and bone marrow biopsy in pancytopenia. J Clin Diagn Res. 2014 Nov;8(11):FC11-5. doi: 10.7860/JCDR/2014/9042.5169. Epub 2014 Nov 20.
PubMed 25584228Al-Khalisi, K.A,Al-zubaidy, A. S and Rhaima. M. 2011.Pancytopenia adult patients atBaghdad Teatching Hospital. The Iraqi postgraduate medical journals, 10,441-448
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Childhood Pancytopenia in Heamatology Unit in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT03521947
- Acronym / sponsor ID
- MCP
- Conditions
- Pancytopenia
- Keywords
- MCP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 11 May 2018 (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.
Pancytopenia is an important hematologic Problem.it is a decrease in all three cellular elements of peripheral blood leading to aneamia, leucopenia and thrombocytopenia.
Detailed description
Pancytopenia usually presents with symptoms of bone marrow failure such as pallor, dysnea, brusing and increased tendency to infections.
The incidence of various disorders causing pancytopenia varies according to Geographical distribution and genetic mutations. It can result from :
- Failure of production of hematopoietic progenitors in bone marrow as in aplastic aneamia.
- Bone marrow infiltration by malignant cells as in acute leukemia.
- Antibodies mediated bone marrow suppression as in systemic lupus.
- Ineffective hematopoiesis and dysplasia as in nutrition deficiency.
- Peripheral sequestration of blood cells in over active reticuloendothelial system as in hypersplenism.
Pancytopenia is not a disease entity but a triad of findings that may result from primary or secondary bone marrow involvement.
Bone marrow aspiration and biopsy evaluation along with clinical correlation are important to evaluate the causes of pancytopenia and plan further investigations and treatment.
Pancytopenia can result from damage to bone marrow evidanced by low reticulocyte count, or increased destruction of the peripheral blood with increased reticulocyte count.
Bone marrow examination is a simple and safe invasive procedure for evaluating the causes of pancytopenia.
The hypoplastic marrow which occurs in 2% of pediatrics acute lymphoblastic leukemia may be misdiagnosed as aplastic aneamia.
Studies done have shown leukemia to be the second most common cause of pancytopenia in pediatrics, marginally behind aplastic aneamia.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group of children below 18 years old | – | Diagnostic Test: Complete blood picture |
Who may qualify
- Ages
- 4 weeks to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Childrens and adolescents from age one month up to 18 years old suffering from pancytopenia.
Key inclusion criteria (1 listed)
- All childrens and adolescents suffering from pancytopenia attending heamatology unit of pediatric department Assiut University Hospital will be included.
Key exclusion criteria (1 listed)
- childrens and adolescents suffering from pancytopenia due to malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete blood pictureIaboratory investigation | Diagnostic test | One group of children below 18 years old |
Primary outcome
Availability
Time frame: One year
Bone marrow examination for all cases [evaluate the causes of pancytopenia and plan further investigations and treatment.]
1 secondary outcome
Modification
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- BackgroundHayat,A.S, Khan,A.H,GH and Shaikh, N . (2014). Pancytopenia :study for clinical features and Etiological pattern at a tertiary care settings in Abbottabad.The professional medical journal, 21,060-065.
- Background: PubMed 25992344Raja S, Suman FR, Scott JX, Latha MS, Rajenderan A, Ethican A. Pancytopenia - (?) An obstacle in the diagnosis and outcome of pediatric acute lymphoblastic leukemia. South Asian J Cancer. 2015 Apr-Jun;4(2):68-71. doi: 10.4103/2278-330X.155648.
- Background: PubMed 25584228Desalphine M, Bagga PK, Gupta PK, Kataria AS. To evaluate the role of bone marrow aspiration and bone marrow biopsy in pancytopenia. J Clin Diagn Res. 2014 Nov;8(11):FC11-5. doi: 10.7860/JCDR/2014/9042.5169. Epub 2014 Nov 20.
- BackgroundAl-Khalisi, K.A,Al-zubaidy, A. S and Rhaima. M. 2011.Pancytopenia adult patients atBaghdad Teatching Hospital. The Iraqi postgraduate medical journals, 10,441-448
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Gadelrab Askr, Professor (01114064050, ahmed.mohamed35@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Availability (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03521947, which also lists 4 linked publications.
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 11 May 2018.