Assesment of Treatment Outcomes of Aquired Aplastic Anemi... | NCT07131878

Studies
Assesment of Treatment Outcomes of Aquired Aplastic Anemia in Children : A Retrospective and Prospective Cohort

NCT07131878

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Aug 20, 2025Actual

Enrollment

35Estimated

Phase

Not provided

Conditions

Aplastic Anaemia (AA)

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2025Estimated

Primary Completion Date

Sep 15, 2027Estimated

Completion Date

Jan 15, 2028Estimated

First Submitted Date

Aug 13, 2025

First Submission Date that Met QC Criteria

Aug 13, 2025

First Posted Date

Aug 20, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2025

Last Update Posted Date

Aug 20, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to to assess of treatment Outcomes of Aquired Aplastic Anemia in children

Detailed Description

This study will be conducted to investigate the clinical outcomes, and treatment modalities of patients diagnosed with aquired aplastic anaemia at Assiut University children Hospital

The main question it aims to answer is:

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the treatment outcomes of children diagnosed with aplastic anemia.		July 2023-July 2026

Secondary Outcomes

Measure	Description	Time Frame
To assess response rates to various treatment modalities, including: oImmunosuppressive therapy (IST) oHematopoietic stem cell transplantation (HSCT) oSupportive care only		July 2023_July 2026

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 1-18 years diagnosed with acquired aplastic anemia, as confirmed by bone marrow examination and fulfilling diagnostic criteria (e.g., bone marrow cellularity <25% and at least two of the following: absolute neutrophil count <500/μL, platelet count <20,000/μL, absolute reticulocyte count <60,000/μL)123.
The bone marrow biopsy should be compitable with diagnosis
Diagnosed and/or treated at Assiut University Children's Hospital between Agust 2023 and Augst 2026.
Patients with complete medical records, including diagnostic, laboratory, and treatment data

Exclusion Criteria:

Patients with inherited bone marrow failure syndromes (e.g., Fanconi anemia, dyskeratosis congenita) as confirmed by genetic testing or family history21.
Patients with incomplete or missing essential data in their medical records.
Patients diagnosed outside the specified study period or managed primarily at other institutions.
Patinets with neoplastic or granulomatous disease involving the bone marrow, systemic lupus erythematosus, AIDS, hypersplenism or other conditions associated with pancytopenia such as myelodysplastic syndrome,and paroxysmal nocturnal hemoglobinuria.
Patients exposed to antineoplastic chemotherapy or radiotherapy were excluded

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children aged 1-18 years diagnosed with acquired aplastic anemia

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Marwa M Abozaid, master	Contact	+201146679786		marwaabozaid39@gmail.com

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Label	Type	Description	Intervention Names
patient diagnosed with aplastic anemia from July 2023 to sept 2025
patient diagnosed with aplastic anemia from Sept 2025 to July 2026

ID	Term
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000080983	Bone Marrow Failure Disorders