Clinical and Laboratory Parameters of Myelodysplastic Syn... | NCT06244173

Studies
Clinical and Laboratory Parameters of Myelodysplastic Syndromes at Upper Egypt

NCT06244173

Sponsor

Sohag University

Status

Completed

Last Update Posted

Feb 6, 2024Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Myelodysplastic Syndromes

Interventions

Not provided

Countries

Egypt

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

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Nov 1, 2023Actual

Completion Date

Dec 1, 2023Actual

First Submitted Date

Oct 4, 2023

First Submission Date that Met QC Criteria

Feb 5, 2024

First Posted Date

Feb 6, 2024Actual

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

Feb 5, 2024

Last Update Posted Date

Feb 6, 2024Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of our study is to assess clinical & laboratory parameters of adult Egyptian myelodysplastic syndrome patients in upper Egypt, its correlation with disease-free survival, overall survival (OS) and acute leukemia transformation.

Detailed Description

The aim of this study is to assess clinical & laboratory parameters of adult Egyptian myelodysplastic syndrome patients in upper Egypt, its correlation with disease-free survival, overall survival (OS) and acute leukemia transformation.

Materials and methods:

This study will be conducted in Sohag University Hospital and Assuit University Hospitals on available number of newly diagnosed patients with MDS according to the diagnostic criteria proposed by the WHO in 2016 .

full history taking, clinical assessment and certain laboratory investigations are conducted to every patient enrolled in this study.

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

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival	analysis of collected data	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

De novo MDS according to WHO criteria diagnosis 2016

Exclusion Criteria:

MDS on top of AML

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

cases of Denovo MDS attending to Sohag Univeristy hospital and Assuit University hospitals

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Asmaa abdelbaset, MD	faculty of medicine - Sohag university	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag univeristy hospitals		Sohag		82524	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D009190	Myelodysplastic Syndromes

Ancestor Terms

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided