Association of Hb F Level With Clinical Severity of Beta... | NCT04917978

Studies
Association of Hb F Level With Clinical Severity of Beta Thalassemia

NCT04917978

Sponsor

Nanfang Hospital, Southern Medical University

Status

Unknown status

Last Update Posted

Jun 11, 2021Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Beta Thalassemia

Interventions

Hematological Phenotype Analysis

Countries

China

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

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2019Actual

Primary Completion Date

Dec 30, 2024Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Jun 3, 2021

First Submission Date that Met QC Criteria

Jun 7, 2021

First Posted Date

Jun 8, 2021Actual

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

Jun 8, 2021

Last Update Posted Date

Jun 11, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Nanfang Hospital, Southern Medical UniversityOTHER

Collaborators

Name	Class
ZhuHai Hospital	OTHER
Shenzhen Children's Hospital	OTHER_GOV
Shenzhen Second People's Hospital	OTHER
Jiangmen Maternity and Child Health Care Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 production of Hb F after birth is an important factor in modifying the clinical severity of beta thalassemia because an increased gamma-globin level will bind the additional a-globin and form Hb F. The objective of this project is to evaluate the association of Hb F level with phenotypic diversity of patients with beta thalassemia.

Detailed Description

Not provided

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

1,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
beta thalassemia patients			Diagnostic Test: Hematological Phenotype Analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hematological Phenotype Analysis	Diagnostic Test	Hematological parameters were determined with an automated hematology analyzer (Sysmex, Japan), and hemoglobin analysis was performed with either high-performance liquid chromatography (Bio- Rad, USA) or capillary electrophoresis (Sebia, France and Helena, USA).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hb F level and severity of anemia	Observational study that analyzed association of Hb F level and anemia severity in patients	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with beta-thalassemia

Exclusion Criteria:

Iron Deficiency Anemia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

β-thalassemia patients from Southern China

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiangmin Xu, Prof. Dr.	Contact	02061648293	86	xixm@smu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southern Medical University	Recruiting	Guangzhou	Guangdong	510515	China

Condition Browse Module

MeSH Terms

ID	Term
D017086	beta-Thalassemia

Ancestor Terms

ID	Term
D013789	Thalassemia
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia

Browse Leaves

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Browse Branches

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