NCT05552690

Brief Summary

Test globin gene in participants

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

September 19, 2022

Last Update Submit

February 7, 2023

Conditions

Thalassemia TraitThalassemia; Mixed

Outcome Measures

Primary Outcomes (1)

  • Validate accuracy of TGS to provide globin gene mutation compared with conventional testing

    Percentage of accuracy to give the mutation diagnosis

    6 months after blood test

Secondary Outcomes (1)

  • Additional mutation added by TGS

    6 months after blood test

Study Arms (1)

Thalassemia screening positive

OTHER

In this study only 1 group of participants. No comparative. Only description

Procedure: blood draw

Interventions

blood drawPROCEDURE

10 ml of blood will be draw to genetic analysis (sequencing)

Thalassemia screening positive

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Thalassemia carriers or disease individuals with documented as known globin gene mutation.
  • Thalassemia carriers or disease individuals whose mutation did not retrieve from conventional technique and were assigned as no known mutation

You may not qualify if:

  • incomplete medical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maharaj Nakorn ChiangMai Hospital

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Thalassemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 19, 2022

First Posted

September 23, 2022

Study Start

February 1, 2022

Primary Completion

April 30, 2022

Study Completion

May 31, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)