Back to resultsThalassemia Screening by Third Generation Sequencing
Primary Purpose
Thalassemia Trait, Thalassemia; Mixed
Status
Active
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
blood draw
Sponsored by
About this trial
This is an interventional diagnostic trial for Thalassemia Trait
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
-incomplete medical data
Sites / Locations
- Maharaj Nakorn ChiangMai Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Thalassemia screening positive
Arm Description
In this study only 1 group of participants. No comparative. Only description
Outcomes
Primary Outcome Measures
Validate accuracy of TGS to provide globin gene mutation compared with conventional testing
Percentage of accuracy to give the mutation diagnosis
Secondary Outcome Measures
Additional mutation added by TGS
Percentage of mutation are added by sequencing
Full Information
NCT ID
NCT05552690
First Posted
September 19, 2022
Last Updated
February 7, 2023
Sponsor
ChaingMai University
1. Study Identification
Unique Protocol Identification Number
NCT05552690
Brief Title
Thalassemia Screening by Third Generation Sequencing
Official Title
Thalassemia Screening by Third Generation Sequencing (TGS): Pilot Study in Thai Population
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ChaingMai University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Test globin gene in participants
Detailed Description
Recruit individuals who documented as thalassemia carrier or disease and who positive thalassemia screening but unknown mutation.
Blood will be sent for third generation sequencing to review alpha and beta globin gene mutation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thalassemia Trait, Thalassemia; Mixed
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thalassemia screening positive
Arm Type
Other
Arm Description
In this study only 1 group of participants. No comparative. Only description
Intervention Type
Procedure
Intervention Name(s)
blood draw
Intervention Description
10 ml of blood will be draw to genetic analysis (sequencing)
Primary Outcome Measure Information:
Title
Validate accuracy of TGS to provide globin gene mutation compared with conventional testing
Description
Percentage of accuracy to give the mutation diagnosis
Time Frame
6 months after blood test
Secondary Outcome Measure Information:
Title
Additional mutation added by TGS
Description
Percentage of mutation are added by sequencing
Time Frame
6 months after blood test
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
-incomplete medical data
Facility Information:
Facility Name
Maharaj Nakorn ChiangMai Hospital
City
ChiangMai
ZIP/Postal Code
50200
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Thalassemia Screening by Third Generation Sequencing
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