Thalassemia TraitNCT05552690
Thalassemia Screening by Third Generation Sequencing
A study testing blood draw in people with Thalassemia Trait and Thalassemia; Mixed, run by Chiang Mai University at 1 site in Thailand.
Trial summary
Test globin gene in participants Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thalassemia Trait, Thalassemia; Mixed
- What is being tested?
- blood draw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -incomplete medical data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thalassemia Screening by Third Generation Sequencing (TGS): Pilot Study in Thai Population
Test globin gene in participants
Read the 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.
- Conditions
- Thalassemia Trait, Thalassemia; Mixed
- Being tested
- blood draw
- Medical subject headings
- Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawProcedure or surgery
10 ml of blood will be draw to genetic analysis (sequencing)
| Study group | Role | What they receive |
|---|---|---|
| Thalassemia screening positive | Other | In this study only 1 group of participants. No comparative. Only description Receives: Procedure: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate accuracy of TGS to provide globin gene mutation compared with conventional testing
Percentage of accuracy to give the mutation diagnosis
Measured: 6 months after blood test
Secondary outcomes (1)
Additional mutation added by TGS
Percentage of mutation are added by sequencing
Measured: 6 months after blood test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Feb 2022
- Primary completion30 Apr 2022
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thalassemia TraitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuntharee Traisrisilp, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552690
- Sponsor's protocol ID
- 513/2021
- Status last verified
- Feb 2023
- First submitted
- 19 Sep 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalassemia Screening by Third Generation Sequencing (TGS): Pilot Study in Thai Population
- ClinicalTrials.gov ID
- NCT05552690
- Acronym / sponsor ID
- 513/2021
- Conditions
- Thalassemia Trait, Thalassemia; Mixed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thalassemia screening positive | Other | Procedure: blood drawIn this study only 1 group of participants. No comparative. Only description |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -incomplete medical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood draw10 ml of blood will be draw to genetic analysis (sequencing) | Procedure or surgery | Thalassemia screening positive |
Primary outcome
Validate accuracy of TGS to provide globin gene mutation compared with conventional testing
Time frame: 6 months after blood test
Percentage of accuracy to give the mutation diagnosis
1 secondary outcome
Additional mutation added by TGS
Time frame: 6 months after blood test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood draw in people with Thalassemia Trait and Thalassemia; Mixed, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate accuracy of TGS to provide globin gene mutation compared with conventional testing (time frame: 6 months after blood test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.