Thyroid FibrosisNCT04974255
Association of TTGA (Tissue Transglutaminase Antibody) and Histopathologic Findings in Thyroidectomy Patients
A study testing Measuring of fibrosis in thyroid specimen and measuring of Anti-tTG in serum samples in people with Thyroid Fibrosis, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Gluten sensitivity is the most common auto-immune disease associated with auto-immune thyroiditis. This association is through elevated anti-Tissue transglutaminase (Anti-tTG) levels both in Celiac disease and thyroiditis. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Thyroid Fibrosis
- What is being tested?
- Measuring of fibrosis in thyroid specimen and measuring of Anti-tTG in serum samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 30 Jul 2021
- 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 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thyroiditis patients operated for any indication
Who cannot join
- Patients with known IgA deficiency
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06110
About this study
Official title: Does Gluten Sensitivity Play a Role in Development of Thyroiditis
Gluten sensitivity is the most common auto-immune disease associated with auto-immune thyroiditis. This association is through elevated anti-Tissue transglutaminase (Anti-tTG) levels both in Celiac disease and thyroiditis. In our study we tried to find if there is any correlation in between Anti-tTG and degree of fibrosis in thyroid tissue (Post-operative specimen).
Read the detailed description
Most common auto-immune disease associated with Celiac disease is autoimmune thyroiditis. This association in between Celiac disease and aout-immune thyroiditis is related with asymptomatic rise in anti-tTG levels. In our study, we planned to show that if there is any correlation of thyroiditis related fibrosis in thyroid tissue with anti-tTG IgA ( immune-globulin A) and IgG (immune-globulin G).
- Conditions
- Thyroid Fibrosis
- Being tested
- Measuring of fibrosis in thyroid specimen and measuring of Anti-tTG in serum samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring of fibrosis in thyroid specimen and measuring of Anti-tTG in serum samplesOther
Examination of pathology specimen and laboratory measuring
| Study group | Role | What they receive |
|---|---|---|
| Operated Patients | Experimental | Measurement of fibrosis degree and Anti-tTG levels Receives: Other: Measuring of fibrosis in thyroid specimen and measuring of Anti-tTG in serum samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of fibrosis in thyroid tissue and measured level of anti-tTG levels in serum
Degree of fibrosis was defined after painting of slides with masson trichrome as absent, mild, moderate semi-quantitatively.
Measured: one day after operation
Measurement of Anti-tTG levels in serum
Amount of serum Anti-TG in IU/mL
Measured: one day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 May 2019
- Primary completion26 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid FibrosisStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gorkem Gundogan, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- Gorkem Gundogan, Principal investigator, Not Affliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974255
- Sponsor's protocol ID
- 59/02
- Status last verified
- Jul 2021
- First submitted
- 31 May 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Hospital records
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Gluten Sensitivity Play a Role in Development of Thyroiditis
- ClinicalTrials.gov ID
- NCT04974255
- Acronym / sponsor ID
- 59/02
- Conditions
- Thyroid Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 1 May 2019 (actual)
- Primary completion
- 26 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 23 Jul 2021 (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.
Gluten sensitivity is the most common auto-immune disease associated with auto-immune thyroiditis. This association is through elevated anti-Tissue transglutaminase (Anti-tTG) levels both in Celiac disease and thyroiditis. In our study we tried to find if there is any correlation in between Anti-tTG and degree of fibrosis in thyroid tissue (Post-operative specimen).
Detailed description
Most common auto-immune disease associated with Celiac disease is autoimmune thyroiditis. This association in between Celiac disease and aout-immune thyroiditis is related with asymptomatic rise in anti-tTG levels. In our study, we planned to show that if there is any correlation of thyroiditis related fibrosis in thyroid tissue with anti-tTG IgA ( immune-globulin A) and IgG (immune-globulin G).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operated Patients | Experimental | Other: Measuring of fibrosis in thyroid specimen and measuring of Anti-tTG in serum samplesMeasurement of fibrosis degree and Anti-tTG levels |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Thyroiditis patients operated for any indication
Key exclusion criteria (1 listed)
- Patients with known IgA deficiency
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 |
|---|---|---|
| Measuring of fibrosis in thyroid specimen and measuring of Anti-tTG in serum samplesExamination of pathology specimen and laboratory measuring | Other | Operated Patients |
Primary outcome
Amount of fibrosis in thyroid tissue and measured level of anti-tTG levels in serum
Time frame: one day after operation
Degree of fibrosis was defined after painting of slides with masson trichrome as absent, mild, moderate semi-quantitatively.
Measurement of Anti-tTG levels in serum
Time frame: one day after operation
Amount of serum Anti-TG in IU/mL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: Yes. Hospital records
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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.
Gorkem Gundogan principal investigator
Not Affliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measuring of fibrosis in thyroid specimen and measuring of Anti-tTG in serum samples in people with Thyroid Fibrosis, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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 23 Jul 2021. 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 Turkey (Türkiye). 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?
Amount of fibrosis in thyroid tissue and measured level of anti-tTG levels in serum (time frame: one day after operation). The study lists 2 primary outcomes in all. 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 23 Jul 2021.