Back to resultsAssociation of TTGA (Tissue Transglutaminase Antibody) and Histopathologic Findings in Thyroidectomy Patients
Primary Purpose
Thyroid Fibrosis
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Measuring of fibrosis in thyroid specimen and measuring of Anti-tTG in serum samples
Sponsored by
About this trial
This is an interventional supportive care trial for Thyroid Fibrosis
Eligibility Criteria
Inclusion Criteria:
- Thyroiditis patients operated for any indication
Exclusion Criteria:
- Patients with known IgA deficiency
Sites / Locations
- SBU Diskapi Yildirim Beyazit Training and Research Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Operated Patients
Arm Description
Measurement of fibrosis degree and Anti-tTG levels
Outcomes
Primary Outcome Measures
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.
Measurement of Anti-tTG levels in serum
Amount of serum Anti-TG in IU/mL
Secondary Outcome Measures
Full Information
NCT ID
NCT04974255
First Posted
May 31, 2021
Last Updated
July 13, 2021
Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04974255
Brief Title
Association of TTGA (Tissue Transglutaminase Antibody) and Histopathologic Findings in Thyroidectomy Patients
Official Title
Does Gluten Sensitivity Play a Role in Development of Thyroiditis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
July 26, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Fibrosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Operated Patients
Arm Type
Experimental
Arm Description
Measurement of fibrosis degree and Anti-tTG levels
Intervention Type
Other
Intervention Name(s)
Measuring of fibrosis in thyroid specimen and measuring of Anti-tTG in serum samples
Intervention Description
Examination of pathology specimen and laboratory measuring
Primary Outcome Measure Information:
Title
Amount of fibrosis in thyroid tissue and measured level of anti-tTG levels in serum
Description
Degree of fibrosis was defined after painting of slides with masson trichrome as absent, mild, moderate semi-quantitatively.
Time Frame
one day after operation
Title
Measurement of Anti-tTG levels in serum
Description
Amount of serum Anti-TG in IU/mL
Time Frame
one day after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Thyroiditis patients operated for any indication
Exclusion Criteria:
Patients with known IgA deficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gorkem Gundogan
Organizational Affiliation
Not Affliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
SBU Diskapi Yildirim Beyazit Training and Research Hospital
City
Ankara
ZIP/Postal Code
06110
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Hospital records
IPD Sharing Time Frame
June 2021 for 1 year
IPD Sharing Access Criteria
No criteria
Learn more about this trial
Association of TTGA (Tissue Transglutaminase Antibody) and Histopathologic Findings in Thyroidectomy Patients
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