Association of TTGA (Tissue Transglutaminase Antibody) and Histopathologic Findings in Thyroidectomy Patients

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Thyroid Fibrosis
• Intervention / Treatment: Other: Measuring of fibrosis in thyroid specimen and measuring of Anti-tTG in serum samples

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 Type: Interventional
• Enrollment (Actual): 198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06110
    • SBU Diskapi Yildirim Beyazit Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Thyroiditis patients operated for any indication

Exclusion Criteria:

• Patients with known IgA deficiency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Operated Patients; Measurement of fibrosis degree and Anti-tTG levels	Other: Measuring of fibrosis in thyroid specimen and measuring of Anti-tTG in serum samples; Examination of pathology specimen and laboratory measuring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one day after operation
Measurement of Anti-tTG levels in serum	Amount of serum Anti-TG in IU/mL	one day after operation

Collaborators and Investigators

• Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
• Investigators: Principal Investigator: Gorkem Gundogan, Not Affliated

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): July 26, 2021
• Study Completion (Anticipated): July 30, 2021

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: 59/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Hospital records
• IPD Sharing Time Frame: June 2021 for 1 year
• IPD Sharing Access Criteria: No criteria
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No