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

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04974255

Collaborator

(none)

198

Enrollment

Location

Arm

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Thyroid Fibrosis	Other: Measuring of fibrosis in thyroid specimen and measuring of Anti-tTG in serum samples	N/A

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

Study Type:

Interventional

Actual Enrollment :

198 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Does Gluten Sensitivity Play a Role in Development of Thyroiditis

Actual Study Start Date :

May 1, 2019

Anticipated Primary Completion Date :

Jul 26, 2021

Anticipated Study Completion Date :

Jul 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Amount of fibrosis in thyroid tissue and measured level of anti-tTG levels in serum [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 [one day after operation]
Amount of serum Anti-TG in IU/mL

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 88 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Thyroiditis patients operated for any indication

Exclusion Criteria:

Patients with known IgA deficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SBU Diskapi Yildirim Beyazit Training and Research Hospital	Ankara		Turkey	06110

Sponsors and Collaborators

Diskapi Yildirim Beyazit Education and Research Hospital

Investigators

Principal Investigator: Gorkem Gundogan, Not Affliated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gorkem Gundogan, MD, Senior Resident of General Surgery, Diskapi Yildirim Beyazit Education and Research Hospital

ClinicalTrials.gov Identifier:

NCT04974255

Other Study ID Numbers:

59/02

First Posted:

Jul 23, 2021

Last Update Posted:

Jul 23, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fibrosis

Study Results

No Results Posted as of Jul 23, 2021