NCT07652450

Brief Summary

This study aim to assess for the incidence of thyroid cancer in patients with autoimmune thyroiditis (Inflammatory thyroid Lesions)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 6, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

Incidental Thyroid CancerAutoimmune ThyroiditisHashimoto ThyroiditisDifferentiated Thyroid CancerPapillary Thyroid Carcinoma

Outcome Measures

Primary Outcomes (1)

  • • Incidence of incidental differentiated thyroid cancer with autoimmune thyroiditis

    Title: Incidence of incidental differentiated thyroid cancer Unit of measure: % of patients (proportion) Metric/method: Histopathological examination of surgical specimen

    At time of surgery (postoperative histopathology)

Secondary Outcomes (8)

  • Incidence of incidental differentiated thyroid cancer by autoimmune thyroiditis subtype

    At time of surgery

  • Outcome 3A: Age comparison

    At time of surgery

  • Outcome 3B: Sex distribution

    Preoperative (within 30 days before surgery)

  • Secondary Outcome 4 - Tumor characteristics Outcome 4A: Tumor size

    At time of surgery

  • Outcome 4B: Microcarcinoma proportion

    At time of surgery

  • +3 more secondary outcomes

Study Arms (1)

Inflammatory thyroid lesions

OTHER

The presence of thyroiditis was determined considering histological diagnosis taken post-surgery, and we considered the correlation between any presence of thyroiditis and all Differentiated thyroid cancer, taken from the histopathological examination after pathologic analysis.

Other: total thyroidectomy

Interventions

Diagnosis of differentiated thyroid cancer: The presence of thyroid cancer was determined based on histopathological examination of the resected specimen

Inflammatory thyroid lesions

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All types of autoimmune thyroiditis, including:
  • Graves' disease
  • Toxic multinodular goiter (TMNG)
  • Toxic nodule (TN)
  • Hashimoto thyroiditis
  • Unspecified toxic nodular goiter
  • Age between 18 and 60 years
  • Underwent thyroid surgical operation (lobectomy or total thyroidectomy)

You may not qualify if:

  • Patients with known differentiated thyroid cancer before surgery
  • Recurrent thyroid disease (previous thyroid surgery)
  • Patients unfit for operation (American Society of Anesthesiologists grade IV or V)
  • Incomplete histopathological data
  • Patients with medullary thyroid carcinoma or anaplastic thyroid cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Minya, Minya Governorate, 61611, Egypt

Location

MeSH Terms

Conditions

Thyroid Cancer, PapillaryHashimoto DiseaseAdenocarcinoma, FollicularThyroiditis, Autoimmune

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesThyroiditisAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of General Surgery, Faculty of Medicine, Minia University, Minia, Egypt.

Study Record Dates

First Submitted

June 6, 2026

First Posted

June 17, 2026

Study Start

February 1, 2025

Primary Completion

February 1, 2026

Study Completion

May 31, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author.

Locations