Papillary Thyroid CancerThyroid cancerNCT07652450
Incidental Thyroid Cancer in Cases With Inflammatory Thyroid Lesion
A study testing total thyroidectomy in people with Papillary Thyroid Cancer and Hashimoto Disease, run by Minia University at 1 site in Egypt.
Trial summary
This study aim to assess for the incidence of thyroid cancer in patients with autoimmune thyroiditis (Inflammatory thyroid Lesions) Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Papillary Thyroid Cancer, Hashimoto Disease, Hashimoto's Thyroiditis
- What is being tested?
- total thyroidectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 31 May 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidental Thyroid Cancer in Patients With Inflammatory Thyroid Lesions: A Cohort Study From a Tertiary Care Center
This study aim to assess for the incidence of thyroid cancer in patients with autoimmune thyroiditis (Inflammatory thyroid Lesions)
Read the detailed description
The relationship between chronic inflammation and carcinogenesis is well established in multiple organ systems, including the liver, stomach, and colon. In the thyroid, chronic lymphocytic infiltration may create a pro-inflammatory microenvironment that promotes cellular proliferation, DNA damage, and oncogenic transformation. Several studies have suggested an increased risk of thyroid cancer, particularly papillary thyroid carcinoma (PTC), in patients with Hashimoto thyroiditis
- Conditions
- Papillary Thyroid Cancer, Hashimoto Disease, Hashimoto's Thyroiditis, Follicular Thyroid Cancer
- Being tested
- total thyroidectomy
- Keywords
- Incidental Thyroid Cancer, Autoimmune Thyroiditis, Hashimoto Thyroiditis, Differentiated Thyroid Cancer, Papillary Thyroid Carcinoma
- Medical subject headings
- Thyroid Cancer, Papillary, Hashimoto Disease, Adenocarcinoma, Follicular, Thyroiditis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total thyroidectomyOther
Diagnosis of differentiated thyroid cancer: The presence of thyroid cancer was determined based on histopathological examination of the resected specimen
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: total thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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
Measured: At time of surgery (postoperative histopathology)
Secondary outcomes (8)
Incidence of incidental differentiated thyroid cancer by autoimmune thyroiditis subtype
Unit of Measure
Percentage of patients within each subtype (Hashimoto thyroiditis, Graves' disease, toxic nodular goiter)
Metric / Method
Histopathological classification of thyroiditis subtype and cancer diagnosis; comparison using Chi-square test or Fisher's exact test
Measured: At time of surgery
Outcome 3A: Age comparison
Outcome Measure Title Mean age difference between patients with and without incidental differentiated thyroid cancer Unit of Measure Years (mean ± standard deviation) Metric / Method Unpaired Student's t-test or Mann-Whitney U test
Measured: At time of surgery
Outcome 3B: Sex distribution
Field Entry Outcome Measure Title Proportion of patients with positive anti-thyroid peroxidase (anti-TPO) antibodies who have incidental differentiated thyroid cancer Unit of Measure Percentage of patients Metric / Method Serological testing (anti-TPO antibodies measured by immunoassay); Chi-square test or logistic regression for association
Measured: Preoperative (within 30 days before surgery)
Secondary Outcome 4 - Tumor characteristics Outcome 4A: Tumor size
Outcome Measure Title Maximum tumor diameter in incidental differentiated thyroid cancers Unit of Measure Centimeters (mean ± standard deviation and range) Metric / Method Pathological measurement of surgical specimen
Measured: At time of surgery
Outcome 4B: Microcarcinoma proportion
Outcome Measure Title Proportion of incidental thyroid cancers that are microcarcinomas (≤1 cm) Unit of Measure Percentage of patients with incidental cancer Metric / Method Pathological measurement; defined as tumor size ≤1 cm
Measured: At time of surgery
Outcome 4C: Lymph node metastasis
Outcome Measure Title Proportion of patients with incidental differentiated thyroid cancer who have lymph node metastasis Unit of Measure Percentage of patients with incidental cancer Metric / Method Histopathological examination of central neck dissection specimens
Measured: At time of surgery
Outcome 4D: Multifocality
Outcome Measure Title Proportion of patients with incidental differentiated thyroid cancer who have multifocal disease Unit of Measure Percentage of patients with incidental cancer Metric / Method Histopathological examination (two or more distinct tumor foci)
Measured: At time of surgery
Outcome 3E: Extrathyroidal extension
Outcome Measure Title Proportion of patients with incidental differentiated thyroid cancer who have extrathyroidal extension Unit of Measure Percentage of patients with incidental cancer Metric / Method Histopathological examination (minimal or extensive extension)
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Feb 2025
- Primary completion1 Feb 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid CancerStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mohamed Salah, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652450
- Sponsor's protocol ID
- 1462/02/2025
- Acronym
- Thyroid cancer
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidental Thyroid Cancer in Patients With Inflammatory Thyroid Lesions: A Cohort Study From a Tertiary Care Center
- ClinicalTrials.gov ID
- NCT07652450
- Acronym / sponsor ID
- Thyroid cancer / 1462/02/2025
- Conditions
- Papillary Thyroid Cancer, Hashimoto Disease, Hashimoto's Thyroiditis, Follicular Thyroid Cancer
- Keywords
- Incidental Thyroid Cancer, Autoimmune Thyroiditis, Hashimoto Thyroiditis, Differentiated Thyroid Cancer, Papillary Thyroid Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 17 Jun 2026 (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.
This study aim to assess for the incidence of thyroid cancer in patients with autoimmune thyroiditis (Inflammatory thyroid Lesions)
Detailed description
The relationship between chronic inflammation and carcinogenesis is well established in multiple organ systems, including the liver, stomach, and colon. In the thyroid, chronic lymphocytic infiltration may create a pro-inflammatory microenvironment that promotes cellular proliferation, DNA damage, and oncogenic transformation. Several studies have suggested an increased risk of thyroid cancer, particularly papillary thyroid carcinoma (PTC), in patients with Hashimoto thyroiditis
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammatory thyroid lesions | Other | Other: total thyroidectomyThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- All types of autoimmune thyroiditis, including:
- Age between 18 and 60 years
- Underwent thyroid surgical operation (lobectomy or total thyroidectomy)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| total thyroidectomyDiagnosis of differentiated thyroid cancer: The presence of thyroid cancer was determined based on histopathological examination of the resected specimen | Other | Inflammatory thyroid lesions |
Primary outcome
• Incidence of incidental differentiated thyroid cancer with autoimmune thyroiditis
Time frame: At time of surgery (postoperative histopathology)
Title: Incidence of incidental differentiated thyroid cancer Unit of measure: % of patients (proportion) Metric/method: Histopathological examination of surgical specimen
8 secondary outcomes
Incidence of incidental differentiated thyroid cancer by autoimmune thyroiditis subtype
Time frame: At time of surgery
Outcome 3A: Age comparison
Time frame: At time of surgery
Outcome 3B: Sex distribution
Time frame: Preoperative (within 30 days before surgery)
Secondary Outcome 4 - Tumor characteristics Outcome 4A: Tumor size
Time frame: At time of surgery
Outcome 4B: Microcarcinoma proportion
Time frame: At time of surgery
Outcome 4C: Lymph node metastasis
Time frame: At time of surgery
Outcome 4D: Multifocality
Time frame: At time of surgery
Outcome 3E: Extrathyroidal extension
Time frame: At time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total thyroidectomy in people with Papillary Thyroid Cancer and Hashimoto Disease, run by Minia University at 1 site in Egypt.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 11 Aug 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
• Incidence of incidental differentiated thyroid cancer with autoimmune thyroiditis (time frame: At time of surgery (postoperative histopathology)). 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 11 Aug 2026.