Differentiated Thyroid Cancer (DTC)THINCNCT07907432
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
An observational study of Differentiated Thyroid Cancer (DTC) and Papillary Thyroid Carcinoma, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study measures circulating immune-signaling molecules before thyroid surgery to determine whether they differ between patients whose thyroid nodule proves to be a differentiated thyroid carcinoma and patients whose nodule proves to be benign. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma, Thyroid Cancer
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adults scheduled for elective thyroidectomy for a thyroid nodule or nodular goiter in a single university hospital department of general surgery.
Who may be able to join
- Age 18 to 75 years
- Scheduled for elective thyroidectomy for a thyroid nodule or nodular goiter
- Euthyroid, defined as thyroid stimulating hormone and free thyroxine within the laboratory reference range on the day of blood sampling
- Written informed consent
- Final histopathology of differentiated thyroid carcinoma of papillary, follicular or oncocytic type (case group), or of benign nodular goiter (control group)
Who cannot join
- Graves disease, toxic multinodular goiter, toxic adenoma, or hyperthyroidism of any cause
- Active infection
- Any active non-thyroid malignancy
- Systemic autoimmune or inflammatory disease other than Hashimoto thyroiditis
- Use of immunosuppressive or systemic corticosteroid therapy
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Marmara University School of Medicine Hospital, Department of General Surgery
Istanbul, 34854
Muhammer Ergenç, MD, +902166254545 ext. 3629, muhammer.ergenc@marmara.edu.tr
About this study
Official title: Treg/Th17-Related Cytokine Profile and Systemic Inflammatory Indices in Differentiated Thyroid Cancer: Relationship With Clinicopathological Features
This study measures circulating immune-signaling molecules before thyroid surgery to determine whether they differ between patients whose thyroid nodule proves to be a differentiated thyroid carcinoma and patients whose nodule proves to be benign.
Adults scheduled for elective thyroidectomy for a thyroid nodule or nodular goiter are enrolled consecutively before surgery, while the nature of the nodule is still unknown. One additional blood tube is obtained during the routine preoperative blood sampling that is performed for every patient on the day of hospital admission, one day before surgery. No separate venipuncture, no additional test, no additional visit and no change to diagnosis, treatment or follow-up is involved.
Serum interleukin-17A, measured before surgery, is the primary outcome measure. Additional Treg/Th17-related cytokines, the interleukin-17A to interleukin-10 ratio, and systemic inflammatory indices calculated from the same blood draw are secondary outcome measures. Participants are assigned to the differentiated thyroid cancer group or the benign nodular goiter group after surgery, on the basis of the final histopathology report.
Read the detailed description
Differentiated thyroid carcinoma is the most common endocrine malignancy, and regulatory T cell and T helper 17 related cytokines are implicated in its immune escape and progression. Recent reports suggest that preoperative serum interleukin-17A discriminates malignant from benign thyroid disease, but none defined a primary outcome in advance or related cytokine levels to clinicopathological aggressiveness. This study addresses those gaps.
Design. Prospective, single-center, observational study in a university hospital department of general surgery. Patients scheduled for elective thyroidectomy for a thyroid nodule or nodular goiter who meet the eligibility criteria are invited consecutively. Groups are defined after surgery from the final histopathology report: differentiated thyroid carcinoma of papillary, follicular or oncocytic type (cases) and benign nodular goiter (controls). No intervention, randomization or treatment modification is involved, and clinical management is unchanged by participation.
Sample collection. Patients are admitted one day before surgery, and preoperative tests are repeated on the day of admission for every patient as standard departmental practice. The study sample is a single additional serum tube drawn during that routine sampling, without a separate venipuncture, after an overnight fast and before any premedication, anesthetic or prophylactic antibiotic. Serum is stored frozen until recruitment is complete and all samples are assayed in a single batch.
Measurements. Cytokines are measured by ELISA on coded samples. Systemic inflammatory indices are calculated only from the complete blood count obtained in the same blood draw, so that cytokine levels and inflammatory indices are contemporaneous.
- Conditions
- Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma, Thyroid Cancer, Thyroid Nodule, Nodular Goiter
- Keywords
- Interleukin-17A, Treg/Th17 balance, Cytokines, Thyroidectomy
- Medical subject headings
- Thyroid Cancer, Papillary, Thyroid Neoplasms, Thyroid Nodule, Goiter, Nodular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Differentiated thyroid carcinoma | Participants undergoing elective thyroidectomy whose final histopathology shows differentiated thyroid carcinoma of papillary, follicular or oncocytic type. | |
| Benign nodular goiter | Participants undergoing elective thyroidectomy for a euthyroid thyroid nodule or nodular goiter whose final histopathology is benign. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative serum interleukin-17A concentration
Serum interleukin-17A concentration measured by ELISA in a blood sample obtained before surgery, compared between participants with differentiated thyroid carcinoma and participants with benign nodular goiter on final histopathology.
Measured: Baseline (1 day before surgery)
Secondary outcomes (4)
Preoperative serum concentrations of other Treg/Th17-related cytokines (interleukin-10, total transforming growth factor beta 1, interferon gamma, tumor necrosis factor alpha, interleukin-6)
Measured: Baseline (1 day before surgery)
Preoperative serum interleukin-17A to interleukin-10 ratio
Measured: Baseline (1 day before surgery)
Preoperative systemic inflammatory indices (neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, systemic immune-inflammation index)
Measured: Baseline (1 day before surgery)
Association between preoperative serum cytokine profile and clinicopathological features (tumor size, multifocality, extrathyroidal extension, lymph node metastasis, TNM stage)
Measured: Final histopathology report, within 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Differentiated Thyroid Cancer (DTC)Studies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Muhammer Ergenç, Marmara University
- Investigators
- Sevgi Kalkanlı Taş, Professor of Immunology, PhD, Study director, Saglik Bilimleri UniversitesiMuhammer Ergenç, MD, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907432
- Sponsor's protocol ID
- BES-2026-02
- Acronym
- THINC
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treg/Th17-Related Cytokine Profile and Systemic Inflammatory Indices in Differentiated Thyroid Cancer: Relationship With Clinicopathological Features
- ClinicalTrials.gov ID
- NCT07907432
- Acronym / sponsor ID
- THINC / BES-2026-02
- Conditions
- Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma, Thyroid Cancer, Thyroid Nodule, Nodular Goiter
- Keywords
- Interleukin-17A, Treg/Th17 balance, Cytokines, Thyroidectomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 30 Oct 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 measures circulating immune-signaling molecules before thyroid surgery to determine whether they differ between patients whose thyroid nodule proves to be a differentiated thyroid carcinoma and patients whose nodule proves to be benign.
Adults scheduled for elective thyroidectomy for a thyroid nodule or nodular goiter are enrolled consecutively before surgery, while the nature of the nodule is still unknown. One additional blood tube is obtained during the routine preoperative blood sampling that is performed for every patient on the day of hospital admission, one day before surgery. No separate venipuncture, no additional test, no additional visit and no change to diagnosis, treatment or follow-up is involved.
Serum interleukin-17A, measured before surgery, is the primary outcome measure. Additional Treg/Th17-related cytokines, the interleukin-17A to interleukin-10 ratio, and systemic inflammatory indices calculated from the same blood draw are secondary outcome measures. Participants are assigned to the differentiated thyroid cancer group or the benign nodular goiter group after surgery, on the basis of the final histopathology report.
Detailed description
Differentiated thyroid carcinoma is the most common endocrine malignancy, and regulatory T cell and T helper 17 related cytokines are implicated in its immune escape and progression. Recent reports suggest that preoperative serum interleukin-17A discriminates malignant from benign thyroid disease, but none defined a primary outcome in advance or related cytokine levels to clinicopathological aggressiveness. This study addresses those gaps.
Design. Prospective, single-center, observational study in a university hospital department of general surgery. Patients scheduled for elective thyroidectomy for a thyroid nodule or nodular goiter who meet the eligibility criteria are invited consecutively. Groups are defined after surgery from the final histopathology report: differentiated thyroid carcinoma of papillary, follicular or oncocytic type (cases) and benign nodular goiter (controls). No intervention, randomization or treatment modification is involved, and clinical management is unchanged by participation.
Sample collection. Patients are admitted one day before surgery, and preoperative tests are repeated on the day of admission for every patient as standard departmental practice. The study sample is a single additional serum tube drawn during that routine sampling, without a separate venipuncture, after an overnight fast and before any premedication, anesthetic or prophylactic antibiotic. Serum is stored frozen until recruitment is complete and all samples are assayed in a single batch.
Measurements. Cytokines are measured by ELISA on coded samples. Systemic inflammatory indices are calculated only from the complete blood count obtained in the same blood draw, so that cytokine levels and inflammatory indices are contemporaneous.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Differentiated thyroid carcinoma | – | –Participants undergoing elective thyroidectomy whose final histopathology shows differentiated thyroid carcinoma of papillary, follicular or oncocytic type. |
| Benign nodular goiter | – | –Participants undergoing elective thyroidectomy for a euthyroid thyroid nodule or nodular goiter whose final histopathology is benign. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adults scheduled for elective thyroidectomy for a thyroid nodule or nodular goiter in a single university hospital department of general surgery.
Key inclusion criteria (5 listed)
- Age 18 to 75 years
- Scheduled for elective thyroidectomy for a thyroid nodule or nodular goiter
- Euthyroid, defined as thyroid stimulating hormone and free thyroxine within the laboratory reference range on the day of blood sampling
- Written informed consent
- Final histopathology of differentiated thyroid carcinoma of papillary, follicular or oncocytic type (case group), or of benign nodular goiter (control group)
Key exclusion criteria (6 listed)
- Graves disease, toxic multinodular goiter, toxic adenoma, or hyperthyroidism of any cause
- Active infection
- Any active non-thyroid malignancy
- Systemic autoimmune or inflammatory disease other than Hashimoto thyroiditis
- Use of immunosuppressive or systemic corticosteroid therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preoperative serum interleukin-17A concentration
Time frame: Baseline (1 day before surgery)
Serum interleukin-17A concentration measured by ELISA in a blood sample obtained before surgery, compared between participants with differentiated thyroid carcinoma and participants with benign nodular goiter on final histopathology.
4 secondary outcomes
Preoperative serum concentrations of other Treg/Th17-related cytokines (interleukin-10, total transforming growth factor beta 1, interferon gamma, tumor necrosis factor alpha, interleukin-6)
Time frame: Baseline (1 day before surgery)
Preoperative serum interleukin-17A to interleukin-10 ratio
Time frame: Baseline (1 day before surgery)
Preoperative systemic inflammatory indices (neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, systemic immune-inflammation index)
Time frame: Baseline (1 day before surgery)
Association between preoperative serum cytokine profile and clinicopathological features (tumor size, multifocality, extrathyroidal extension, lymph node metastasis, TNM stage)
Time frame: Final histopathology report, within 4 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
Related trials for Differentiated Thyroid Cancer (DTC)
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Cancer, Renal Cell Carcinoma (RCC)
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A Real-World Study of Second-line Therapies Among Radioiodine-refractory Differentiated Thyroid Cancer (RAI-R DTC) Patients
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Thyroid Health Outcomes Registry for Surgery
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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.
Sevgi Kalkanlı Taş, Professor of Immunology, PhD study director
Saglik Bilimleri Universitesi
Muhammer Ergenç, MD principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Differentiated Thyroid Cancer (DTC) and Papillary Thyroid Carcinoma, run by Marmara University at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 2 Nov 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammer Ergenç, MD (+902166254545 ext. 3629, muhammer.ergenc@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative serum interleukin-17A concentration (time frame: Baseline (1 day before surgery)). 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 2 Nov 2026.