ClinicalTrials.gg
Not yet recruitingNCT07907432THINCUpdated Nov 2, 2026

Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer

An observational study in Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma and Thyroid Cancer, sponsored by Marmara University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Marmara University · Observational

Updated Nov 2, 2026Primary outcomes revisedNewly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Differentiated Thyroid Cancer (DTC)
  • Papillary Thyroid Carcinoma
  • Thyroid Cancer
  • Thyroid Nodule
  • Nodular Goiter

Keywords

  • Interleukin-17A
  • Treg/Th17 balance
  • Cytokines
  • Thyroidectomy
03

In context

Thyroid Cancer, Papillary

186 studies on the registry are indexed under Thyroid Cancer, Papillary; 51 are open to participants now.

This study's planned enrollment of 90 is below the median of 200 across 66 observational studies indexed under Thyroid Cancer, Papillary.

Browse Thyroid Cancer, Papillary studies →

Lead sponsor

Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutive adults scheduled for elective thyroidectomy for a thyroid nodule or nodular goiter in a single university hospital department of general surgery.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • Final histopathology of differentiated thyroid carcinoma of papillary, follicular or oncocytic type (case group), or of benign nodular goiter (control group)

Exclusion criteria

Exclusion Criteria:

  • Graves disease, toxic multinodular goiter, toxic adenoma, or hyperthyroidism of any cause
  • Active infection
  • Any active non-thyroid
  • Systemic or inflammatory disease other than Hashimoto thyroiditis
  • Use of or systemic therapy
  • Pregnancy
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (1 day before surgery)

Secondary outcomes

  1. 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)

  2. Preoperative serum interleukin-17A to interleukin-10 ratio

    Time frame: Baseline (1 day before surgery)

  3. Preoperative systemic inflammatory indices (neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, systemic immune-inflammation index)

    Time frame: Baseline (1 day before surgery)

  4. 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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared.

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Aug 2027, 9 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 25, 2026
First posted
Oct 30, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Aug 31, 2027
CompletionEst.
Oct 31, 2027
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary outcomes
1 time frame changed
What changed in the outcomes
  • Time framePreoperative serum interleukin-17A concentrationSingle preoperative measurement, on the day of hospital admission → Baseline (1 day before surgery)
Nov 2, 2026
Secondary outcomes
2 edited, 2 time frame changed
What changed in the outcomes
  • EditedPreoperative serum concentrations of other Treg/Th17-related cytokines (interleukin-10, total transforming growth factor beta 1, interferon gamma, tumourtumor necrosis factor alpha, interleukin-6)Time frame: Single preoperative measurement, on the day of hospital admission → Baseline (1 day before surgery)
  • EditedAssociation between preoperative serum cytokine profile and clinicopathological features (tumourtumor size, multifocality, extrathyroidal extension, lymph node metastasis, TNM stage)Time frame: Final histopathology report, within 4 weeks after surgery
  • Time framePreoperative serum interleukin-17A to interleukin-10 ratioSingle preoperative measurement, on the day of hospital admission → Baseline (1 day before surgery)
  • Time framePreoperative systemic inflammatory indices (neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, systemic immune-inflammation index)Single preoperative measurement, on the day of hospital admission → Baseline (1 day before surgery)
Nov 2, 2026
Registered
First appeared on the registry
Oct 30, 2026
Show all 2 updates
  1. Nov 2, 2026
    Primary outcomes 1 time frame changed
    What changed in the outcomes
    • Time framePreoperative serum interleukin-17A concentrationSingle preoperative measurement, on the day of hospital admission → Baseline (1 day before surgery)
    Secondary outcomes 2 edited, 2 time frame changed
    What changed in the outcomes
    • EditedPreoperative serum concentrations of other Treg/Th17-related cytokines (interleukin-10, total transforming growth factor beta 1, interferon gamma, tumourtumor necrosis factor alpha, interleukin-6)Time frame: Single preoperative measurement, on the day of hospital admission → Baseline (1 day before surgery)
    • EditedAssociation between preoperative serum cytokine profile and clinicopathological features (tumourtumor size, multifocality, extrathyroidal extension, lymph node metastasis, TNM stage)Time frame: Final histopathology report, within 4 weeks after surgery
    • Time framePreoperative serum interleukin-17A to interleukin-10 ratioSingle preoperative measurement, on the day of hospital admission → Baseline (1 day before surgery)
    • Time framePreoperative systemic inflammatory indices (neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, systemic immune-inflammation index)Single preoperative measurement, on the day of hospital admission → Baseline (1 day before surgery)
    + 1 other change: description
  2. Oct 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07907432
Lead sponsor
Marmara University
Responsible party
Muhammer Ergenç (Associate Professor of General Surgery, Marmara University) — Principal investigator
First posted
Oct 30, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Aug 31, 2027 (estimated)
Completion
Oct 31, 2027 (estimated)
Last update
Nov 2, 2026

Study contacts

Muhammer Ergenç, MD
Contact
muhammer.ergenc@marmara.edu.tr
+902166254545 ext. 3629
Sevgi Kalkanlı Taş, PhD
Contact
sevgi.kalkanli@sbu.edu.tr
+902167779200
Sevgi Kalkanlı Taş, Professor of Immunology, PhD
study director · Saglik Bilimleri Universitesi
Muhammer Ergenç, MD
principal investigator · Marmara University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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