Recruiting

Bethesda3Predictive Value of Hemogram Parameters and BRAF Test in Thyroid Nodules

What is being collected

Data Collection

Collected at a single point in time - Cross-sectional

No DNA Sample

Who is being recruted

Blood Platelet Disorders+11

+ Carcinoma

+ Endocrine System Diseases

From 18 to 75 Years

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.

Observational

Study Start: July 2024

See protocol details

Summary

Principal SponsorSaglik Bilimleri Universitesi

Study ContactUgur 1 Kesici, Assoc. Prof.More contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 20, 2024

Actual date on which the first participant was enrolled.

The main hypothesis of this study is that preoperative hemogram parameters can be used as biomarkers for malignancy in patients with thyroid nodule Bethesda 3 cytology. The secondary hypothesis is that BRAF molecular testing has a high predictive value in predicting malignancy in patients with thyroid nodule Bethesda 3 cytology. Primary outcome: Preoperative hemogram parameters. Secondary outcome: BRAF positivity. This study aims to reduce unnecessary thyroidectomies, thyroidectomy complications and treatment costs due to Bethesda 3 cytology. The age and gender of all patients to be included in the study will be recorded. Mean Platelet Volume (MPV), Neutrophil/lymphocyte Ratio (NLR), Platelet/Lymphocyte Ratio (PLR) and Lymphocyte/Monocyte Ratio (LMR) will be recorded in preoperative hemograms. Nodule sizes detected by preoperative Bethesda III cytology will be recorded. The sizes of nodules with preoperative AUS cytology after thyroidectomy, determined as a result of pathological examination, will be recorded. Patients with malignant cytology will be divided into papillary thyroid carcinoma (PTC), Follicular Thyroid Carcinoma (FTC), and tumor sizes will be recorded. Among the patients included in the study, BRAF molecular testing will be performed on the preoperative cytology of 25 patients whose thyroidectomy materials were reported to be malignant.

Official TitleTo Reveal the Predictive Value of Preoperative Hemogram Parameters and BRAF Molecular Test in Predicting Malignancy in Cases With Thyroid Nodules Detected by Bethesda 3 Cytology.

NCT06539702

Principal SponsorSaglik Bilimleri Universitesi

Study ContactUgur 1 Kesici, Assoc. Prof.More contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Platelet DisordersCarcinomaEndocrine System DiseasesEndocrine Gland NeoplasmsHead and Neck NeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialThyroid DiseasesThyroid NeoplasmsThyroid Nodule

Criteria

2 inclusion criteria required to participate

Patients between the ages of 18 -75

Patients who were diagnosed with Bethesda III as a result of preoperative FNAC and decided to undergo thyroidectomy

4 exclusion criteria prevent from participating

Patients over 18 years old and under 75 years old

Patients with malignancy detected in another focus with preoperative Bethesda III FNAC

Detection of malignancy in another focus other than the nodule with Bethesda III cytological result after thyroidectomy

Failure to obtain preoperative hemogram results Patients who do not agree to participate in scientific studies for BRAF testing

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, Turkey (Türkiye)Open Prof. Dr. Cemil Tascioglu City Hospital in Google Maps

Recruiting

One Study Center