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Clinical Trials/NCT06539702
NCT06539702
Recruiting
Not Applicable

To 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.

Saglik Bilimleri Universitesi1 site in 1 country120 target enrollmentJuly 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Blood Platelet Disorder
Sponsor
Saglik Bilimleri Universitesi
Enrollment
120
Locations
1
Primary Endpoint
Mean Platelet Volume (MPV) (fL)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 20, 2024
End Date
August 15, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Mean Platelet Volume (MPV) (fL)

Time Frame: 1 week

Mean Platelet Volume (MPV) (fL) values will be taken and recorded in the preoperative hemogram parameters of all patients.

Lenfosit/Monosit Ratio (LMR)(103/µL)

Time Frame: 1 week

Lymphocyte/Monocyte Ratio (LMR) will be calculated by taking the Lymphocyte (103/µL) and Monocyte (103/µL) values in the preoperative hemogram parameters of all patients.

Platelet/Lenfosit Ratio (PLR)(103/µL)

Time Frame: 1 week

Platelet/lymphocyte ratio (PLR) will be calculated by taking the Platelet (103/µL) and Lymphocyte (103/µL) values in the preoperative hemogram parameters of all patients.

Neutrophil/lenfosit Ratio (NLR)(103/µL)

Time Frame: 1 week

Neutrophil/lymphocyte ratio (NLR) will be calculated by taking the Neutrophil (103/µL) and Lymphocyte (103/µL) values in the preoperative hemogram parameters of all patients.

Secondary Outcomes

  • BRAF molecular test(1 week)

Study Sites (1)

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