Preoperative Hemogram Parameters and BRAF Molecular Test Detected by Bethesda 3 Cytology.
- Conditions
- Thyroid NoduleBlood Platelet DisorderCytologic AtypiaBRAF V600E
- Registration Number
- NCT06539702
- Lead Sponsor
- Saglik Bilimleri Universitesi
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Platelet Volume (MPV) (fL) 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) 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) 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) 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 Outcome Measures
Name Time Method BRAF molecular test 1 week Pathological molecular test (25 patients)
Trial Locations
- Locations (1)
Prof. Dr. Cemil Tascioglu City Hospital
🇹🇷Istanbul, Turkey