Clinical trial NCT06539702: Preoperative Hemogram Parameters and BRAF Molecular Test Detected by Bethesda 3 Cytology.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Platelet Disorder
BRAF V600E
Thyroid Nodule
Cytologic Atypia
Keywords: Thyroid
carcinoma
Bethesda 3
BRAF
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the ages of 18 -75

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.

Eligibility criteria: Inclusion Criteria:

1. Patients between the ages of 18 -75
2. Patients who were diagnosed with Bethesda III as a result of preoperative FNAC and decided to undergo thyroidectomy

Exclusion Criteria:

1. Patients over 18 years old and under 75 years old
2. Patients with malignancy detected in another focus with preoperative Bethesda III FNAC
3. Detection of malignancy in another focus other than the nodule with Bethesda III cytological result after thyroidectomy
4. Failure to obtain preoperative hemogram results Patients who do not agree to participate in scientific studies for BRAF testing

Primary outcomes:
measure: Mean Platelet Volume (MPV) (fL)
timeFrame: 1 week
measure: Neutrophil/lenfosit Ratio (NLR)(103/µL)
timeFrame: 1 week
measure: Platelet/Lenfosit Ratio (PLR)(103/µL)
timeFrame: 1 week
measure: Lenfosit/Monosit Ratio (LMR)(103/µL)
timeFrame: 1 week
Secondary outcomes:
measure: BRAF molecular test
timeFrame: 1 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Tascioglu City Hospital
Study officials:
affiliation: Prof. Dr. Cemil Tascıoglu City Hospital
name: Ugur Kesici, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bostan H, Sencar ME, Calapkulu M, Hepsen S, Akhanli P, Duger H, Ucan B, Kizilgul M, Ozturk Unsal I, Ozbek M, Cakal E. The predictive value of hematologic parameters in the risk of thyroid malignancy in cases with atypia/follicular lesion of undetermined significance. Eur Arch Otorhinolaryngol. 2022 Aug;279(8):4077-4084. doi: 10.1007/s00405-021-07248-9. Epub 2022 Jan 10.
citation: Acar S, Ercetin C, Sahbaz NA, Tutal F, Yapalak Y, Cosan F, Erbil Y. Hemodynamic Instability during Thyroidectomy in Graves' Disease. J Invest Surg. 2022 Mar;35(3):627-631. doi: 10.1080/08941939.2021.1914785. Epub 2021 Apr 28.