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Preoperative Hemogram Parameters and BRAF Molecular Test Detected by Bethesda 3 Cytology.

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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06539702
Acronym
Bethesda3
Enrollment
120
Registered
2024-08-06
Start date
2024-07-20
Completion date
2024-08-15
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Platelet Disorder, BRAF V600E, Cytologic Atypia, Thyroid Nodule

Keywords

Thyroid, carcinoma, Bethesda 3, BRAF

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.

Interventions

None listed

Sponsors

Saglik Bilimleri Universitesi
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Platelet Volume (MPV) (fL)1 weekMean Platelet Volume (MPV) (fL) values will be taken and recorded in the preoperative hemogram parameters of all patients.
Neutrophil/lenfosit Ratio (NLR)(103/µL)1 weekNeutrophil/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.
Platelet/Lenfosit Ratio (PLR)(103/µL)1 weekPlatelet/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.
Lenfosit/Monosit Ratio (LMR)(103/µL)1 weekLymphocyte/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.

Secondary

MeasureTime frameDescription
BRAF molecular test1 weekPathological molecular test (25 patients)

Countries

Turkey (Türkiye)

Contacts

Primary ContactUgur 1 Kesici, Assoc. Prof.
ugur.kesici@sbu.edu.tr00905445474710
Backup ContactUgur 1 Kesici, Assoc. Prof.
ugurkesici77@mynet.com00905445474710

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026