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Trial Title:
Preoperative Hemogram Parameters and BRAF Molecular Test Detected by Bethesda 3 Cytology.
NCT ID:
NCT06539702
Condition:
Blood Platelet Disorder
BRAF V600E
Thyroid Nodule
Cytologic Atypia
Conditions: Official terms:
Thyroid Nodule
Blood Platelet Disorders
Thyroid Diseases
Conditions: Keywords:
Thyroid
carcinoma
Bethesda 3
BRAF
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
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.
Criteria for eligibility:
Study pop:
Patients between the ages of 18 -75
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Prof. Dr. Cemil Tascioglu City Hospital
Address:
City:
Istanbul
Zip:
34000
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Ugur Kesici, Assoc. Prof
Phone:
05445474710
Email:
ugurkesici77@mynet.com
Contact backup:
Phone ext:
Kesici
Email:
ugurkesici77@mynet.com
Investigator:
Last name:
Ugur Kesici
Email:
Principal Investigator
Start date:
July 20, 2024
Completion date:
August 15, 2024
Lead sponsor:
Agency:
Saglik Bilimleri Universitesi
Agency class:
Other
Source:
Saglik Bilimleri Universitesi
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06539702
