An observational study in Blood Platelet Disorder, BRAF V600E and Thyroid Nodule, sponsored by Saglik Bilimleri Universitesi. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Saglik Bilimleri Universitesi · Observational
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.
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.
47 studies on the registry are indexed under Blood Platelet Disorders; 9 are open to participants now.
This study's planned enrollment of 120 is close to the median of 120 across 17 observational studies indexed under Blood Platelet Disorders.
Browse Blood Platelet Disorders studies →Saglik Bilimleri Universitesi is the lead sponsor of 453 studies on the registry; 140 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients between the ages of 18 -75
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mean Platelet Volume (MPV), Neutrophil/lymphocyte Ratio (NLR), Platelet/Lymphocyte Ratio (PLR) and Lymphocyte/Monocyte Ratio (LMR) will be recorded in preoperative hemograms. 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. with thyroid nodule identified by Bethesda 3 cytology were examined retrospectively. According to the pathology results, they were divided into 2 groups: benign and malignant. Group B (Benign);Preoperative hemogram parameters, Bethesda 3 cytology, Thyroidectomy, benign pathology. Group M (Malign);Preoperative hemogram parameters, Betheda 3 cytology, Thyroidectomy, malign pathology, BRAF molecular test
Mean Platelet Volume (MPV) (fL)
Mean Platelet Volume (MPV) (fL) values will be taken and recorded in the preoperative hemogram parameters of all patients.
Time frame: 1 week
Neutrophil/lenfosit Ratio (NLR)(103/µL)
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.
Time frame: 1 week
Platelet/Lenfosit Ratio (PLR)(103/µL)
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.
Time frame: 1 week
Lenfosit/Monosit Ratio (LMR)(103/µL)
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.
Time frame: 1 week
BRAF molecular test
Pathological molecular test (25 patients)
Time frame: 1 week
Plan to share: No
Started Jul 2024 (actual). Primary completion is estimated for Aug 2024, 0 months after the start.
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