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NCT Number: NCT06539702

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

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.

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Key information

Conditions

Blood Platelet Disorder BRAF V600E Blood Platelet Disorders Carcinoma Cytologic Atypia Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Diseases Thyroid Neoplasms Thyroid Nodule

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, 34000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ugur Kesici

PRINCIPAL_INVESTIGATOR

Ugur Kesici, Assoc. Prof

CONTACT

[email protected]

05445474710

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Mean Platelet Volume (MPV) (fL)

    Time frame: 1 week

    Mean Platelet Volume (MPV) (fL) values will be taken and recorded in the preoperative hemogram parameters of all patients.

  2. Neutrophil/lenfosit Ratio (NLR)(103/µL)

    Time frame: 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.

  3. Platelet/Lenfosit Ratio (PLR)(103/µL)

    Time frame: 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.

  4. Lenfosit/Monosit Ratio (LMR)(103/µL)

    Time frame: 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.

Secondary outcomes

  1. BRAF molecular test

    Time frame: 1 week

    Pathological molecular test (25 patients)

Study contacts

Contact information is provided by the study sponsor or research team.

Ugur 1 Kesici, Assoc. Prof.

CONTACT

[email protected]

00905445474710 ext. 50124

Ugur 1 Kesici, Assoc. Prof.

CONTACT

[email protected]

00905445474710 ext. 50124

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study 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.

Acronym: Bethesda3

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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