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

NCT06539702 | Recruiting DMC

• 1 other identifier: E-48670771-514.99-237222286
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Thyroid; carcinoma; Bethesda 3; BRAF

Outcome Measures

Primary Outcomes (4)

• Mean Platelet Volume (MPV) (fL)

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

  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.

  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.

  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.

  1 week

Secondary Outcomes (1)

• BRAF molecular test

  1 week

Study Arms (1)

2/Group B (Benign), Group M (Malign)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients between the ages of 18 -75

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 35006341 RESULT

• 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.

  PMID: 33908335 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pathological specimen

MeSH Terms

Conditions

Blood Platelet Disorders; Thyroid Nodule; Thyroid Diseases; Carcinoma

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Ugur Kesici, Assoc.Prof.

  Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ugur 1 Kesici, Assoc. Prof.

CONTACT

00905445474710; ugur.kesici@sbu.edu.tr

Ugur 1 Kesici, Assoc. Prof.

CONTACT

00905445474710; ugurkesici77@mynet.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: August 6, 2024
• Study Start: July 20, 2024
• Primary Completion: August 6, 2024
• Study Completion: August 15, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)