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

NCT ID: NCT06539702

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-20

Study Completion Date

2024-08-15

Brief Summary

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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

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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.

Conditions

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Blood Platelet Disorder BRAF V600E Thyroid Nodule Cytologic Atypia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ugur Kesici, Assoc.Prof.

Role: PRINCIPAL_INVESTIGATOR

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Locations

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Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ugur 1 Kesici, Assoc. Prof.

Role: CONTACT

00905445474710 ext. 50124

Ugur 1 Kesici, Assoc. Prof.

Role: CONTACT

00905445474710 ext. 50124

Facility Contacts

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Ugur Kesici, Assoc. Prof

Role: primary

05445474710

Role: backup

References

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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.

Reference Type RESULT
PMID: 35006341 (View on PubMed)

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.

Reference Type RESULT
PMID: 33908335 (View on PubMed)

Other Identifiers

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E-48670771-514.99-237222286

Identifier Type: -

Identifier Source: org_study_id

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