Blood Platelet DisorderBethesda3NCT06539702
Preoperative Hemogram Parameters and BRAF Molecular Test Detected by Bethesda 3 Cytology.
An observational study of Blood Platelet Disorder and BRAF V600E, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Platelet Disorder, BRAF V600E, Thyroid Nodule
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2024to 15 Aug 2024
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients between the ages of 18 -75
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Prof. Dr. Cemil Tascioglu City Hospital
Istanbul, 34000
Ugur Kesici, Assoc. Prof, 05445474710, ugurkesici77@mynet.com
ugurkesici77@mynet.com
About this study
Official 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.
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.
Read the 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.
- Conditions
- Blood Platelet Disorder, BRAF V600E, Thyroid Nodule, Cytologic Atypia
- Keywords
- Thyroid, carcinoma, Bethesda 3, BRAF
- Medical subject headings
- Blood Platelet Disorders, Thyroid Nodule, Thyroid Diseases, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Platelet Volume (MPV) (fL)
Mean Platelet Volume (MPV) (fL) values will be taken and recorded in the preoperative hemogram parameters of all patients.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week
Secondary outcomes (1)
BRAF molecular test
Pathological molecular test (25 patients)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start20 Jul 2024
- Primary completion6 Aug 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood Platelet DisorderStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ugur Kesici, Assoc.Prof., Principal investigator, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539702
- Sponsor's protocol ID
- E-48670771-514.99-237222286
- Acronym
- Bethesda3
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35006341Acar 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.
PubMed 33908335
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06539702
- Acronym / sponsor ID
- Bethesda3 / E-48670771-514.99-237222286
- Conditions
- Blood Platelet Disorder, BRAF V600E, Thyroid Nodule, Cytologic Atypia
- Keywords
- Thyroid, carcinoma, Bethesda 3, BRAF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 6 Aug 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18 -75
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
1 secondary outcome
BRAF molecular test
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Results publication: PubMed 35006341Bostan 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.
- Results publication: PubMed 33908335Acar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ugur Kesici, Assoc.Prof. principal investigator
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Platelet Disorder and BRAF V600E, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ugur 1 Kesici, Assoc. Prof. (00905445474710 ext. 50124, ugur.kesici@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Platelet Volume (MPV) (fL) (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06539702, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.