Thyroid Neoplasms BenignNCT06283368
Red Blood Cell Distributions (RDW, RDW-CW) and Lymphocyte Monocyte Ratios (LMR) for the Malignant Thyroid Nodules
An observational study of Thyroid Neoplasms Benign and Thyroid Nodule, run by Kahramanmaras Sutcu Imam University.
Trial summary
Thyroid surgery is the most common type of surgery among endocrine surgeries. This surgery is performed for patients with suspected malignancy, patients diagnosed with malignancy, and toxic nodular goiter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Neoplasms Benign, Thyroid Nodule, Thyroid Cancer
- What is being tested?
- Thyroidectomy, Bilaterally Total, Thyroidectomy, Unilaterally Total and Thyroidectomy, Complementary
- Type of treatment
- Surgery or procedure
- How many people
- 172 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who need thyroid surgery for the malignant and benign ethiologies
Who may be able to join
- Older than 18 age
- Thyroidectomy cases
Who cannot join
- Younger than 18 age
- Patients with other system malignancies
- Patients with missing data
About this study
Official title: Red Blood Cell Distributions (RDW, RDW-CW) and Lymphocyte Monocyte Ratios (LMR) for the Detection of Malignant Thyroid Nodules in the Preoperative Period.
Thyroid surgery is the most common type of surgery among endocrine surgeries. This surgery is performed for patients with suspected malignancy, patients diagnosed with malignancy, and toxic nodular goiter. In addition to vocal cord injury, which is the most important complication of thyroid surgery, hypocalcemia due to hypoparathyroidism and surgical wound complications (such as hematoma, and fistula) can also be observed, and malignancy surgery increases the risk of recurrent laryngeal nerve injury. Therefore, it is important to differentiate these groups using non-invasive methods before surgery.
Tumor-related inflammation is activated as a result of bone marrow and inflammation induced by malignancies. Insufficiently controlled or uncontrolled inflammatory activity may be responsible for malignant transformation. Lymphocyte monocyte ratio and red blood cell distribution are parameters (RDW, RDW-CW) previously studied in terms of cancers.
Our aim in this study is to reveal the RDW, RDW-CW, and LMR calculated from complete blood count parameters in the preoperative period, as an indicator of malignant inflammatory response, in a non-invasive and inexpensive way before surgery or biopsy is performed to distinguish nodular goiter and thyroid malignancy.
Read the detailed description
Thyroid surgery patients older than 18 who were operated on at the Department of General Surgery of Kahramanmaras Sutcu Imam University between January 2016 and January 2021 for nodular goiter and thyroid malignancy (surgical procedures include bilateral total thyroidectomy, unilateral total thyroidectomy, bilateral subtotal thyroidectomy, unilateral subtotal thyroidectomy, bilateral near total, completion thyroidectomy for recurrent cases). Patients will be evaluated as malignant patients and patients with benign goiter diseases according to the pathology results. Lymphocyte-monocyte ratios will be calculated manually by recording lymphocyte numbers, monocyte numbers, and red blood cell distribution volumes (RDW and RDW-CW) in the routine complete blood count values of the patients in the preoperative period. Patient data will be accessed from the preoperative laboratory and postoperative pathology results recorded in patient epicrisis forms and the computer system.
- Being tested
- Thyroidectomy, Bilaterally Total, Thyroidectomy, Unilaterally Total, Thyroidectomy, Complementary, Thyroidectomy, Near Total
- Medical subject headings
- Thyroid Nodule, Thyroid Neoplasms, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroidectomy, Bilaterally TotalProcedure or surgery
Thyroidectomy, Bilaterally Total
Thyroidectomy, Unilaterally TotalProcedure or surgery
Thyroidectomy, Unilaterally Total
Thyroidectomy, ComplementaryProcedure or surgery
Thyroidectomy, Complementary
Thyroidectomy, Near TotalProcedure or surgery
Thyroidectomy, Near Total
| Study group | Role | What they receive |
|---|---|---|
| Benign Thyroid Pathologies | Nodular Goiter Graves Diseases Tocsic Thyroid Nodular Disease Receives: Procedure: Thyroidectomy, Bilaterally Total; Procedure: Thyroidectomy, Unilaterally Total; Procedure: Thyroidectomy, Complementary; Procedure: Thyroidectomy, Near Total | |
| Thyroid Cancer Cases | Papillary Thyroid Carcinoma Medullary Thyroid Carcinoma Hurthle Cell Carcinoma Anaplastic Thyroid Carcinoma Receives: Procedure: Thyroidectomy, Bilaterally Total; Procedure: Thyroidectomy, Unilaterally Total; Procedure: Thyroidectomy, Complementary; Procedure: Thyroidectomy, Near Total |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining benign thyroid nodules
Determining benign thyroid nodules noninvasively in the preoperative period with complete blood cell parameters
Measured: 2016-2021
Determining malignant thyroid nodules
Determining malignant thyroid nodules noninvasively in the preoperative period with complete blood cell parameters
Measured: 2016-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study startJan 2016
- Primary completionJan 2021
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thyroid Neoplasms BenignStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Buğra Bozan, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283368
- Sponsor's protocol ID
- 2021/11-06
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bozan MB, Yazar FM, Kale IT, Yuzbasioglu MF, Boran OF, Azak Bozan A. Delta Neutrophil Index and Neutrophil-to-Lymphocyte Ratio in the Differentiation of Thyroid Malignancy and Nodular Goiter. World J Surg. 2021 Feb;45(2):507-514. doi: 10.1007/s00268-020-05822-6. Epub 2020 Oct 16.
PubMed 33067685Lee F, Yang PS, Chien MN, Lee JJ, Leung CH, Cheng SP. An Increased Neutrophil-to-Lymphocyte Ratio Predicts Incomplete Response to Therapy in Differentiated Thyroid Cancer. Int J Med Sci. 2018 Nov 23;15(14):1757-1763. doi: 10.7150/ijms.28498. eCollection 2018.
PubMed 30588200Wen W, Wu P, Li J, Wang H, Sun J, Chen H. Predictive values of the selected inflammatory index in elderly patients with papillary thyroid cancer. J Transl Med. 2018 Sep 21;16(1):261. doi: 10.1186/s12967-018-1636-y.
PubMed 30241494Yaylaci S, Tosun O, Sahin O, Genc AB, Aydin E, Demiral G, Karahalil F, Olt S, Ergenc H, Varim C. Lack of Variation in Inflammatory Hematological Parameters between Benign Nodular Goiter and Papillary Thyroid Cancer. Asian Pac J Cancer Prev. 2016;17(4):2321-3. doi: 10.7314/apjcp.2016.17.4.2321.
PubMed 27221938
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Blood Cell Distributions (RDW, RDW-CW) and Lymphocyte Monocyte Ratios (LMR) for the Detection of Malignant Thyroid Nodules in the Preoperative Period.
- ClinicalTrials.gov ID
- NCT06283368
- Acronym / sponsor ID
- 2021/11-06
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 28 Feb 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.
Thyroid surgery is the most common type of surgery among endocrine surgeries. This surgery is performed for patients with suspected malignancy, patients diagnosed with malignancy, and toxic nodular goiter. In addition to vocal cord injury, which is the most important complication of thyroid surgery, hypocalcemia due to hypoparathyroidism and surgical wound complications (such as hematoma, and fistula) can also be observed, and malignancy surgery increases the risk of recurrent laryngeal nerve injury. Therefore, it is important to differentiate these groups using non-invasive methods before surgery.
Tumor-related inflammation is activated as a result of bone marrow and inflammation induced by malignancies. Insufficiently controlled or uncontrolled inflammatory activity may be responsible for malignant transformation. Lymphocyte monocyte ratio and red blood cell distribution are parameters (RDW, RDW-CW) previously studied in terms of cancers.
Our aim in this study is to reveal the RDW, RDW-CW, and LMR calculated from complete blood count parameters in the preoperative period, as an indicator of malignant inflammatory response, in a non-invasive and inexpensive way before surgery or biopsy is performed to distinguish nodular goiter and thyroid malignancy.
Detailed description
Thyroid surgery patients older than 18 who were operated on at the Department of General Surgery of Kahramanmaras Sutcu Imam University between January 2016 and January 2021 for nodular goiter and thyroid malignancy (surgical procedures include bilateral total thyroidectomy, unilateral total thyroidectomy, bilateral subtotal thyroidectomy, unilateral subtotal thyroidectomy, bilateral near total, completion thyroidectomy for recurrent cases). Patients will be evaluated as malignant patients and patients with benign goiter diseases according to the pathology results. Lymphocyte-monocyte ratios will be calculated manually by recording lymphocyte numbers, monocyte numbers, and red blood cell distribution volumes (RDW and RDW-CW) in the routine complete blood count values of the patients in the preoperative period. Patient data will be accessed from the preoperative laboratory and postoperative pathology results recorded in patient epicrisis forms and the computer system.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benign Thyroid Pathologies | – | Procedure: Thyroidectomy, Bilaterally Total, Procedure: Thyroidectomy, Unilaterally Total, Procedure: Thyroidectomy, Complementary, Procedure: Thyroidectomy, Near TotalNodular Goiter Graves Diseases Tocsic Thyroid Nodular Disease |
| Thyroid Cancer Cases | – | Procedure: Thyroidectomy, Bilaterally Total, Procedure: Thyroidectomy, Unilaterally Total, Procedure: Thyroidectomy, Complementary, Procedure: Thyroidectomy, Near TotalPapillary Thyroid Carcinoma Medullary Thyroid Carcinoma Hurthle Cell Carcinoma Anaplastic Thyroid Carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who need thyroid surgery for the malignant and benign ethiologies
Key inclusion criteria (2 listed)
- Older than 18 age
- Thyroidectomy cases
Key exclusion criteria (3 listed)
- Younger than 18 age
- Patients with other system malignancies
- Patients with missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroidectomy, Bilaterally TotalThyroidectomy, Bilaterally Total | Procedure or surgery | Benign Thyroid Pathologies, Thyroid Cancer Cases |
| Thyroidectomy, Unilaterally TotalThyroidectomy, Unilaterally Total | Procedure or surgery | Benign Thyroid Pathologies, Thyroid Cancer Cases |
| Thyroidectomy, ComplementaryThyroidectomy, Complementary | Procedure or surgery | Benign Thyroid Pathologies, Thyroid Cancer Cases |
| Thyroidectomy, Near TotalThyroidectomy, Near Total | Procedure or surgery | Benign Thyroid Pathologies, Thyroid Cancer Cases |
Primary outcome
Determining benign thyroid nodules
Time frame: 2016-2021
Determining benign thyroid nodules noninvasively in the preoperative period with complete blood cell parameters
Determining malignant thyroid nodules
Time frame: 2016-2021
Determining malignant thyroid nodules noninvasively in the preoperative period with complete blood cell parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 33067685Bozan MB, Yazar FM, Kale IT, Yuzbasioglu MF, Boran OF, Azak Bozan A. Delta Neutrophil Index and Neutrophil-to-Lymphocyte Ratio in the Differentiation of Thyroid Malignancy and Nodular Goiter. World J Surg. 2021 Feb;45(2):507-514. doi: 10.1007/s00268-020-05822-6. Epub 2020 Oct 16.
- Background: PubMed 30588200Lee F, Yang PS, Chien MN, Lee JJ, Leung CH, Cheng SP. An Increased Neutrophil-to-Lymphocyte Ratio Predicts Incomplete Response to Therapy in Differentiated Thyroid Cancer. Int J Med Sci. 2018 Nov 23;15(14):1757-1763. doi: 10.7150/ijms.28498. eCollection 2018.
- Background: PubMed 30241494Wen W, Wu P, Li J, Wang H, Sun J, Chen H. Predictive values of the selected inflammatory index in elderly patients with papillary thyroid cancer. J Transl Med. 2018 Sep 21;16(1):261. doi: 10.1186/s12967-018-1636-y.
- Background: PubMed 27221938Yaylaci S, Tosun O, Sahin O, Genc AB, Aydin E, Demiral G, Karahalil F, Olt S, Ergenc H, Varim C. Lack of Variation in Inflammatory Hematological Parameters between Benign Nodular Goiter and Papillary Thyroid Cancer. Asian Pac J Cancer Prev. 2016;17(4):2321-3. doi: 10.7314/apjcp.2016.17.4.2321.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Neoplasms Benign and Thyroid Nodule, run by Kahramanmaras Sutcu Imam University.
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 3 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: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining benign thyroid nodules (time frame: 2016-2021). The study lists 2 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 NCT06283368, which also lists 4 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 1 Mar 2024.