NCT06283368

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

5 years

First QC Date

February 21, 2024

Last Update Submit

February 28, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Determining benign thyroid nodules

    Determining benign thyroid nodules noninvasively in the preoperative period with complete blood cell parameters

    2016-2021

  • Determining malignant thyroid nodules

    Determining malignant thyroid nodules noninvasively in the preoperative period with complete blood cell parameters

    2016-2021

Study Arms (2)

Benign Thyroid Pathologies

Nodular Goiter Graves Diseases Tocsic Thyroid Nodular Disease

Procedure: Thyroidectomy, Bilaterally TotalProcedure: Thyroidectomy, Unilaterally TotalProcedure: Thyroidectomy, ComplementaryProcedure: Thyroidectomy, Near Total

Thyroid Cancer Cases

Papillary Thyroid Carcinoma Medullary Thyroid Carcinoma Hurthle Cell Carcinoma Anaplastic Thyroid Carcinoma

Procedure: Thyroidectomy, Bilaterally TotalProcedure: Thyroidectomy, Unilaterally TotalProcedure: Thyroidectomy, ComplementaryProcedure: Thyroidectomy, Near Total

Interventions

Thyroidectomy, Bilaterally Total

Benign Thyroid PathologiesThyroid Cancer Cases

Thyroidectomy, Unilaterally Total

Benign Thyroid PathologiesThyroid Cancer Cases

Thyroidectomy, Complementary

Benign Thyroid PathologiesThyroid Cancer Cases

Thyroidectomy, Near Total

Benign Thyroid PathologiesThyroid Cancer Cases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who need thyroid surgery for the malignant and benign ethiologies

You may qualify if:

  • Older than 18 age
  • Thyroidectomy cases

You may not qualify if:

  • Younger than 18 age
  • Patients with other system malignancies
  • Patients with missing data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 33067685BACKGROUND
  • Lee 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.

    PMID: 30588200BACKGROUND
  • Wen 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.

    PMID: 30241494BACKGROUND
  • Yaylaci 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.

    PMID: 27221938BACKGROUND

MeSH Terms

Conditions

Thyroid NoduleThyroid NeoplasmsThyroid Diseases

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Associate

Study Record Dates

First Submitted

February 21, 2024

First Posted

February 28, 2024

Study Start

January 1, 2016

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

March 1, 2024

Record last verified: 2024-02