Red Blood Cell Distributions (RDW, RDW-CW) and Lymphocyte Monocyte Ratios (LMR) for the Malignant Thyroid Nodules

February 28, 2024 updated by: Mehmet Buğra Bozan, Kahramanmaras Sutcu Imam University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

172

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who need thyroid surgery for the malignant and benign ethiologies

Description

Inclusion Criteria:

  • Older than 18 age
  • Thyroidectomy cases

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Benign Thyroid Pathologies
Nodular Goiter Graves Diseases Tocsic Thyroid Nodular Disease
Procedure: Thyroidectomy, Bilaterally Total
Thyroidectomy, Bilaterally Total
Procedure: Thyroidectomy, Unilaterally Total
Thyroidectomy, Unilaterally Total
Procedure: Thyroidectomy, Complementary
Thyroidectomy, Complementary
Procedure: Thyroidectomy, Near Total
Thyroidectomy, Near Total
Thyroid Cancer Cases
Papillary Thyroid Carcinoma Medullary Thyroid Carcinoma Hurthle Cell Carcinoma Anaplastic Thyroid Carcinoma
Procedure: Thyroidectomy, Bilaterally Total
Thyroidectomy, Bilaterally Total
Procedure: Thyroidectomy, Unilaterally Total
Thyroidectomy, Unilaterally Total
Procedure: Thyroidectomy, Complementary
Thyroidectomy, Complementary
Procedure: Thyroidectomy, Near Total
Thyroidectomy, Near Total

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determining benign thyroid nodules
Time Frame: 2016-2021
Determining benign thyroid nodules noninvasively in the preoperative period with complete blood cell parameters
2016-2021
Determining malignant thyroid nodules
Time Frame: 2016-2021
Determining malignant thyroid nodules noninvasively in the preoperative period with complete blood cell parameters
2016-2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kahramanmaras Sutcu Imam University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/11-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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