Delta Neutrophil Index and Neutrophil Lymphocyte Ratio in Thyroid Malignancy

June 9, 2020 updated by: Mehmet Buğra Bozan, Kahramanmaras Sutcu Imam University

Delta Neutrophil Index and Neutrophil Lymphocyte Ratio in Differentiation of Thyroid Malignancy and Nodular Goiter

Thyroid surgery is the most common surgical procedure among endocrine surgeries. It is performed in patients with suspected malignancy, patients diagnosed with malignancy, and for toxic nodular goiter [1]. Fine-needle aspiration biopsy (FNAB) is used as a daily technique in preoperative evaluation to differentiate malignant and benign nodules. However, complications including hematoma formation, tumor transplantation along the needle trace, thyroid nodule infarction and vascular proliferation can be seen even in this minimally invasive procedure [2]. Therefore, the differentiation of benign and malignant groups using non-interventional methods before surgery has become important.

Cancer-related inflammation, including papillary thyroid carcinoma, is involved in carcinogenesis and progression of neoplastic disease [3,4]. Neutrophils induced by the tumor can accelerate tumor metastasis [3,5]. Lymphocytes, as the cornerstone of the adaptive immune system, inhibit tumor cell proliferation and migration as well as destroying metastases [3,6]. Previous studies have shown that increased lymphocyte count has a positive effect on better survival in patients with advanced cancer [7]. Furthermore, Kupffer cells, also known as liver macrophages, destroy circulating cancer cells and help the distribution of tumor cells via circulation. Therefore, routine blood tests have been investigated as a predictive or prognostic factor for carcinomas since blood parameters in these tests show whether there is inflammation. Neutrophil count, lymphocyte count, neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), mean platelet volume (MPV), and platelet distribution width (PDW) have been studied in terms of numerous malignancies [3].

Tumor-related inflammation is activated the bone marrow and inflammation induced by malignancies. Inflammatory activity that is poorly controlled or uncontrollable may be responsible for malignant transformation [8]. At this point, NLR has previously been shown to be useful in the differentiation of thyroid malignancies and benign thyroid diseases [9]. Delta neutrophil index (DNI) / increased number of immature granulocytes (IG) represents active bone marrow. Delta neutrophil index, which is manifested by IG formation in inflammatory and infectious events, shows changes in the white blood cell count [10].

This study aimed to evaluate the relation between the automatically calculated DNI/IG count and manually calculated NLR from the preoperative complete blood count (CB) parameters, and thyroid malignancies with a cost-effective non-invasive method before surgery or biopsy as the indicator of the malignant inflammatory response in the differentiation of nodular goiter and thyroid malignancy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

Material-Methods Patients over the age of 18 who underwent thyroid surgery and who were operated on non-malignant benign causes (inguinal hernia) under selective conditions without any thyroid disease between November 2014 and November 2019 in Kahramanmaraş Sütçü İmam University Department of General Surgery were evaluated in this retrospective case-control cohort study. Patients in the thyroid pathology group (Group T) were divided into two subgroups according to their pathologic results: malignant (Group M) and benign thyroid disorders (Group B). Patients operated for inguinal hernia, were selected as control group (Group C).

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Preoperative biopsy results of patients undergoing FNAB in the preoperative period were investigated according to the Bethesda Classification System [11]. Neutrophil - lymphocyte count in the routine complete blood count (CBC) values, which were measured in the preoperative period and the postoperative sixth-month follow-ups, were recorded retrospectively and calculated manually. DNI (IG percentage) and IG counts were recorded from the values measured automatically in the CBC performed in the preoperative period and the postoperative sixth-month. Patient data were obtained from patient epicrisis forms and preoperative laboratory and postoperative pathology results recorded in the computer system.

Statistical Analysis The power analysis of the study was conducted with G-Power 3.0.10 programming system. Estimated power analysis and the sample size with an 0.8 power and effect size 0.1 according to three groups evaluation for 2 repeated measures in need of total 246 samples.

Statistical analysis was performed using IBM Social Package for the Social Sciences (SPSS) version 20 software. In the evaluation of independent groups, Kolmogorov-Smirnov and Shapiro-Wilk tests were used to determine if the distrubiton of variables were normal or not. Student t-test or Mann-Whitney U test was used to evaluate the numerical data between Group C and Group T. ANOVA or Kruskal Wallis test was used to evaluate numerical data for subgroup relations with Group C. Chi-square test or Fischer's exact test was used to evaluate categorical data. The repeated-measures ANOVA was used to evaluate the differences between the preoperative and postoperative periods. The data were evaluated using Posthoc Tukey's B test following the variance analysis. Sensitivity and specificity values and cut-off values were obtained via the receiver operating characteristic (ROC) analysis to evaluate the effectiveness of NLR, IG count, and DNI.

Numerical data were expressed as mean ± standard deviation (minimum-maximum values) or median (minimum-maximum values) according to the normal distribution. Categorical values were expressed as percentages (%).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
333

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

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Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criterias:

  • Operated thyroid malignancy patients (Total thyrodectomy, complementary thyroidectomy)
  • Operated benign thyoridal goitor patients
  • Selectively operated inguinal hernia patients without any concomitant malignancy
  • Selectively operated inguinal hernia patients without any thyroid disorder

Exclusion Criterias:

  • Patients undergoing emergent surgery
  • Patients with concomitant rheumatologic disease undergoing thyroid surgery in selective conditions
  • Patients with concomitant rheumatologic disease undergoing inguinal hernia operation in selective conditions
  • Patients with concomitant thyroid disease undergoing inguinal hernia operation in selective conditions
  • Patients with concomitant any malignancy undergoing inguinal hernia operation in selective conditions
  • Patients whose data were not available or were missing.

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Thyroid Malignancy
Thyroidectomy
Diagnostic test: Complete Blood Count
Complete Blood Count samples
Other Names:
  • Thyroidectomy
Sham Comparator: Benign Thyroidal Goitor
Thyroidectomy
Diagnostic test: Complete Blood Count
Complete Blood Count samples
Other Names:
  • Thyroidectomy
Other: Control Group
Selective lichtenstein procedure for inguinal hernia
Diagnostic test: Complete Blood Count
Complete Blood Count samples
Other Names:
  • Thyroidectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Delta neutrophyl index for thyroid malignancies
Time Frame: retrospective 5 year
The correlation between DNI and thyroid cancer
retrospective 5 year
Immature granulocyte count for thyroid malignancies
Time Frame: retrospective 5 year
The correlation between DNI and thyroid cancer
retrospective 5 year
Neutrophyl to lymphocyte ratio for thyroid malignancies
Time Frame: retrospective 5 year
The correlation between DNI and thyroid cancer
retrospective 5 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kahramanmaras Sutcu Imam University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 355

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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