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Delta Neutrophil Index and Neutrophil Lymphocyte Ratio in Thyroid Malignancy

Primary Purpose

Thyroid Cancer, Thyroid Nodule, Thyroid Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Complete Blood Count
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Cancer focused on measuring Delta neutrophyl index, Immature granulocyte count, Thyroid Cancer, Thyroid Nodule, Neutrophyl to lymphocyte ratio

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Sham Comparator

    Other

    Arm Label

    Thyroid Malignancy

    Benign Thyroidal Goitor

    Control Group

    Arm Description

    Thyroidectomy

    Thyroidectomy

    Selective lichtenstein procedure for inguinal hernia

    Outcomes

    Primary Outcome Measures

    Delta neutrophyl index for thyroid malignancies
    The correlation between DNI and thyroid cancer
    Immature granulocyte count for thyroid malignancies
    The correlation between DNI and thyroid cancer
    Neutrophyl to lymphocyte ratio for thyroid malignancies
    The correlation between DNI and thyroid cancer

    Secondary Outcome Measures

    Full Information

    First Posted
    April 23, 2020
    Last Updated
    June 9, 2020
    Sponsor
    Kahramanmaras Sutcu Imam University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04425512
    Brief Title
    Delta Neutrophil Index and Neutrophil Lymphocyte Ratio in Thyroid Malignancy
    Official Title
    Delta Neutrophil Index and Neutrophil Lymphocyte Ratio in Differentiation of Thyroid Malignancy and Nodular Goiter
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2014 (Actual)
    Primary Completion Date
    November 1, 2019 (Actual)
    Study Completion Date
    November 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kahramanmaras Sutcu Imam University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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 (%).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid Cancer, Thyroid Nodule, Thyroid Diseases, Delta Neutrophyl Index, Immature Granulocyte Count, Neutrophyl to Lymphocyte Ratio
    Keywords
    Delta neutrophyl index, Immature granulocyte count, Thyroid Cancer, Thyroid Nodule, Neutrophyl to lymphocyte ratio

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    333 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Thyroid Malignancy
    Arm Type
    Active Comparator
    Arm Description
    Thyroidectomy
    Arm Title
    Benign Thyroidal Goitor
    Arm Type
    Sham Comparator
    Arm Description
    Thyroidectomy
    Arm Title
    Control Group
    Arm Type
    Other
    Arm Description
    Selective lichtenstein procedure for inguinal hernia
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Complete Blood Count
    Other Intervention Name(s)
    Thyroidectomy
    Intervention Description
    Complete Blood Count samples
    Primary Outcome Measure Information:
    Title
    Delta neutrophyl index for thyroid malignancies
    Description
    The correlation between DNI and thyroid cancer
    Time Frame
    retrospective 5 year
    Title
    Immature granulocyte count for thyroid malignancies
    Description
    The correlation between DNI and thyroid cancer
    Time Frame
    retrospective 5 year
    Title
    Neutrophyl to lymphocyte ratio for thyroid malignancies
    Description
    The correlation between DNI and thyroid cancer
    Time Frame
    retrospective 5 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    Smith PW, Hanks LR, Salomonev LJ, Hanks JB. Sabiston's Text Book of Surgery 20th Edition, The Biological Basis of Modern Surgical Practice. 20th edition, Philedelphia/USA: Elsevier; 2017. Chapter 36 Thyroid. Pp: 881-922
    Results Reference
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    PubMed Identifier
    32041420
    Citation
    Madden LL, Nagatsuka M, Vasi AZ, Madrecha J, Smith LJ. Nerve Injury During Ultrasound-Guided Thyroid Biopsy-A First Reported Complication of Permanent Vocal Fold Paralysis. Ear Nose Throat J. 2021 Sep;100(5_suppl):663S-666S. doi: 10.1177/0145561320902855. Epub 2020 Feb 10.
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    Citation
    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.
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    11229684
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    Balkwill F, Mantovani A. Inflammation and cancer: back to Virchow? Lancet. 2001 Feb 17;357(9255):539-45. doi: 10.1016/S0140-6736(00)04046-0.
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    Coffelt SB, Wellenstein MD, de Visser KE. Neutrophils in cancer: neutral no more. Nat Rev Cancer. 2016 Jul;16(7):431-46. doi: 10.1038/nrc.2016.52. Epub 2016 Jun 10.
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    Kocer D, Karakukcu C, Karaman H, Gokay F, Bayram F. May the neutrophil/lymphocyte ratio be a predictor in the differentiation of different thyroid disorders? Asian Pac J Cancer Prev. 2015;16(9):3875-9. doi: 10.7314/apjcp.2015.16.9.3875.
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