Delta Neutrophil Index and Neutrophil Lymphocyte Ratio in Thyroid Malignancy

NCT04425512 | Completed

• 1 other identifier: 355
• Study Type: interventional
• Target: 333
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Delta neutrophyl index for thyroid malignancies

  The correlation between DNI and thyroid cancer

  retrospective 5 year

• Immature granulocyte count for thyroid malignancies

  The correlation between DNI and thyroid cancer

  retrospective 5 year

• Neutrophyl to lymphocyte ratio for thyroid malignancies

  The correlation between DNI and thyroid cancer

  retrospective 5 year

Study Arms (3)

Thyroid Malignancy

ACTIVE COMPARATOR

Thyroidectomy

Diagnostic Test: Complete Blood Count

Benign Thyroidal Goitor

SHAM COMPARATOR

Thyroidectomy

Diagnostic Test: Complete Blood Count

Control Group

OTHER

Selective lichtenstein procedure for inguinal hernia

Diagnostic Test: Complete Blood Count

Interventions

Complete Blood Count DIAGNOSTIC_TEST

Complete Blood Count samples

Also known as: Thyroidectomy

Benign Thyroidal Goitor; Control Group; Thyroid Malignancy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Related Publications (11)

• 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

  BACKGROUND

• 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.

  PMID: 32041420 BACKGROUND

• 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: 30241494 BACKGROUND

• 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.

  PMID: 11229684 BACKGROUND

• 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.

  PMID: 27282249 BACKGROUND

• Bastid J, Bonnefoy N, Eliaou JF, Bensussan A. Lymphocyte-derived interleukin-17A adds another brick in the wall of inflammation-induced breast carcinogenesis. Oncoimmunology. 2014 Mar 27;3:e28273. doi: 10.4161/onci.28273. eCollection 2014.

  PMID: 25050201 BACKGROUND

• He JR, Shen GP, Ren ZF, Qin H, Cui C, Zhang Y, Zeng YX, Jia WH. Pretreatment levels of peripheral neutrophils and lymphocytes as independent prognostic factors in patients with nasopharyngeal carcinoma. Head Neck. 2012 Dec;34(12):1769-76. doi: 10.1002/hed.22008. Epub 2012 Feb 9.

  PMID: 22318781 BACKGROUND

• 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: 30588200 BACKGROUND

• 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.

  PMID: 25987053 BACKGROUND

• Kim TY, Kim SJ, Kim YS, Lee JW, Park EJ, Lee SJ, Lee KJ, Cha YS. Delta neutrophil index as an early predictive marker of severe acute pancreatitis in the emergency department. United European Gastroenterol J. 2019 May;7(4):488-495. doi: 10.1177/2050640619838359. Epub 2019 Mar 14.

  PMID: 31065366 BACKGROUND

• Cibas ES, Ali SZ. The 2017 Bethesda System for Reporting Thyroid Cytopathology. Thyroid. 2017 Nov;27(11):1341-1346. doi: 10.1089/thy.2017.0500.

  PMID: 29091573 BACKGROUND

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Nodule; Thyroid Diseases

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Assistant

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: June 11, 2020
• Study Start: November 1, 2014
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share