Thyroid Cancer Clinical Trial
Official title:
Delta Neutrophil Index and Neutrophil Lymphocyte Ratio in Differentiation of Thyroid Malignancy and Nodular Goiter
NCT number | NCT04425512 |
Other study ID # | 355 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2014 |
Est. completion date | November 1, 2019 |
Verified date | June 2020 |
Source | Kahramanmaras Sutcu Imam University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 333 |
Est. completion date | November 1, 2019 |
Est. primary completion date | November 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Kahramanmaras Sutcu Imam University |
Balkwill F, Mantovani A. Inflammation and cancer: back to Virchow? Lancet. 2001 Feb 17;357(9255):539-45. Review. — View Citation
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. eCollection 2014. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View 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. 2020 Feb 10:145561320902855. doi: 10.1177/0145561320902855. [Epub ahead of print] — View 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
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delta neutrophyl index for thyroid malignancies | The correlation between DNI and thyroid cancer | retrospective 5 year | |
Primary | Immature granulocyte count for thyroid malignancies | The correlation between DNI and thyroid cancer | retrospective 5 year | |
Primary | Neutrophyl to lymphocyte ratio for thyroid malignancies | The correlation between DNI and thyroid cancer | retrospective 5 year |
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