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Not yet recruitingNCT07626125SILVCLUpdated Jun 9, 2026

Systemic Inflammatory Markers In Vocal Cord Lesions

An observational study in Laryngeal Lesions and Systemic Inflammatory Process, sponsored by Antalya Health Sciences University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by Antalya Health Sciences University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to evaluate the levels of systemic inflammatory markers such as PIV, SII, and NPAR in patients with benign and premalignant laryngeal lesions and to determine the diagnostic accuracy of these values using ROC analysis.

Read the detailed description

Benign laryngeal lesions are generally nodules, polyps, or cysts that form due to overuse of the voice or vocal cord trauma. Reinke's edema, also within this group, is a benign laryngeal condition characterized by the accumulation of gelatinous fluid in the superficial lamina propria of the vocal cords. It is usually associated with chronic irritation, particularly smoking, and is frequently seen in middle-aged individuals with a long history of tobacco use. Previous experimental studies have shown that cigarette smoke triggers inflammatory responses in vocal cord fibroblasts and increases the production of inflammatory mediators. The cellular and systemic inflammatory processes triggered by irritation due to chronic smoking are still not fully understood. In recent years, systemic inflammation markers derived from routine hemogram parameters have attracted attention as low-cost and reliable potential biomarkers in various inflammatory and neoplastic diseases. Neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte ratio (PLR), hemoglobin-eosinophil ratio (HEO), systemic immune-inflammation index (SII), and pan-immune-inflammation value (PIV), as well as more comprehensive indices reflecting both inflammatory and nutritional status such as Neutrophil-Albumin Ratio (NPAR) and HALP (Hemoglobin, Albumin, Platelet Ratio), are inexpensive and readily available indicators of systemic inflammation. However, a review of the literature reveals a lack of studies examining the relationship between benign and malignant laryngeal lesions and systemic inflammation through these comprehensive indices (PIV and NPAR). The aim of this study is to evaluate the levels of systemic inflammatory markers such as PIV, SII, and NPAR in patients with benign and premalignant laryngeal lesions and to determine the diagnostic accuracy of these values using ROC analysis.

02

Conditions studied

  • Laryngeal Lesions
  • Systemic Inflammatory Process

Keywords

  • Laryngeal lesions
  • systemic inflammatory process
  • panimmun inflamation
03

In context

Lead sponsor

Antalya Health Sciences University is the lead sponsor of 15 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Inclusion was planned for patients aged 18 and over, with a diagnosis of vocal cord lesion via endoscopic or surgical means, and with complete blood count and albumin data in hospital records.

Inclusion criteria

  • Patients aged 18 years and older
  • Patients with a diagnosis of vocal cord lesion via endoscopic or surgical means
  • Patients with complete blood count and albumin data in their hospital records

Exclusion criteria

Exclusion Criteria:

  • Acute infection
  • Autoimmune disease
  • Other malignancy
  • Steroid use
  • Hematological disease
  • Systemic inflammatory disease
  • Missing laboratory data
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • Laryngeal polyps

    Other: Laryngeal polyps

  • Laryngeal nodules

    Other: Laryngeal nodules

  • Laryngeal cysts

    Other: Laryngeal cysts

  • Reinke's edema

    Other: Reinke's edema

  • Papillomas

    Other: Papillomas

  • Dysplasia

    Other: Dysplasia

  • High-risk premalignant lesions

    Other: High-risk premalignant lesions

  • Malignant vocal cord lesions

    Other: Malignant vocal cord lesions

  • Control

    Other: Asymptomatic smokers without vocal cord lesions

Interventions

  • OtherLaryngeal polyps

    Bening laryngeal lesions

  • OtherLaryngeal nodules

    Bening laryngeal lesions

  • OtherLaryngeal cysts

    Bening laryngeal lesions

  • OtherReinke's edema

    Bening laryngeal lesions

  • OtherPapillomas

    Premalign laryngeal lesions

  • OtherDysplasia

    Premalign laryngeal lesions

  • OtherHigh-risk premalignant lesions

    Premalign laryngeal lesions

  • OtherMalignant vocal cord lesions

    Malign laryngeal lesions

  • OtherAsymptomatic smokers without vocal cord lesions

    None laryngeal lesions

06

What researchers measure

Primary outcomes

  1. Determining the diagnostic accuracy of PIV

    PIV (pan-immune-inflammation value)

    Time frame: Postoperative 1 month

Secondary outcomes

  1. Determining the diagnostic accuracy of NLR

    NLR (neutrophil-lymphocyte ratio)

    Time frame: Postoperative 1 month

  2. Determining the diagnostic accuracy of PLR

    PLR (platelet-lymphocyte ratio)

    Time frame: Postoperative 1 month

  3. Determining the diagnostic accuracy of HEO

    HEO (hemoglobin-eosinophil ratio)

    Time frame: Postoperative 1 month

  4. Determining the diagnostic accuracy of SII

    SII (systemic immune-inflammation index)

    Time frame: Postoperative 1 month

  5. Determining the diagnostic accuracy of NPAR

    NPAR (neutrophil-albumin ratio)

    Time frame: Postoperative 1 month

  6. Determining the diagnostic accuracy of HALP

    HALP (hemoglobin, albumin, platelet ratio)

    Time frame: Postoperative 1 month

07

Study locations

1 site
  • University of Health Sciences, Antalya Training and Research Hospital
    Antalya, Muratpaşa, Turkey (Türkiye)
08

References and documents

Publications

  • Pan L, Yu Z, Xiang WX, Sun SR, Li JX, Deng YK, Wang MC, Zhong JX, Huang K, Gao PS, Zhu LP, Yao Y, Liu Z. Cigarette smoke-induced epithelial cell ferroptosis promotes neutrophilic inflammation in patients with nasal polyps. J Allergy Clin Immunol. 2025 Jun;155(6):1882-1897. doi: 10.1016/j.jaci.2025.02.034. Epub 2025 Mar 12. PubMed 40086488 ↗
  • Guven DC, Erul E, Yilmaz F, Yasar S, Yildirim HC, Ercan F, Kaygusuz Y, Cayiroz K, Ucdal MT, Yesil F, Yazici G, Cengiz M, Gullu I, Aksoy S. The association between pan-immune-inflammation value and survival in head and neck squamous cell carcinoma. Eur Arch Otorhinolaryngol. 2023 May;280(5):2471-2478. doi: 10.1007/s00405-022-07804-x. Epub 2022 Dec 24. PubMed 36565325 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07626125
Lead sponsor
Antalya Health Sciences University
Responsible party
Sponsor
First posted
Jun 4, 2026
Start date
May 22, 2026 (estimated)
Primary completion
Jun 5, 2026 (estimated)
Completion
Jun 19, 2026 (estimated)
Last update
Jun 9, 2026

Study contacts

Nuray Ensari
Contact
nurayakmese@yahoo.com
+905055025177
Nuray Ensari
principal investigator · University of Health Sciences, Antalya Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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