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NCT Number: NCT07626125

Systemic Inflammatory Markers In Vocal Cord Lesions

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences, Antalya Training and Research Hospital

Antalya, Muratpaşa, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Laryngeal polyps

Other

Bening laryngeal lesions

Laryngeal nodules

Other

Bening laryngeal lesions

Laryngeal cysts

Other

Bening laryngeal lesions

Reinke's edema

Other

Bening laryngeal lesions

Papillomas

Other

Premalign laryngeal lesions

Dysplasia

Other

Premalign laryngeal lesions

High-risk premalignant lesions

Other

Premalign laryngeal lesions

Malignant vocal cord lesions

Other

Malign laryngeal lesions

Asymptomatic smokers without vocal cord lesions

Other

None laryngeal lesions

Primary outcomes

  1. Determining the diagnostic accuracy of PIV

    Time frame: Postoperative 1 month

    PIV (pan-immune-inflammation value)

Secondary outcomes

  1. Determining the diagnostic accuracy of NLR

    Time frame: Postoperative 1 month

    NLR (neutrophil-lymphocyte ratio)

  2. Determining the diagnostic accuracy of PLR

    Time frame: Postoperative 1 month

    PLR (platelet-lymphocyte ratio)

  3. Determining the diagnostic accuracy of HEO

    Time frame: Postoperative 1 month

    HEO (hemoglobin-eosinophil ratio)

  4. Determining the diagnostic accuracy of SII

    Time frame: Postoperative 1 month

    SII (systemic immune-inflammation index)

  5. Determining the diagnostic accuracy of NPAR

    Time frame: Postoperative 1 month

    NPAR (neutrophil-albumin ratio)

  6. Determining the diagnostic accuracy of HALP

    Time frame: Postoperative 1 month

    HALP (hemoglobin, albumin, platelet ratio)

Study contacts

Contact information is provided by the study sponsor or research team.

Nuray Ensari

CONTACT

[email protected]

+905055025177

Sponsors and collaborators

Lead sponsor

Antalya Health Sciences University

Other

Registry information

Official study title

Comparison Of Sysstemic Inflammatory Markers And Panimmune-Inflammatory Values In Patients With Beningn, Premalingnant And Malingnant Vocal Cord Lesions

Acronym: SILVCL

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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