Systemic Inflammatory Markers In Vocal Cord Lesions (SILVCL)

May 29, 2026 updated by: Antalya Health Sciences University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Other: Asymptomatic smokers without vocal cord lesions
None laryngeal lesions
Laryngeal polyps
Other: Laryngeal polyps
Bening laryngeal lesions
Laryngeal nodules
Other: Laryngeal nodules
Bening laryngeal lesions
Laryngeal cysts
Other: Laryngeal cysts
Bening laryngeal lesions
Reinke's edema
Other: Reinke's edema
Bening laryngeal lesions
Papillomas
Other: Papillomas
Premalign laryngeal lesions
Dysplasia
Other: Dysplasia
Premalign laryngeal lesions
High-risk premalignant lesions
Other: High-risk premalignant lesions
Premalign laryngeal lesions
Malignant vocal cord lesions
Other: Malignant vocal cord lesions
Malign laryngeal lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determining the diagnostic accuracy of PIV
Time Frame: Postoperative 1 month
PIV (pan-immune-inflammation value)
Postoperative 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determining the diagnostic accuracy of other systemic inflammatory markers
Time Frame: Postoperative 1 month
NLR (neutrophil-lymphocyte ratio), PLR (platelet-lymphocyte ratio), HEO (hemoglobin-eosinophil ratio), SII (systemic immune-inflammation index), NPAR (neutrophil-albumin ratio), HALP (hemoglobin, albumin, platelet Ratio)
Postoperative 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Health Sciences University

Investigators

  • Principal Investigator: Nuray Ensari, University of Health Sciences, Antalya Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 22, 2026

Primary Completion (Estimated)

June 5, 2026

Study Completion (Estimated)

June 19, 2026

Study Registration Dates

First Submitted

May 22, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 7/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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