Systemic Inflammatory Markers In Vocal Cord Lesions (SILVCL)

June 6, 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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determining the diagnostic accuracy of NLR
Time Frame: Postoperative 1 month
NLR (neutrophil-lymphocyte ratio)
Postoperative 1 month
Determining the diagnostic accuracy of PLR
Time Frame: Postoperative 1 month
PLR (platelet-lymphocyte ratio)
Postoperative 1 month
Determining the diagnostic accuracy of HEO
Time Frame: Postoperative 1 month
HEO (hemoglobin-eosinophil ratio)
Postoperative 1 month
Determining the diagnostic accuracy of SII
Time Frame: Postoperative 1 month
SII (systemic immune-inflammation index)
Postoperative 1 month
Determining the diagnostic accuracy of NPAR
Time Frame: Postoperative 1 month
NPAR (neutrophil-albumin ratio)
Postoperative 1 month
Determining the diagnostic accuracy of HALP
Time Frame: Postoperative 1 month
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Antalya Health Sciences University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 19, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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