Laryngeal LesionsSILVCLNCT07626125
Systemic Inflammatory Markers In Vocal Cord Lesions
An observational study of Laryngeal Lesions and Systemic Inflammatory Process, run by Antalya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Lesions, Systemic Inflammatory Process
- What is being tested?
- Laryngeal polyps, Laryngeal nodules and Laryngeal cysts
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 May 2026to 19 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Acute infection
- Autoimmune disease
- Other malignancy
- Steroid use
- Hematological disease
- Systemic inflammatory disease
- Missing laboratory data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences, Antalya Training and Research Hospital
Antalya, Muratpaşa
About this study
Official title: 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.
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.
- Conditions
- Laryngeal Lesions, Systemic Inflammatory Process
- Being tested
- Laryngeal polyps, Laryngeal nodules, Laryngeal cysts, Reinke's edema, Papillomas
- Keywords
- Laryngeal lesions, systemic inflammatory process, panimmun inflamation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal polypsOther
Bening laryngeal lesions
Laryngeal nodulesOther
Bening laryngeal lesions
Laryngeal cystsOther
Bening laryngeal lesions
Reinke's edemaOther
Bening laryngeal lesions
PapillomasOther
Premalign laryngeal lesions
DysplasiaOther
Premalign laryngeal lesions
High-risk premalignant lesionsOther
Premalign laryngeal lesions
Malignant vocal cord lesionsOther
Malign laryngeal lesions
Asymptomatic smokers without vocal cord lesionsOther
None laryngeal lesions
| Study group | Role | What they receive |
|---|---|---|
| Laryngeal polyps | Not described Receives: Other: Laryngeal polyps | |
| Laryngeal nodules | Not described Receives: Other: Laryngeal nodules | |
| Laryngeal cysts | Not described Receives: Other: Laryngeal cysts | |
| Reinke's edema | Not described Receives: Other: Reinke's edema | |
| Papillomas | Not described Receives: Other: Papillomas | |
| Dysplasia | Not described Receives: Other: Dysplasia | |
| High-risk premalignant lesions | Not described Receives: Other: High-risk premalignant lesions | |
| Malignant vocal cord lesions | Not described Receives: Other: Malignant vocal cord lesions | |
| Control | Not described Receives: Other: Asymptomatic smokers without vocal cord lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the diagnostic accuracy of PIV
PIV (pan-immune-inflammation value)
Measured: Postoperative 1 month
Secondary outcomes (6)
Determining the diagnostic accuracy of NLR
NLR (neutrophil-lymphocyte ratio)
Measured: Postoperative 1 month
Determining the diagnostic accuracy of PLR
PLR (platelet-lymphocyte ratio)
Measured: Postoperative 1 month
Determining the diagnostic accuracy of HEO
HEO (hemoglobin-eosinophil ratio)
Measured: Postoperative 1 month
Determining the diagnostic accuracy of SII
SII (systemic immune-inflammation index)
Measured: Postoperative 1 month
Determining the diagnostic accuracy of NPAR
NPAR (neutrophil-albumin ratio)
Measured: Postoperative 1 month
Determining the diagnostic accuracy of HALP
HALP (hemoglobin, albumin, platelet ratio)
Measured: Postoperative 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start22 May 2026 (estimated)
- Primary completion5 Jun 2026 (estimated)
- Study completion19 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Laryngeal LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nuray Ensari, Principal investigator, University of Health Sciences, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626125
- Sponsor's protocol ID
- 7/14
- Acronym
- SILVCL
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 40086488Guven 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Sysstemic Inflammatory Markers And Panimmune-Inflammatory Values In Patients With Beningn, Premalingnant And Malingnant Vocal Cord Lesions
- ClinicalTrials.gov ID
- NCT07626125
- Acronym / sponsor ID
- SILVCL / 7/14
- Conditions
- Laryngeal Lesions, Systemic Inflammatory Process
- Keywords
- Laryngeal lesions, systemic inflammatory process, panimmun inflamation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Antalya Health Sciences UniversityUniversity, hospital or other
- Study start
- 22 May 2026 (estimated)
- Primary completion
- 5 Jun 2026 (estimated)
- Study completion
- 19 Jun 2026 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Acute infection
- Autoimmune disease
- Other malignancy
- Steroid use
- Hematological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laryngeal polypsBening laryngeal lesions | Other | Laryngeal polyps |
| Laryngeal nodulesBening laryngeal lesions | Other | Laryngeal nodules |
| Laryngeal cystsBening laryngeal lesions | Other | Laryngeal cysts |
| Reinke's edemaBening laryngeal lesions | Other | Reinke's edema |
| PapillomasPremalign laryngeal lesions | Other | Papillomas |
| DysplasiaPremalign laryngeal lesions | Other | Dysplasia |
| High-risk premalignant lesionsPremalign laryngeal lesions | Other | High-risk premalignant lesions |
| Malignant vocal cord lesionsMalign laryngeal lesions | Other | Malignant vocal cord lesions |
| Asymptomatic smokers without vocal cord lesionsNone laryngeal lesions | Other | Control |
Primary outcome
Determining the diagnostic accuracy of PIV
Time frame: Postoperative 1 month
PIV (pan-immune-inflammation value)
6 secondary outcomes
Determining the diagnostic accuracy of NLR
Time frame: Postoperative 1 month
Determining the diagnostic accuracy of PLR
Time frame: Postoperative 1 month
Determining the diagnostic accuracy of HEO
Time frame: Postoperative 1 month
Determining the diagnostic accuracy of SII
Time frame: Postoperative 1 month
Determining the diagnostic accuracy of NPAR
Time frame: Postoperative 1 month
Determining the diagnostic accuracy of HALP
Time frame: Postoperative 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 40086488Pan 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.
- Background: PubMed 36565325Guven 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nuray Ensari principal investigator
University of Health Sciences, Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Lesions and Systemic Inflammatory Process, run by Antalya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nuray Ensari (+905055025177, nurayakmese@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the diagnostic accuracy of PIV (time frame: Postoperative 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07626125, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.