NCT07626125

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 22, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2026

Completed
Last Updated

June 9, 2026

Status Verified

May 1, 2026

Enrollment Period

14 days

First QC Date

May 22, 2026

Last Update Submit

June 6, 2026

Conditions

Laryngeal LesionsSystemic Inflammatory Process

Keywords

Laryngeal lesionssystemic inflammatory processpanimmun inflamation

Outcome Measures

Primary Outcomes (1)

  • Determining the diagnostic accuracy of PIV

    PIV (pan-immune-inflammation value)

    Postoperative 1 month

Secondary Outcomes (6)

  • Determining the diagnostic accuracy of NLR

    Postoperative 1 month

  • Determining the diagnostic accuracy of PLR

    Postoperative 1 month

  • Determining the diagnostic accuracy of HEO

    Postoperative 1 month

  • Determining the diagnostic accuracy of SII

    Postoperative 1 month

  • Determining the diagnostic accuracy of NPAR

    Postoperative 1 month

  • +1 more secondary outcomes

Study Arms (9)

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

Laryngeal polypsOTHER

Bening laryngeal lesions

Laryngeal polyps
Laryngeal nodulesOTHER

Bening laryngeal lesions

Laryngeal nodules
Laryngeal cystsOTHER

Bening laryngeal lesions

Laryngeal cysts
Reinke's edemaOTHER

Bening laryngeal lesions

Reinke's edema
PapillomasOTHER

Premalign laryngeal lesions

Papillomas
DysplasiaOTHER

Premalign laryngeal lesions

Dysplasia
High-risk premalignant lesionsOTHER

Premalign laryngeal lesions

High-risk premalignant lesions
Malignant vocal cord lesionsOTHER

Malign laryngeal lesions

Malignant vocal cord lesions
Asymptomatic smokers without vocal cord lesionsOTHER

None laryngeal lesions

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Antalya Training and Research Hospital

Antalya, Muratpaşa, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 40086488BACKGROUND

  • 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.

    PMID: 36565325BACKGROUND

Study Officials

  • Nuray Ensari

    University of Health Sciences, Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuray Ensari

CONTACT

+905055025177nurayakmese@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2026

First Posted

June 4, 2026

Study Start

May 22, 2026

Primary Completion

June 5, 2026

Study Completion

June 19, 2026

Last Updated

June 9, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)