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Clinical Trials/NCT05217147
NCT05217147CompletedNot Applicable

An Investigation of Clinical Parameters and Biomarkers Associated With Angiogenesis, Proliferation, Cell Adhesion and Invasion in Laryngeal Carcinoma

Hacettepe University1 site in 1 country80 target enrollmentStarted: May 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
Diagnostic sensitivity and specifity of biomarker candidate molecules

Study Overview

Brief Summary

The aim of this study was to determine serum levels of VEGF, sVEGFR1, VEGFR2, IGFBP-3, angiogenin and endoglin in patients with larynx squamous cell carcinoma; investigate their association with clinical parameters and determine their diagnostic and prognostic value.

Detailed Description

Although there has been a significant increase in survival in many other cancer types through the years, no significant increase has been achieved in laryngeal SCC survival rates in the last 50 years. Despite the advancements in surgical techniques, organ preservation protocols and multidisciplinary approach, significant amount of patients have been living with morbidity or dying due to recurrence and metastasis. This lack of significant improvement in mortality rates creates the need for reliable and accurate biomarkers in early diagnosis, treatment and follow-up. Considering that the prognosis of two patients at the same clinical stage and treated with the same treatment protocol may differ, it suggests that there may be some differences at the molecular level apart from clinical stages.

This study was mainly prepared to determine serum levels of VEGF, sVEGFR1, VEGFR2, IGFBP-3, angiogenin and endoglin in patients with larynx squamous cell carcinoma; investigate their association with clinical parameters and determine their diagnostic and prognostic value.

To reach these aims, 60 patients who were prospectively and consecutively recruited from those who admitted to Hacettepe University, Department of Otorhinolaryngology, Ankara, Turkey, and were diagnosed with LSCC between May 2018 and February 2020. 20 healthy and age-matched controls were chosen from the hospital staff and relatives of the patients. Serum samples were obtained from all participants at the time of diagnosis, centrifuged and stored at -80 C. ELISA method will be used to analyze the serum levels of VEGF, sVEGFR1, VEGFR2, IGFBP-3, angiogenin and endoglin.

Data analysis will reveal if there are any association between biomarker candidate molecules and clinical parameters.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 60 male or female patients with a newly diagnosed laryngeal squamous cell carcinoma
  • Patients without any previous history of laryngeal carcinoma
  • 20 healthy, age- and sex- matched controls

Exclusion Criteria

  • Previous history of laryngeal squamous cell carcinoma
  • Having comorbid systemic diseases like DM, hypertension, cardiologic or rheumatologic diseases
  • Having malign tumors elsewhere
  • History of chemotherapy/radiotherapy.

Outcomes

Primary Outcomes

Diagnostic sensitivity and specifity of biomarker candidate molecules

Time Frame: Basal

Receiver operating characteristic analysis will be performed to determine a significant level of any biomarker candidate molecules for diagnostic sensitivity and sensitivity. Sensitivity and specifity as percentages (%)

Recurrence status

Time Frame: 18 months after reaching the target patient number

Recurrence status as yer or no

Treatment modality

Time Frame: Basal

Treatment modality as surgical, non-surgical or combined

Tumor localization

Time Frame: Basal

Tumor localization as glottic/supraglottic or transglottic

Stage

Time Frame: Basal

Disease stage as stage as early (I-II) or late (III-IV)

Serum levels of biomarker candidate molecules

Time Frame: Basal

Serum levels of: VEGF in pg/ml sVEGFR1 in pg/ml VEGFR2 in pg/ml IGFBP-3 in pg/ml angiogenin in pg/ml and endoglin in pg/ml will be determined in all participants

Tumor grade

Time Frame: Basal

Tumor grade as poor, moderate or well

Secondary Outcomes

  • Survival analysis parameters(18 months after reaching the target patient number)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gurcan GUNAYDIN, MD, PhD

Associate Professor

Hacettepe University

Study Sites (1)

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