An Investigation of Biomarker Candidate Molecules in Laryngeal Carcinoma

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

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.

Study Overview

• Status: Completed
• Conditions: Larynx Cancer; Larynx Carcinoma
• Intervention / Treatment: Other: Obtaining blood samples

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study included 60 patients who were prospectively and consecutively recruited from those who admitted to Hacettepe University, Department of Otorhinolaryngology, Ankara, Turkey. 20 healthy and age-matched controls were chosen from the hospital staff and relatives of the patients.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient group; 60 patients with laryngeal carcinoma	Other: Obtaining blood samples; Blood samples were obtained at time of diagnosis and will be analyzed for the levels of biomarker candidate molecules.
Control group; 20 healthy age- and sex- matched controls	Other: Obtaining blood samples; Blood samples were obtained at time of diagnosis and will be analyzed for the levels of biomarker candidate molecules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum levels of biomarker candidate molecules	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	Basal
Stage	Disease stage as stage as early (I-II) or late (III-IV)	Basal
Diagnostic sensitivity and specifity of biomarker candidate molecules	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 (%)	Basal
Tumor grade	Tumor grade as poor, moderate or well	Basal
Recurrence status	Recurrence status as yer or no	18 months after reaching the target patient number
Tumor localization	Tumor localization as glottic/supraglottic or transglottic	Basal
Treatment modality	Treatment modality as surgical, non-surgical or combined	Basal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival analysis parameters	All the patients were contacted for survival analysis. Overall and disease-free survival will be measured in months and survival rates will be calculated in percentages (%). Overall survival and disease-free survival rates will be calculated according to levels of biomarker candidate molecules and assessed for any association with any molecule.	18 months after reaching the target patient number

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Gurcan Gunaydin, MD, PhD, Hacettepe University Cancer Institute; Study Chair: Nilda Suslu, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: biomarker; larynx carcinoma; endoglin; angiogenin; vegf; svegfr-1; vegfr-2; osteoponitn
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Carcinoma; Laryngeal Neoplasms; Laryngeal Diseases
• Other Study ID Numbers: THD-2019-18414

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