An Investigation of Biomarker Candidate Molecules in Laryngeal Carcinoma

Completed

• Conditions: Larynx Cancer; Larynx Carcinoma
• Interventions: Other: Obtaining blood samples

• Registration Number: NCT05217147
• Lead Sponsor: Hacettepe University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-05-01
• Primary Completion: 2020-02-01
• Study Completion: 2021-08-31
• Status Verified: 2022-01
• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-02-01
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient group	Obtaining blood samples	60 patients with laryngeal carcinoma
Control group	Obtaining blood samples	20 healthy age- and sex- matched controls

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Survival analysis parameters	18 months after reaching the target patient number	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.

Trial Locations

Locations (1)

Hacettepe University Cancer Institute; 🇹🇷 Ankara, Turkey