An Investigation of Biomarker Candidate Molecules in Laryngeal Carcinoma

Sponsor

Hacettepe University (Other)

Overall Status

Completed

CT.gov ID

NCT05217147

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Larynx Cancer Larynx Carcinoma	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 Design

Study Type:

Observational

Actual Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2018

Actual Primary Completion Date :

Feb 1, 2020

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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
Stage [Basal]
Disease stage as stage as early (I-II) or late (III-IV)
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 (%)
Tumor grade [Basal]
Tumor grade as poor, moderate or well
Recurrence status [18 months after reaching the target patient number]
Recurrence status as yer or no
Tumor localization [Basal]
Tumor localization as glottic/supraglottic or transglottic
Treatment modality [Basal]
Treatment modality as surgical, non-surgical or combined

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

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.