An Investigation of Biomarker Candidate Molecules in Laryngeal Carcinoma

Larynx Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05217147
• Other study ID #: THD-2019-18414
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: January 2022
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 31, 2021
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Laryngeal Diseases
• Laryngeal Neoplasms
• Larynx Cancer
• Larynx Carcinoma

Intervention

Other:
• Obtaining blood samples
Blood samples were obtained at time of diagnosis and will be analyzed for the levels of biomarker candidate molecules.

Locations

Country	Name	City	State
Turkey	Hacettepe University Cancer Institute	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Stage	Disease stage as stage as early (I-II) or late (III-IV)	Basal
Primary	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
Primary	Tumor grade	Tumor grade as poor, moderate or well	Basal
Primary	Recurrence status	Recurrence status as yer or no	18 months after reaching the target patient number
Primary	Tumor localization	Tumor localization as glottic/supraglottic or transglottic	Basal
Primary	Treatment modality	Treatment modality as surgical, non-surgical or combined	Basal
Secondary	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