An Investigation of Biomarker Candidate Molecules in Laryngeal Carcinoma

NCT05217147 | Completed

• 1 other identifier: THD-2019-18414
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Larynx Cancer; Larynx Carcinoma

Keywords

larynx carcinoma; angiogenin; endoglin; vegf; svegfr-1; vegfr-2; osteoponitn; biomarker

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Survival analysis parameters

  18 months after reaching the target patient number

Study Arms (2)

Patient group

60 patients with laryngeal carcinoma

Other: Obtaining blood samples

Control group

20 healthy age- and sex- matched controls

Other: Obtaining blood samples

Interventions

Obtaining blood samples OTHER

Blood samples were obtained at time of diagnosis and will be analyzed for the levels of biomarker candidate molecules.

Control group; Patient group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Cancer Institute

Ankara, 06100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Officials

• Gurcan Gunaydin, MD, PhD

  Hacettepe University Cancer Institute

  PRINCIPAL INVESTIGATOR

• Nilda Suslu

  Hacettepe University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 1, 2022
• Study Start: May 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: August 31, 2021
• Last Updated: September 22, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)