Clinical trial NCT05217147: An Investigation of Biomarker Candidate Molecules in Laryngeal Carcinoma
Official title: An Investigation of Clinical Parameters and Biomarkers Associated With Angiogenesis, Proliferation, Cell Adhesion and Invasion in Laryngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Larynx Cancer
Larynx Carcinoma
Keywords: larynx carcinoma
angiogenin
endoglin
vegf
svegfr-1
vegfr-2
osteoponitn
biomarker
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum levels of biomarker candidate molecules
timeFrame: Basal
measure: Stage
timeFrame: Basal
measure: Diagnostic sensitivity and specifity of biomarker candidate molecules
timeFrame: Basal
measure: Tumor grade
timeFrame: Basal
measure: Recurrence status
timeFrame: 18 months after reaching the target patient number
measure: Tumor localization
timeFrame: Basal
measure: Treatment modality
timeFrame: Basal
Secondary outcomes:
measure: Survival analysis parameters
timeFrame: 18 months after reaching the target patient number
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Cancer Institute
Study officials:
affiliation: Hacettepe University Cancer Institute
name: Gurcan Gunaydin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Nilda Suslu
role: STUDY_CHAIR
References: