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.
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 Type
OBSERVATIONAL
Enrollment
80
Blood samples were obtained at time of diagnosis and will be analyzed for the levels of biomarker candidate molecules.
Hacettepe University Cancer Institute
Ankara, Turkey (Türkiye)
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
Time frame: Basal
Stage
Disease stage as stage as early (I-II) or late (III-IV)
Time frame: 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 (%)
Time frame: Basal
Tumor grade
Tumor grade as poor, moderate or well
Time frame: Basal
Recurrence status
Recurrence status as yer or no
Time frame: 18 months after reaching the target patient number
Tumor localization
Tumor localization as glottic/supraglottic or transglottic
Time frame: Basal
Treatment modality
Treatment modality as surgical, non-surgical or combined
Time frame: Basal
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.
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Time frame: 18 months after reaching the target patient number