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Completed

NCT Number: NCT05217147

An Investigation of Biomarker Candidate Molecules in Laryngeal Carcinoma

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.

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Key information

Conditions

Larynx Cancer Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Larynx Carcinoma Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University Cancer Institute

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Obtaining blood samples

Other

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

Primary outcomes

  1. Serum levels of biomarker candidate molecules

    Time frame: 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

  2. Stage

    Time frame: Basal

    Disease stage as stage as early (I-II) or late (III-IV)

  3. Diagnostic sensitivity and specifity of biomarker candidate molecules

    Time frame: 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 (%)

  4. Tumor grade

    Time frame: Basal

    Tumor grade as poor, moderate or well

  5. Recurrence status

    Time frame: 18 months after reaching the target patient number

    Recurrence status as yer or no

  6. Tumor localization

    Time frame: Basal

    Tumor localization as glottic/supraglottic or transglottic

  7. Treatment modality

    Time frame: Basal

    Treatment modality as surgical, non-surgical or combined

Secondary outcomes

  1. Survival analysis parameters

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Feb 1, 2022
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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