An Investigation of Biomarker Candidate Molecules in Laryngeal Carcinoma

NCT ID: NCT05217147

Last Updated: 2023-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2021-08-31

Brief Summary

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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

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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.

Conditions

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Larynx Cancer Larynx Carcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

20 healthy age- and sex- matched controls

Obtaining blood samples

Intervention Type OTHER

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

Patient group

60 patients with laryngeal carcinoma

Obtaining blood samples

Intervention Type OTHER

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

Interventions

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Obtaining blood samples

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

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Gurcan GUNAYDIN, MD, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gurcan Gunaydin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University Cancer Institute

Nilda Suslu

Role: STUDY_CHAIR

Hacettepe University

Locations

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Hacettepe University Cancer Institute

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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THD-2019-18414

Identifier Type: -

Identifier Source: org_study_id

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