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Clinical Trials/NCT05319483
NCT05319483
Recruiting
N/A

The Clinical, Epidemiological and Treatment Characteristics of Head and Neck Cancer Patients Presenting to Different Levels of the Health Care System

University of Pecs1 site in 1 country100 target enrollmentOctober 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Waiting Times, Patient Pathways, Effect of Lifestyle-related, Clinical and Demographic Parameters on Outcomes
Sponsor
University of Pecs
Enrollment
100
Locations
1
Primary Endpoint
Lifestyle-related factors
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

The aim of our study is to prospectively collect information regarding (1) the demographic, lifestyle-related and clinical characteristics of patients with head and neck cancer and (2) the waiting times to diagnosis and therapy, and the 1-, 3- and 5-year survival of patients. We plan to gain insight into the characteristics and pathways of head and neck cancer patients in Baranya County, which can in turn help to identify factors that lead to improved or worse disease outcomes. (Thus, these factors can subsequently eliminated or lessened to improve the outcome of head and neck cancer patients. )

Detailed Description

The aim of our study is to prospectively collect information regarding (1) the demographic, lifestyle-related and clinical characteristics of patients (including initial symptoms) with head and neck cancer and (2) the patient pathways and waiting times to diagnosis and therapy, the 1-, 3- and 5-year survival, and time to metastasis of patients. Study design: Prospective data collection and analysis, based on data collected from the clinic's electronic eMedSol database and questionnaire (regarding demographic, lifestyle and patient pathway-related data) filled in by interviewing patient. We plan to monitor lifestyle parameters of patients (such as oral hygiene, alcohol consumption and smoking, the knowledge of patients about risk factors of head and neck cancers,etc) and clinical parameters such as time and type of first symptom, ECOG state, comorbidities, clinical stage, diagnostic workups, etc. at predetermined time intervals (upon first ENT presentation, and at 3-, 6-, 12-, and 24 month intervals. Disease progression (time to metastasis) and overall survival will be assessed at the given time points. By gathering data and gaining insight into the characteristics, pathways and survival of head and neck cancer patients we aim to identify factors that may lead to improved or worse disease outcomes.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
October 1, 2029
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients 18 years or over presenting with head and neck cancer (with morphology of squamocellular carcinoma), who are subsequently given one of the following ICD-10 codes: Malignant neoplasms of lip, oral cavity and pharynx (C00-C14), Malignant neoplasm of larynx (C32) and for whom this is their first cancer.

Exclusion Criteria

  • Patients who do not meet the inclusion criteria and patients who meet the inclusion criteria but for whom this is a second or recurrent cancer (they already have an "ICD-C" code) are excluded from the study

Outcomes

Primary Outcomes

Lifestyle-related factors

Time Frame: 2021-2026

The effects of demographic and lifestyle-related factors on clinical outcome(s) using follow-up data

Hard endpoint outcomes: Overall survival, time to metastasis, disease-free survival

Time Frame: 2021-2029

Assessment of overall survival, time to metastasis, disease-free survival

Characterization of patient pathways

Time Frame: 2021-2024

Initial symptoms, waiting times to diagnosis and treatment, type of healthcare provision

Study Sites (1)

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