The Clinical, Epidemiological and Treatment Characteristics of Head and Neck Cancer Patients

Recruiting

• Conditions: Waiting Times, Patient Pathways, Effect of Lifestyle-related, Clinical and Demographic Parameters on Outcomes

• Registration Number: NCT05319483
• Lead Sponsor: University of Pecs

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.

Study Timeline

• Study Start: 2021-10-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-31
• Study First Submitted QC: 2022-03-31
• Last Update Submitted: 2022-03-31
• Study First Posted: 2022-04-08
• Last Update Posted: 2022-04-08
• Primary Completion: 2024-10-01
• Study Completion: 2029-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterization of patient pathways	2021-2024	Initial symptoms, waiting times to diagnosis and treatment, type of healthcare provision
Lifestyle-related factors	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	2021-2029	Assessment of overall survival, time to metastasis, disease-free survival

Trial Locations

Locations (1)

University of Pécs, Clinical Centre; 🇭🇺 Pécs, Baranya, Hungary