Clinical trial NCT05319483: The Clinical, Epidemiological and Treatment Characteristics of Head and Neck Cancer Patients
Official title: The Clinical, Epidemiological and Treatment Characteristics of Head and Neck Cancer Patients Presenting to Different Levels of the Health Care System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Waiting Times, Patient Pathways, Effect of Lifestyle-related, Clinical and Demographic Parameters on Outcomes
Keywords: Head and neck cancer, Survival, Waiting times, Patient pathways
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years or over with primary head-neck cancer (with morphology of squamocellular carcinoma, ICD codes: C00-C14, C32) and no previously documented cancer.

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.

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

Primary outcomes:
measure: Characterization of patient pathways
timeFrame: 2021-2024
measure: Lifestyle-related factors
timeFrame: 2021-2026
measure: Hard endpoint outcomes: Overall survival, time to metastasis, disease-free survival
timeFrame: 2021-2029
Secondary outcomes:
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: University of Pécs, Clinical Centre
state: Baranya
Study officials:
References: