The Clinical, Epidemiological and Treatment Characteristics of Head and Neck Cancer Patients Presenting to Different Levels of the Health Care System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Lifestyle-related factors
研究概览
简要总结
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. )
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Lifestyle-related factors
时间窗: 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
时间窗: 2021-2029
Assessment of overall survival, time to metastasis, disease-free survival
Characterization of patient pathways
时间窗: 2021-2024
Initial symptoms, waiting times to diagnosis and treatment, type of healthcare provision
次要结局
未报告次要终点