AIOCC Italian Registry on Head and Neck Carcinomas
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: observational-retrospective and prospective.
- Кому может быть актуально
- Состояния в реестре: Head and Neck Carcinoma. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Multicentre, retrospective and prospective observational study aimed to set-up a clinical Italian registry in order to collect information on carcinoma of the Head and Neck.
Подробное описание
The registry plans to collect data on all patients treated or followed for Head and Neck cancer by the HCP of selected investigational sites in Italy.
Data will be entered manually by HCP staff of each investigational site in the study e-CRF in order to populate the AIR study database. Authorized HCPs will be provided with personal UserID and Password for the access to study eCRF.
For Data analysis an open-source system called Vantage6 will be used. It is a privacy preserving federated learning infrastructure for the secure exchange and analysis of incorporating data located at different sources. Queries will be issued to interrogate the database in order to have descriptive statistics and relevant information to plan the statistical analyses envisioned by the study protocol.
The registry data will support observational studies based on the second hand use of available data. Data collected for the AIR Study could be used also for global collaborative studies performed in Europe and outside the Europe.
Вмешательства
- Другое observational-retrospective and prospective
observational-retrospective and prospective
Первичные конечные точки
- types of diagnostic and treatment patterns [Срок оценки: From the enrollment to the end of the study (5 years)]
Вторичные конечные точки (10)
- proportion of patients in the different stage of disease [Срок оценки: From the enrollment to the end of the study (5 years)]
- treatment outcomes [Срок оценки: From the enrollment to the end of the study (5 years)]
- patients and disease characteristics [Срок оценки: From the enrollment to the end of the study (5 years)]
- benchmark values [Срок оценки: From the enrollment to the end of the study (5 years)]
- healthcare resource [Срок оценки: From the enrollment to the end of the study (5 years)]
- prognostic factors [Срок оценки: From the enrollment to the end of the study (5 years)]
- between differences in mortality and differences in medical practice [Срок оценки: From the enrollment to the end of the study (5 years)]
- potential benefit [Срок оценки: From the enrollment to the end of the study (5 years)]
- immunization [Срок оценки: From the enrollment to the end of the study (5 years)]
- econometric approach [Срок оценки: From the enrollment to the end of the study (5 years)]
Критерии участия
Критерии включения
- Adult patients (age ≥ 18 years old) diagnosed with carcinoma of the Head and Neck. The diagnosis should be done or verified by the expert site entering the information about the patient in the registry. Patients diagnosed with sarcomas and lymphomas are excluded.
- Patients entering the HCP at any clinical phase of the disease (diagnosis, treatment of primary cancer, treatment of recurrence, treatment of M+ etc.). The HCP will collect information on the entire disease regardless of when it started to manage the patient. The HCP can choose, based on its resources, for how many patients will be able to collect the data.
- New patients managed by the HCP from 2021 onwards + patients managed by the HCP, in active follow-up at the hospital
Критерии исключения
1\. Patients whose medical records are unavailable for review
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Италия · 7 центров
- Fondazione del Piemonte per l'Oncologia - IRCCS — Candiolo
- A.O.U. Careggi — Florence
- P.O. 'Vito Fazzi' — Lecce
- Fondazione IRCCS Istituto Nazionale Tumori — Milan
- Fondazione CNAO — Pavia
- Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS — Roma
- Azienda Ospedaliera Universitaria Integrata di Verona — Verona
Идентификаторы
NCT: NCT06248944 · AIR Study