Идёт набор NCT05741073

Outcome Research of a European Registry Platform on Real-world Treatment Data of Patients with Advanced NMSC

— Наблюдательное Basal Cell Carcinoma Cutaneous Squamous Cell Carcinoma

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Basal Cell Carcinoma, Cutaneous Squamous Cell 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: Бельгия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This current registry study will analyze real-world data to address questions about disease characteristics and treatment patterns in NMSC patients based on the European NMSC-Registry. The overall objective is to describe characteristics, management and treatment outcomes for patients presenting with advanced NMSC (cSCC/BCC) or HR-cSCC in routine clinical practice, independent of treatments used across different European regions.

Подробное описание

Skin cancer is one of the most common cancers worldwide, and the most frequent cancer in the white population. Incidence rates of NMSC are increasing, partly attributable to more outdoor leisure activities and aging population. Among NMSC, basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC) are the most predominant histologic subtypes. Real-world data especially those systematically recorded in registries are limited. With limited resources, many cancer databases do not register all primary NMSCs. For advanced patients with NMSC, the EUMelaReg consortium (EMR) introduces a registry specific for NMSC across Europe (EMR-NMSC) which brings together national registries and operates as a higher-level registry. The aim of this registry is to collect real-world data of the available diagnosis and treatment pattern of advanced NMSC patients at a European level. Data of the EMR NMSC-Registry can be used for specific pre-defined analyses regarding drugs, availability and affordability of various treatments for different patient populations, data on health-related resource utilization, outcome data, and risk factors.

Quality management Study participating sites are responsible for recording and verifying the accuracy of subject data.

A data management plan (DMP) will be in place which describes the life cycle of the study data from the collection to archiving, including all measures to ensure that the data remain available, usable and comprehensible. It includes rules and regulations for e.g. data validation, data processing, medical coding, quality review procedures and archiving of study documentation. National and international data protection laws as well as regulations on registries will be followed.

Data validation Detailed information on checks for completeness, accuracy, plausibility and validity are given in the data validation plan (DVP). The computerized handling of the data by the service provider may generate requests to which the participating site needs to respond by confirming or modifying the data questioned.

Первичные конечные точки

Real-world demographics in routine clinical practice [Срок оценки: min. 2 years up to max 5 years of observation]

Вторичные конечные точки (12)

Tumor characteristics [Срок оценки: min. 2 years up to max 5 years of observation]
Treatment patterns [Срок оценки: min. 2 years up to max 5 years of observation]
Overall survival [Срок оценки: min. 2 years up to max 5 years of observation]
Adverse drug reactions [Срок оценки: min. 2 years up to max 5 years of observation]
Treatment discontinuation [Срок оценки: min. 2 years up to max 5 years of observation]
Time to progression (TTP) - for advanced BCC only [Срок оценки: min. 2 years up to max 5 years of observation]
Time to progression (TTP) - for advanced cSCC [Срок оценки: min. 2 years up to max 5 years of observation]
Time to next treatment (TTNT) - for advanced cSCC, advanced BCC only [Срок оценки: min. 2 years up to max 5 years of observation]
Time to treatment discontinuation (TTD) - for advanced cSCC, advanced BCC only [Срок оценки: min. 2 years up to max 5 years of observation]
Progression free survival (PFS) - for advanced cSCC, advanced BCC only [Срок оценки: min. 2 years up to max 5 years of observation]
Overall response rate (ORR) - for advanced cSCC, advanced BCC only [Срок оценки: min. 2 years up to max 5 years of observation]
Time to recurrence (TTR) [Срок оценки: min. 2 years up to max 5 years of observation]

Критерии участия

Критерии включения

Patients aged ≥18 years at index date
Patients documented in the European NMSC-registry fulfilling EMR quality standard
Patients with resected HR-cSCC (Cohort 1) receiving only postoperative radiotherapy or watchful waiting OR Patients with advanced cSCC who are not candidates for curative surgery/radiation in routine clinical practice (Cohort 2) OR Patients with advanced BCC who are not candidates for curative surgery/radiation in routine clinical practice (Cohort 3)