Идёт набор NCT04457713

Off-label Use of Anti-cancer Drugs in Norway -a Prospective Cohort Study

— Наблюдательное Cancer

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: Cancer. 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: Норвегия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Off-label drug use, where a marketed drug is used outside its approved indication, may allow early access to new and promising treatments. However, its use can be a source of controversy, due to limited evidence for clinical benefit and lack of cost/QALY-estimates, leading to challenging prioritization issues. The number of drugs suitable for off-label use is expected to further increase in the coming years, owing to the rapid progress in the field of oncology, in particular with the current era of precision medicine and targeted therapies. This also challenges the traditional method of running clinical trials, with eligible patient populations commonly being small, underpinning the importance of gaining supplementary real-world evidence from well performed observational studies. This prospective observational study will therefore assess real-world outcomes of patients treated with off-label anti-cancer drugs, including efficacy in terms of response rates, time to progression/relapse measures and survival; patient-reported outcome measures (PROMS) and self-reported side-effects/toxicity; as well as collecting blood samples for a biobank for further translational research. Further, the study will give a descriptive analysis of the current practice of off-label use of anti-cancer drugs in Norway, including prevalence estimation and health care related cost analyses.

Первичные конечные точки

Progression free survival (PFS). [Срок оценки: Assessed up to 2 years after end of inclusion]
Patients questionnaire EORTC QLQ-C30 [Срок оценки: Assessed from inclusion until 2 years after end of treatment]

Вторичные конечные точки (9)

Objective tumor response rate (ORR) [Срок оценки: Assed through study completion, an average of 1 year]
Duration of response (DR) [Срок оценки: Assed through study completion, an average of 1 year]
Time to next treatment (TTNT) [Срок оценки: Assed through study completion, an average of 1 year]
Overall survival (OS) [Срок оценки: Assessed up to 2 years after end of inclusion]
Fatigue [Срок оценки: From inclusion until 2 years after end of treatment]
Depression [Срок оценки: From inclusion until 2 years after end of treatment]
Pain intensity [Срок оценки: From inclusion until 2 years after end of treatment]
Adverse event [Срок оценки: From inclusion until 2 years after end of treatment]
Quality adjusted life years (QALYs) [Срок оценки: From inclusion until 2 years after end of treatment]

Критерии участия

Критерии включения

Verified cancer diagnosis (based on radiological, histological/cytological or operative evidence).
Treatment with off-label anti-cancer drug.
Age ≥ 18 years
Able to provide written informed consent.