Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy
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: ImmuCCo Cohort.
- Кому может быть актуально
- Состояния в реестре: Solid Tumor, Adult. 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
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
ImmuCCo-1905 is a monocentric interventional study on patients treated by immunotherapy, which consist in establishment of a prospective clinic-biologic database over 5 years, associated with a biobank. This database will allow carrying out works aiming at assessing immunotherapy in real life situation.
Подробное описание
The aim of this study is to establish a prospective clinic-biologic database of patients treated by immunotherapy. This database will allowed to carry out works (such as translational research) aiming at assessing immunotherapy in real life situation.
Other objectives of the study include:
* Describe overall survival, progression-free survival, response to immunotherapy (in particular hyper-progression, pseudo-progression) considering the first tumor assessment and the best response, prolonged response * Identifying prognostic factors of overall survival, progression-free survival, hyper-progression, best response under immunotherapy * Describe AEs (Adverse Events) potentially associated with immunotherapy, their kinetics of appearance, from the start of treatment and after the end of treatment in order to assess the risk of delayed appearance * To identify factors associated with increased risk of severe adverse event (grade \> 2 or leading to end of treatment) potentially related to immunotherapy, from the beginning of immunotherapy to 1 year after this start of the treatment, in patients who received at least 4 doses or who stopped the treatment earlier (before 4 doses) due to toxicity. * Identifying delayed adverse events potentially related to immunotherapy, occurring between 90 days and 1 year after the treatment discontinuation, in patients who received at least 4 doses or who stopped the treatment earlier (before 4 doses) due to toxicity. * To identify and describe rare toxicities * To evaluate the association between co-medications and disease evolution * To evaluate the association between co-medications and toxicities occurrence
Translational research objectives:
* To identify biomarkers that might be associated with tumor response and/or toxicity of immunotherapy from:
* Establishment of serum and plasma bank which will be used for diverse works; * A systematic analysis of the lymphocyte profile * To study the impact of tabagism on efficacy and toxicity of immunotherapy from systematic collection of urinary cotinine.
Вмешательства
- Другое ImmuCCo Cohort
Blood sampling at initiation of immunotherapy, at the first tumor assessment, in case of severe toxicity. Urine collection at initiation of immunotherapy.
Первичные конечные точки
- Number of patients treated by immunotherapy and registered in the database. [Срок оценки: 5 years]
Вторичные конечные точки (5)
- Overall Survival [Срок оценки: 6 years]
- Progression-Free Survival [Срок оценки: 6 years]
- Tumor response [Срок оценки: 6 years]
- Co-medications [Срок оценки: 6 years]
- Toxicity of immunotherapy [Срок оценки: 6 years]
Критерии участия
Критерии включения
- Age ≥ 18 years
- Beginning a first immunotherapy by immune checkpoint inhibitor - anti-PD1 (Programmed cell Death protein-1), anti-PDL1 (Programmed cell Death protein-1 ligand), anti-CTLA4 (Cytotoxic T-Lymphocyte associated protein 4), as monotherapy or in combination, in the Centre Oscar Lambret (COL)
- In neo-adjuvant, adjuvant, recurrence or metastatic situation
- Suffering from solid tumor histologically documented
- Signed written informed consent
- Patient covered by the French " "Social Security" regime If the patient is already enrolled in clinical trial involving immunotherapy, the agreement of the sponsor of this new trial will be sought before his/her inclusion.
Критерии исключения
- Pregnant or breastfeeding women
- Patient already treated by immunotherapy by immune checkpoint inhibitor
- Person under guardianship
- Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Франция · 1 центр
- Centre Oscar Lambret — Lille
Идентификаторы
NCT: NCT05223608 · ImmuCCo-1905 · 2020-A00854-35