Идёт набор NCT03862677
Determining Prognostic Immune Markers in Patients With Ovarian 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
- В протоколе указаны: No intervention.
- Кому может быть актуально
- Состояния в реестре: Epithelial Ovarian Cancer. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
The IMPRoVE study is a prospective, non-interventional, explorative cohort study to determine prognostic immune markers in patients with epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (EOC).
Подробное описание
Tumor material, ascites (if possible) and blood samples for immune monitoring will be collected from patients with primary and recurrent EOC undergoing surgery, chemotherapy and/or immunotherapy.
Вмешательства
- Другое No intervention
Observational study, no intervention
Первичные конечные точки
- Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and OS [Срок оценки: 5 years]
Вторичные конечные точки (12)
- Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and PFS [Срок оценки: 5 years]
- Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and OS [Срок оценки: 5 years]
- Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and PFS [Срок оценки: 5 years]
- Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on OS [Срок оценки: 5 years]
- Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on PFS [Срок оценки: 5 years]
- Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and OS [Срок оценки: 5 years]
- Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and OS [Срок оценки: 5 years]
- Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and PFS [Срок оценки: 5 years]
- Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and PFS [Срок оценки: 5 years]
- Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with OS [Срок оценки: 5 years]
- Function of myeloid cells (assessed by functional suppression assay) in PBMCs in patients with primary EOC before and during treatment and the association with OS [Срок оценки: 5 years]
- Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with OS [Срок оценки: 5 years]
Критерии участия
Критерии включения
- Patients with (suspicion of) primary or recurrent EOC with an indication for surgery, chemotherapy and/or immunotherapy.
- Age ≥18 years.
- WHO performance status 0-2.
- Accessible for treatment and follow-up.
- Written informed consent.
Критерии исключения
- Other active malignancy in past 5 years prior to entry into the study, except for treated non-melanoma skin cancer.
- Any known severe infection like HIV, hepatitis A, B and C.
- Receiving immune suppressive treatment.
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Нидерланды · 1 центр
- Leiden University Medical Center — Leiden
Идентификаторы
NCT: NCT03862677 · NL66869.058.19