Идёт набор NCT05354765

Exploration of Adaptive Antitumoral Immune Cells Through Lymphapheresis in Cancer Patients : ALCYTA

Без фазы С лечением Cancer Immune System or Toxicities Suspected

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: blood sample, blood sample.
Кому может быть актуально: Состояния в реестре: Cancer, Immune System or Toxicities Suspected. 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 →

The study will evaluate the detection of tumor-antigen specific immune cells in cancer patients in whom the role of the immune system is suspected.

Другое blood sample
lymphapheresis before and during treatment, blood sample in CellSave® tubes (15mL) will be taken at baseline and three weeks, and EDTA tubes (15mL) will be taken at baseline, 3 weeks after treatment start and at progression
Другое blood sample
lymphapheresis will be performed between 8 weeks and 18 months after the start of treatment

Evaluation of the presence of tumor-antigen specific T cells for Cohorts A [Срок оценки: before treatment]
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A [Срок оценки: During treatment]
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A [Срок оценки: at baseline]
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A [Срок оценки: 3 weeks after treatment start]
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A [Срок оценки: at progression (up to 100 weeks)]
Evaluation of the presence of tumor-antigen specific T cells for Cohorts B [Срок оценки: between 8 weeks and 18 months after the start of treatment]

Patient aged 18 or over,
Patient presenting an invasive tumor pathology (proven or suspected). The location and / or stage of which are defined for each cohort through an amendment to the protocol,
Patient treated with immune-modulators or other treatments likely to modify immunological parameters,
Suspicion of immune mediated response or toxicities (assessed by the immunologists),
Peripheral venous capital usable and compatible with the realization of 2 venous accesses for lymphapheresis and absence of cardiovascular problem (heart failure, arrhythmia ...), per investigator assessement,
Total circulating lymphocytes> 1000 / mm3,
Availability of DNA and RNA from the tumor,
Information to the patient and signature of informed consent or his legal representative,
Affiliated with a social security scheme or such a scheme.

Inability to undergo study follow-up for geographical, social or psychological reasons,
Infection with HIV or hepatitis B or C viruses,
Patients on high dose corticosteroid treatment (> 1 mg / kg continuously),
Any concomitant serious illness that may interfere with participation in the study or significantly affect the results of the study (pulmonary, heart or liver disease),
Contraindication to performing lymphapheresis (coagulation disorder, cardiovascular problems, venous access, hypocalcemia, psychological inability to undergo extracorporeal circulation, cachexia, etc.),
Pregnant patient or of childbearing age without effective contraception,
Persons deprived of their liberty, under guardianship or legal protection.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Франция · 2 центра

NCT: NCT05354765 · IC 2020-12

Бесплатно. Мы поможем связаться с центром и подготовить документы; решение об участии принимает врач исследовательского центра.