The Value of Monitoring Circulating Cell DNA (ctDNA) in Pediatric Lymphoma: A Prospective, Multicenter Clinical Study
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: Pediatric lymphoma protocol.
- Кому может быть актуально
- Состояния в реестре: Lymphoma. Базовые параметры: 1 год — 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
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The next-generation sequencing (NGS) based on liquid biopsy has been an emerging technology to identify tumor-specific genetic aberrations in malignant tumors. The tumor tissue (FFPE) and plasma samples from the newly diagnosed pediatric lymphoma patients were collected and sequenced by 475 genes panel before, during and post treatment, to evaluate the significance of the ctDNA in efficacy prediction, predicting recurrence or mechanism of resistance to chemotherapy for pediatric lymphoma.
Подробное описание
This is a prospective, multi-center, observational cohort study. The tumor tissue (FFPE) and plasma samples (bone marrow or cerebrospinal fluid samples if necessary) from the newly diagnosed patients were collected and sequenced by 475 genes panel before, during and post treatment. Collection and analysis the results of ctDNA and chemotherapy response, to explore the mutation map of pediatric lymphoma and to evaluate the significance of liquid biopsy for efficacy prediction, predicting recurrence, mechanism of resistance to chemotherapy.
Вмешательства
- Препарат Pediatric lymphoma protocol
The tumor tissue (FFPE) and plasma samples (bone marrow or cerebrospinal fluid samples if necessary) from the newly diagnosed patients were collected and sequenced by 475 genes panel before, during and post treatment.
Первичные конечные точки
- The mutation rate of the ctDNA of pediatric lymphoma [Срок оценки: From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient]
Критерии участия
Критерии включения
- Children with pediatric lymphoma (HL and NHL) that met the criteria and required treatment upon histological and pathological diagnosis;
- Age: < 18 years old;
- The working status of the Eastern Cooperative Oncology Group (ECOG) (PS) : 0-2 points;
- CT/MRI measurable lesion was defined as the longest diameter of at least 1 lymph node ≥ 1.5cm, and it was clearly measurable in 2 vertical directions;
- Complete clinical laboratory examination and pathological examination information;
- Patients can be evaluated on time, and the required samples can be obtained throughout the testing process;
- After the patient is informed of the project, the informed consent signed by the patient or his legal representative is obtained.
Критерии исключения
- Patients with any of the following items will not be enrolled in this study:
- Incomplete baseline samples (preoperative plasma samples, tissue, bone marrow, cerebrospinal fluid) due to various reasons;
- The follow-up samples cannot be obtained during the monitoring process;
- The researcher considered it unsuitable for enrollment.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Yizhuo Zhang — Гуанчжоу
Идентификаторы
NCT: NCT04957901 · cDNA