Impact of Epigenetic Age on Clinic-biological Presentation and Prognosis in Myeloproliferative Neoplasms Epigenetic Age in Myeloproliferative Neoplasms (EpiC)
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: Assessment of the epigenetic age.
- Кому может быть актуально
- Состояния в реестре: Myeloproliferative Neoplasm. 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
Myeloproliferative Neoplasms (MPN) are hematological malignancies characterized by the excessive production of myeloid cells. MPN can be complicated by thrombosis and evolution into more aggressive diseases (myelofibrosis and acute leukemia). Aging remains the principal factor determining patients' survival in MPN. In recent years, DNA methylation has appeared as a mean to measure aging via the development of epigenetic clocks that have also been associated with the occurrence of thrombosis and cancer. The epiC project aims at determining epigenetic age of MPN patients and search for an association between this parameter and thrombotic/hematological complications.
Подробное описание
Myeloproliferative Neoplasia (MPN) are hematological malignancies characterized by the excessive production of myeloid cells. They include Essential Thrombocythemia (ET), Polycythemia Vera (VP) and Primary Myelofibrosis (PMF). Thrombosis are the most frequent complications and are largely responsible for the morbidity and mortality observed in ET and PV patients. The most feared complications are hematological transformations (into myelofibrosis for PV and ET, into acute myeloid leukemia for PV, ET and PMF). The prognostic assessment of MPN patients is mainly based on clinical data. Although recent studies have shown that certain mutations are associated with a poorer prognosis, age remains the main risk factor affecting survival in MPN patients. Recent studies have shown that DNA methylation can be used to determine an "epigenetic age". Interestingly, this epigenetic age is associated with the development of cardiovascular disease and cancer.
In this project, the epigenetic age of MPN patients will be determined by studying the DNA methylation at diagnosis using the Infinium Human MethylationEPIC kit (Illumina). Epigenetic age will be determined with the most commonly used epigenetic clocks (DNAmAge, DNAmHannum, DNAmPhenoAge, DNAmSkinClock, DNAmGrimAge, intrinsic epigenetic age acceleration, extrinsic epigenetic age acceleration). It will be searched for an association between accelerated epigenetic aging (as assessed by the difference between epigenetic age and chronological age) and the type of MPN, the clinical and biological presentation at diagnosis (including the mutational profile of patients) and the occurrence of thrombosis and hematological evolution into myelofibrosis and/or acute leukemia.
Вмешательства
- Биопрепарат Assessment of the epigenetic age
Retrospective assessment of the epigenetic age on DNA samples obtained at diagnosis
Первичные конечные точки
- Accelerated ageing of patients [Срок оценки: At inclusion, up to 1 year after diagnosis]
Вторичные конечные точки (10)
- Type of MPN (ET, PV or PMF) at diagnosis [Срок оценки: At inclusion, up to 1 year after diagnosis]
- Transformation into secondary myelofibrosis or acute leukemia [Срок оценки: From date of inclusion until documentation of the event, assessed up to 5 years]
- Occurrence of thrombosis prior to diagnosis or during follow-up of the disease [Срок оценки: Between 1 year before and 2 years after MPN diagnosis]
- Leukocytes [Срок оценки: At inclusion, up to 1 year after diagnosis]
- Platelets [Срок оценки: At inclusion, up to 1 year after diagnosis]
- Granulocytes [Срок оценки: At inclusion, up to 1 year after diagnosis]
- Monocytes [Срок оценки: At inclusion, up to 1 year after diagnosis]
- Hemoglobin [Срок оценки: At inclusion, up to 1 year after diagnosis]
- Hematocrit [Срок оценки: At inclusion, up to 1 year after diagnosis]
- Additional somatic mutation [Срок оценки: At inclusion, up to 1 year after diagnosis]
Критерии участия
Критерии включения
For the 110 patients with MPN:
- Patients with PV, ET or PMF
- DNA extracted from purified granulocytes at time of diagnosis
- No treatment likely to impact DNA methylation (chemotherapy, immunosuppressants in particular)
For the 10 subjects without MPN:
- Absence of hematological malignancy
- Search for JAK2V617F mutation in the context of reactive thrombocytosis or secondary polycythemia
- Absence of treatment likely to impact DNA methylation (chemotherapy, immunosuppressants in particular)
Критерии исключения
For the 110 patients with MPN:
- Patients without PV, ET or PMF
- Patients without purified granulocytes DNA available at time of diagnosis
- Patients treated by cytoreductive drug, demethylating agent, chemotherapy or immunosuppressive therapy at the time of DNA sampling
- Patients with less than 2 years' follow-up
For the 10 subjects in NMP :
- Patients with hematological malignancy and/or solid cancer
- Patients treated by cytoreductive drug, demethylating agent, chemotherapy or immunosuppressive therapy at the time of DNA sampling
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- CHU de Bordeaux, service Hématologie Biologique — Bordeaux
Идентификаторы
NCT: NCT06022328 · CHUBX 2023/15