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Идёт набор NCT07210671

Prospective Evaluation of the Treatment of Cancer Associated Superficial Venous

— Наблюдательное Superficial Vein Thrombosis Cancer Venous Thrombosis

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Superficial Vein Thrombosis, Cancer, Venous Thrombosis. 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

Superficial venous thrombosis (SVT) is very common in clinical practice. What's more, around 15- 20% of SVTs occur in the context of cancer. Today, cancer patients are excluded from therapeutic trials for DVT. There is therefore no high-level evidence-based treatment recommendation for these patients. Recent data suggest that the course of cancer-associated DVT is similar to that of cancer-associated deep vein thrombosis (DVT). However, there are currently few prospective data on the evolution of cancer-associated DVT in relation to the treatment used. Due to the absence of clear recommendations of treatment in case of SVT associated with cancer the investigators will perform a prospective observational study to evaluate the efficacy of different regiment of anticoagulant treatment ordered in clinical practice.

Первичные конечные точки

  • risk (in %) of recurrence of VTE [Срок оценки: at 3-month follow-up]
Вторичные конечные точки (12)
  • association (%) between initial treatment and the risk of SVT recurrence [Срок оценки: at 3 months]
  • association (%) between initial treatment and the risk of SVT recurrence [Срок оценки: at 6 months]
  • association (%) between initial treatment and the risk of SVT recurrence [Срок оценки: at 12 months]
  • Association (%) between initial treatment and the occurrence of pulmonary embolism (PE) [Срок оценки: at 12 months]
  • Association (%) between initial treatment and the occurrence of pulmonary embolism (PE) [Срок оценки: at 3 months]
  • Association (%) between initial treatment and the occurrence of DVT [Срок оценки: at 3 months]
  • Association (%) between initial treatment and the occurrence of pulmonary embolism (PE) [Срок оценки: at 6 months]
  • Association (%) between initial treatment and the occurrence of DVT [Срок оценки: at 12 months]
  • Association (%) between initial treatment and the occurrence of DVT [Срок оценки: at 6 months]
  • association (%) between initial treatment and bleeding events [Срок оценки: at 6 months]
  • association (%) between initial treatment and bleeding events [Срок оценки: at 3 months]
  • association (%) between initial treatment and bleeding events [Срок оценки: at 12 months]

Критерии участия

Критерии включения

  • Patient over 18
  • Patient affiliated to a social security scheme
  • Patient who understands French
  • Patient with superficial venous thrombosis of the lower and upper limbs confirmed by a Doppler ultrasound less than one month old.
  • Patient with active cancer:
  • Cancer treatment within the last 6 months,
  • Detectable tumor disease, cancer treatment within the last 6 months, ongoing hormone therapy for cancer, palliative cancer.
  • The patient has received potentially non-curative cancer treatment (notably palliative chemotherapy).
  • Progression shows that the cancer treatment was not curative (due to recurrence or progression under treatment) (particularly in the case of recurrence after surgery)

Критерии исключения

  • Patients under legal protection
  • Patients with concomitant pulmonary embolism
  • Patient with proximal or distal deep vein thrombosis
  • Patient treated with anticoagulant therapy for another indication
  • Patient with a contraindication to anticoagulation: Thrombocytopenia less than 30,000 elements/mm3, active bleeding or history of severe bleeding.
  • Patient opposed to participation in research

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Франция · 1 центр
  • CHU Amiens — Amiens

Идентификаторы

NCT: NCT07210671 · PI2024_843_0121

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗