Идёт набор NCT04424719

Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)

Без фазы С лечением Uveal Melanoma

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 test.
Кому может быть актуально: Состояния в реестре: Uveal Melanoma. 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

Biomarkers search for early diagnosis of liver metastases in patients with uveal melanoma who benefit from a follow-up tailored to their personalized risk of relapse.

Подробное описание

High risk patients are referred for the medical oncology consultation to organize oncological surveillance after general staging of the disease. Signature of the informed consent of SALOME study, inclusion in the study and risk-adjusted surveillance schedule :

(i) Liver MRI every 6 months performed at the expert center for UM (according to guidelines).

(ii) For enucleated patients, a blood sample (3 x 6 ml EDTA tubes) is taken every 6 months according to the schedule below. Plasma and mononucleated cells will be isolated and preserved for bio-markers research.

* M0 : during the first medical oncology visit. * At each imaging assessment, every 6 months for at least 5 years (M6 to M60) and 10 years maximum (M120). * At the diagnosis of metastasis. * At each significant event during the metastatic disease (surgery, treatment response or progression).

Вмешательства

Другое Blood test
High risk patients are referred for the medical oncology consultation to organize oncological surveillance after general staging of the disease. Signature of the informed consent of SALOME study, inclusion in the study and risk-adjusted surveillance schedule : (i) Liver MRI every 6 months performed at the expert center for UM (according to guidelines). (ii) For enucleated patients, a blood sample (3 x 6 ml EDTA tubes) is taken every 6 months according to the schedule below. Plasma and mononucl

Первичные конечные точки

Description of the metastatic events and treatments in high risk UM patients and correlation to biomarkers [Срок оценки: 120 months]
Biological study (lymphocytes) [Срок оценки: 120 months]
Biological study (ctDNA) [Срок оценки: 120 months]

Вторичные конечные точки (8)

Biological samples prospective collection (ctDNA) [Срок оценки: 120 months]
Biological samples prospective collection (immune-monitoring analyses) [Срок оценки: 120 months]
Biological samples prospective collection (sequencing analyses) [Срок оценки: 120 months]
Comparison of clinical and imaging data (MRI) [Срок оценки: 120 months]
Comparison of clinical and imaging data (clinical data) [Срок оценки: 120 months]
Univariate analysis of the prognostic value of identified biomarkers [Срок оценки: 120 months]
Multivariate analysis of the prognostic value of identifies biomarkers adjusted for clinical and imaging data [Срок оценки: 120 months]
Analysis of discordant cases regarding genomic/tumor size prognostic factors and outcomes [Срок оценки: 120 months]

Критерии участия

Критерии включения

Patient aged of 18 years or more.
Patient with uveal melanoma with high metastatic relapse risk defined as :

T2b/c/d ou ≥ T3,
or chromosom 3 or chromosom 8 abnormality by CGH array.
Completion of treatment of the primary tumor ≤ 2 months.
Patient able to comply with the schedule of visits and blood samples of the study.
Signed informed consent form or legal representative.