Идёт набор NCT05245136

Augsburg Longitudinal Plasma Study for the Evaluation of Liquid Biopsy as Diagnostic Tool.

— Наблюдательное Characteristics Disease Metastatic Cancer Solid Tumor

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: Characteristics Disease, Metastatic Cancer, Solid Tumor. 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: Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Augsburg Longitudinal Plasma Study (ALPS) to Study Liquid Biopsy (LBx) as a Tool for Diagnostic Support, Assessment of Disease Progression, and Identification of Mutations During Disease Course in Patients With Solid Neoplasms Receiving Palliative Treatment

Обзор

A prospective observational trial of patients with metastatic cancer of various entities which aims at both clarifying the significance of liquid biopsy and establishing a foundation for translational research.

Подробное описание

ALPS is a prospective observational trial to assess liquid biopsy as diagnostic tool in patients with various metastatic neoplasms. Liquid biopsy will be correlated not only with the tissue biopsy, but also to imaging modalities and classical tumor markers. In addition, the study aims to investigate clonal heterogeneity and evolution of different cancers during patient treatment courses. A third aspect of the study is to survey and assess patients' knowledge about biomarkers and personalized medicine in general and about liquid biopsy as a new diagnostic tool.

Первичные конечные точки

Correlation of tumor mutations between tissue biopsy (TBx) and liquid biopsy (LBx) at diagnosis [Срок оценки: through study completion, an average of 3 years]
Concordance between TBx and LBx at disease progression [Срок оценки: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months]

Вторичные конечные точки (4)

Investigation of tumor heterogeneity as a prognostic marker [Срок оценки: through study completion, an average of 3 years]
Correlation of known and potential oncogenic drivers in LBx with DCR [Срок оценки: through study completion, an average of 3 years]
Correlation of known and potential oncogenic drivers in LBx with OS [Срок оценки: through study completion, an average of 3 years]
Role of a single numeric value (Shannon-Heterogeneity Index) at diagnosis as a surrogate marker for tumor heterogeneity [Срок оценки: through study completion, an average of 3 years]

Критерии участия

Критерии включения

Written informed consent
Age ≥ 18 years
Histopathologically confirmed metastatic or locally advanced cancer
No curative treatment options, except for germ cell tumors
Written Agreement to be followed up at Augsburg University Medical Center
Signed written informed consent for the Biobank Augsburg (Biobank-A)
Willing to undergo treatment according to standard of care
Availability or anticipated availability of tumor tissue at time point of inclusion
Anticipated life expectancy of at least 3 months at time point of trial inclusion