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.
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.
Study Type
OBSERVATIONAL
Enrollment
3,000
University Hospital Augsburg
Augsburg, Bavaria, Germany
RECRUITINGCorrelation of tumor mutations between tissue biopsy (TBx) and liquid biopsy (LBx) at diagnosis
Correlation of tumor mutations between TBx and LBx at diagnosis with TBx as reference method based on PPA (positive percent agreement) and NPA (negative percent agreement)
Time frame: through study completion, an average of 3 years
Concordance between TBx and LBx at disease progression
Concordance between TBx and LBx at disease progression with TBx as reference method based on PPA (positive percent agreement) and NPA (negative percent agreement)
Time frame: 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
Investigation of tumor heterogeneity as a prognostic marker
Correlation of known and potential oncogenic drivers with imaging modalities based on morphological therapeutic response: ORR in classical entities and pools of tumor entities with ≥ 40 patient sample size
Time frame: through study completion, an average of 3 years
Correlation of known and potential oncogenic drivers in LBx with DCR
Correlation of known and potential oncogenic drivers with imaging modalities based on morphological therapeutic response: DCR in classical entities and pools of tumor entities with ≥ 40 patient sample size
Time frame: through study completion, an average of 3 years
Correlation of known and potential oncogenic drivers in LBx with OS
Correlation of presence of known and potential oncogenic drivers in LBx with OS per classical tumor entities and pools of tumor entities with ≥ 100 patient sample size
Time frame: through study completion, an average of 3 years
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Role of a single numeric value (Shannon-Heterogeneity Index) at diagnosis as a surrogate marker for tumor heterogeneity
to evaluate the role of a single numeric value (Shannon-Heterogeneity Index) at diagnosis as a surrogate marker for tumor heterogeneity
Time frame: through study completion, an average of 3 years