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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation 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) | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, an average of 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Study population consists of patients with diagnosis of metastatic cancer at the University Hospital Augsburg.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sommer Sebastian, MD | Contact | +49-821400 | 161027 | sebastian.sommer@uk-augsburg.de |
| Rainer Claus, MD | Contact | +49-821400 | 3715 | rainer.claus@uk-augsburg.de |
| Name | Affiliation | Role |
|---|---|---|
| Maximilian Schmutz, MD | UH Augsburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Augsburg | Recruiting | Augsburg | Bavaria | 86156 | Germany |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Samples retained, with potential for extraction of DNA from at least one of the types of samples retained (FFPE-tissue, whole blood, plasma)
| 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 |
| 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 | 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 | to evaluate the role of a single numeric value (Shannon-Heterogeneity Index) at diagnosis as a surrogate marker for tumor heterogeneity | through study completion, an average of 3 years |