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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Characteristics Disease, Metastatic Cancer, Solid Tumor

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Psychological condition that would preclude informed consent Additional tumor treatment between acquisition of tumor tissue and trial inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |