Augsburg Longitudinal Plasma Study for the Evaluation of Liquid Biopsy as Diagnostic Tool.
- Conditions
- Metastatic CancerCharacteristics DiseaseSolid Tumor
- Registration Number
- NCT05245136
- Lead Sponsor
- University Hospital Augsburg
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- 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
- Psychological condition that would preclude informed consent
- Additional tumor treatment between acquisition of tumor tissue and trial inclusion
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Concordance between TBx and LBx at disease progression 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 Concordance between TBx and LBx at disease progression with TBx as reference method based on PPA (positive percent agreement) and NPA (negative percent agreement)
Correlation of tumor mutations between tissue biopsy (TBx) and liquid biopsy (LBx) at diagnosis through study completion, an average of 3 years 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)
- Secondary Outcome Measures
Name Time Method Investigation of tumor heterogeneity as a prognostic marker through study completion, an average of 3 years 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
Correlation of known and potential oncogenic drivers in LBx with OS through study completion, an average of 3 years 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
Correlation of known and potential oncogenic drivers in LBx with DCR through study completion, an average of 3 years 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
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 to evaluate the role of a single numeric value (Shannon-Heterogeneity Index) at diagnosis as a surrogate marker for tumor heterogeneity
Trial Locations
- Locations (1)
University Hospital Augsburg
🇩🇪Augsburg, Bavaria, Germany