Characteristics Disease, Metastatic Cancer, Solid Tumor
Conditions
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.
Interventions
None listed
Sponsors
University Hospital Augsburg
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
| 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 |
Countries
Germany
Contacts
CONTACTSommer Sebastian, MD
CONTACTRainer Claus, MD
PRINCIPAL_INVESTIGATORMaximilian Schmutz, MD
UH Augsburg
Outcome results
None listed