Clinical trial · Observational
Augsburg Longitudinal Plasma Study for the Evaluation of Liquid Biopsy as Diagnostic Tool.
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
NCT05245136CI-TRIAL-00119837ALPSrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Characteristics Disease | — | UNRESOLVED | — |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Correlation of tumor mutations between tissue biopsy (TBx) and liquid biopsy (LBx) at diagnosis
- timeFrame
- through study completion, an average of 3 years
- description
- 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)
- measure
- Concordance between TBx and LBx at disease progression
- timeFrame
- 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
- description
- 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 outcomes (4)
- measure
- Investigation of tumor heterogeneity as a prognostic marker
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.