Augsburg Longitudinal Plasma Study for the Evaluation of Liquid Biopsy as Diagnostic Tool.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Characteristics Disease, Metastatic Cancer, Solid Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- Correlation of tumor mutations between tissue biopsy (TBx) and liquid biopsy (LBx) at diagnosis [Time frame: through study completion, an average of 3 years]
- Concordance between TBx and LBx at disease progression [Time frame: 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 (4)
- Investigation of tumor heterogeneity as a prognostic marker [Time frame: through study completion, an average of 3 years]
- Correlation of known and potential oncogenic drivers in LBx with DCR [Time frame: through study completion, an average of 3 years]
- Correlation of known and potential oncogenic drivers in LBx with OS [Time frame: 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 [Time frame: through study completion, an average of 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Hospital Augsburg — Augsburg
Identifiers
NCT: NCT05245136 · N67