Clinical trial NCT05245136: Augsburg Longitudinal Plasma Study for the Evaluation of Liquid Biopsy as Diagnostic Tool.
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Characteristics Disease
Metastatic Cancer
Solid Tumor
Lead sponsor: University Hospital Augsburg
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consists of patients with diagnosis of metastatic cancer at the 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.

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

Primary outcomes:
measure: Correlation of tumor mutations between tissue biopsy (TBx) and liquid biopsy (LBx) at diagnosis
timeFrame: through study completion, an average of 3 years
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
Secondary outcomes:
measure: Investigation of tumor heterogeneity as a prognostic marker
timeFrame: through study completion, an average of 3 years
measure: Correlation of known and potential oncogenic drivers in LBx with DCR
timeFrame: through study completion, an average of 3 years
measure: Correlation of known and potential oncogenic drivers in LBx with OS
timeFrame: through study completion, an average of 3 years
measure: Role of a single numeric value (Shannon-Heterogeneity Index) at diagnosis as a surrogate marker for tumor heterogeneity
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: University Hospital Augsburg
state: Bavaria
Study officials:
affiliation: UH Augsburg
name: Maximilian Schmutz, MD
role: PRINCIPAL_INVESTIGATOR
References: