Augsburg Longitudinal Plasma Study for the Evaluation of Liquid Biopsy as Diagnostic Tool.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Augsburg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent
Age ≥ 18 years
Histopathologically confirmed metastatic or locally advanced cancer
No curative treatment options, except for germ cell tumors
Disqualifiers
Psychological condition that would preclude informed consent
Additional tumor treatment between acquisition of tumor tissue and trial inclusion
Trial population
Study population consists of patients with diagnosis of metastatic cancer at the University Hospital Augsburg.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Correlation of tumor mutations between tissue biopsy (TBx) and liquid biopsy (LBx) at diagnosis
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)
Time frame
through study completion, an average of 3 years2
Concordance between TBx and LBx at disease progression
Concordance between TBx and LBx at disease progression with TBx as reference method based on PPA (positive percent agreement) and NPA (negative percent agreement)
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 monthsSecondary outcomes
1
Investigation of tumor heterogeneity as a prognostic marker
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
Time frame
through study completion, an average of 3 years2
Correlation of known and potential oncogenic drivers in LBx with DCR
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
Time frame
through study completion, an average of 3 years3
Correlation of known and potential oncogenic drivers in LBx with OS
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
Time frame
through study completion, an average of 3 years4
Role of a single numeric value (Shannon-Heterogeneity Index) at diagnosis as a surrogate marker for tumor heterogeneity
to evaluate the 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 yearsSponsors and contacts
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Source ClinicalTrials.gov