CClinicalTrials.gg
RecruitingNCT05245136ALPSUpdated Jul 30, 2026

Augsburg Longitudinal Plasma Study for the Evaluation of Liquid Biopsy as Diagnostic Tool.

An observational study in Characteristics Disease, Metastatic Cancer and Solid Tumor, sponsored by University Hospital Augsburg. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by University Hospital Augsburg · Observational

From the registry’s dates

  • Started Mar 2021; still recruiting 5 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Characteristics Disease
  • Metastatic Cancer
  • Solid Tumor

Browse trials for

03

In context

Neoplasm Metastasis

3,514 studies on the registry are indexed under Neoplasm Metastasis; 883 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 121 across 593 observational studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

University Hospital Augsburg is the lead sponsor of 24 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Study population consists of patients with diagnosis of metastatic cancer at the University Hospital Augsburg.

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

Exclusion Criteria:

  • Psychological condition that would preclude informed consent
  • Additional tumor treatment between acquisition of tumor tissue and trial inclusion
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

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 years

  2. 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 months

Secondary 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 years

  2. 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 years

  3. 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 years

  4. 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 years

07

Study locations

1 of 1 sites recruiting
  • University Hospital Augsburg
    Augsburg, Bavaria 86156, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05245136
Lead sponsor
University Hospital Augsburg
Responsible party
Sponsor
First posted
Feb 17, 2022
Start date
Mar 29, 2021
Primary completion
Nov 2029 (estimated)
Completion
Mar 2030 (estimated)
Last update
Jul 30, 2026

Study contacts

Sommer Sebastian, MD
Contact
sebastian.sommer@uk-augsburg.de
+49-821400 ext. 161027
Rainer Claus, MD
Contact
rainer.claus@uk-augsburg.de
+49-821400 ext. 3715
Maximilian Schmutz, MD
principal investigator · UH Augsburg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion