Characteristics DiseaseALPSNCT05245136
Augsburg Longitudinal Plasma Study for the Evaluation of Liquid Biopsy as Diagnostic Tool.
An observational study of Characteristics Disease and Metastatic Cancer, run by University Hospital Augsburg at 1 site in Germany.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Characteristics Disease, Metastatic Cancer, Solid Tumor
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- 29 Mar 2021to Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population consists of patients with diagnosis of metastatic cancer at the University Hospital Augsburg.
Who may be able to join
- 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)
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- 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
Who cannot join
- Psychological condition that would preclude informed consent
- Additional tumor treatment between acquisition of tumor tissue and trial inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Augsburg
Augsburg, Bavaria, 86156
About this study
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
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.
- Conditions
- Characteristics Disease, Metastatic Cancer, Solid Tumor
- Medical subject headings
- Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 3 years
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)
Measured: 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 (4)
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
Measured: through study completion, an average of 3 years
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
Measured: through study completion, an average of 3 years
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
Measured: 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
to evaluate the role of a single numeric value (Shannon-Heterogeneity Index) at diagnosis as a surrogate marker for tumor heterogeneity
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start29 Mar 2021
- Primary completionNov 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Characteristics DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maximilian Schmutz, MD, Principal investigator, UH Augsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245136
- Sponsor's protocol ID
- N67
- Acronym
- ALPS
- Status last verified
- Jul 2026
- First submitted
- 8 Nov 2021
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05245136
- Acronym / sponsor ID
- ALPS / N67
- Conditions
- Characteristics Disease, Metastatic Cancer, Solid Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population consists of patients with diagnosis of metastatic cancer at the University Hospital Augsburg.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Psychological condition that would preclude informed consent
- Additional tumor treatment between acquisition of tumor tissue and trial inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of tumor mutations between tissue biopsy (TBx) and liquid biopsy (LBx) at diagnosis
Time frame: through study completion, an average of 3 years
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)
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
Concordance between TBx and LBx at disease progression with TBx as reference method based on PPA (positive percent agreement) and NPA (negative percent agreement)
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maximilian Schmutz, MD principal investigator
UH Augsburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Characteristics Disease and Metastatic Cancer, run by University Hospital Augsburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sommer Sebastian, MD (+49-821400 ext. 161027, sebastian.sommer@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of tumor mutations between tissue biopsy (TBx) and liquid biopsy (LBx) at diagnosis (time frame: through study completion, an average of 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.