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NCT Number: NCT05245136

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

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.

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Key information

Conditions

Characteristics Disease Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Augsburg

Augsburg, Bavaria, 86156, Germany

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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 with imaging modalities based on morphological therapeutic response: ORR in classical entities and pools of tumor entities with ≥ 40 patient sample size

  2. 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 with imaging modalities based on morphological therapeutic response: DCR in classical entities and pools of tumor entities with ≥ 40 patient sample size

  3. Correlation of known and potential oncogenic drivers in LBx with OS

    Time frame: through study completion, an average of 3 years

    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

  4. 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

    to evaluate the role of a single numeric value (Shannon-Heterogeneity Index) at diagnosis as a surrogate marker for tumor heterogeneity

Study contacts

Contact information is provided by the study sponsor or research team.

Rainer Claus, MD

CONTACT

[email protected]

+49-821400 ext. 3715

Sommer Sebastian, MD

CONTACT

[email protected]

+49-821400 ext. 161027

Sponsors and collaborators

Lead sponsor

University Hospital Augsburg

Other

Registry information

Official study 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

Acronym: ALPS

Important dates

Study start
2021
Primary completion
2029
Study completion
2030
First posted
Feb 17, 2022
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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