Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital Augsburg (Other)
Overall Status
Recruiting
CT.gov ID
NCT05245136
Collaborator
(none)
3,000
Enrollment
1
Location
48.1
Anticipated Duration (Months)
62.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Mar 29, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2025
    Anticipated Study Completion Date :
    Apr 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Correlation of tumor mutations between tissue biopsy (TBx) and liquid biopsy (LBx) at diagnosis [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 [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 Outcome Measures

    1. Investigation of tumor heterogeneity as a prognostic marker [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 [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Augsburg Augsburg Bavaria Germany 86156

    Sponsors and Collaborators

    • University Hospital Augsburg

    Investigators

    • Principal Investigator: Maximilian Schmutz, MD, UH Augsburg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Augsburg
    ClinicalTrials.gov Identifier:
    NCT05245136
    Other Study ID Numbers:
    • N67
    First Posted:
    Feb 17, 2022
    Last Update Posted:
    Feb 17, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasm Metastasis

    Study Results

    No Results Posted as of Feb 17, 2022