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

NCT ID: NCT05245136

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-29

Study Completion Date

2025-04-30

Brief Summary

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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

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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

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Characteristics Disease Metastatic Cancer Solid Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Augsburg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maximilian Schmutz, MD

Role: PRINCIPAL_INVESTIGATOR

UH Augsburg

Locations

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University Hospital Augsburg

Augsburg, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Sommer Sebastian, MD

Role: CONTACT

+49-821400 ext. 161027

Rainer Claus, MD

Role: CONTACT

+49-821400 ext. 3715

Other Identifiers

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N67

Identifier Type: -

Identifier Source: org_study_id

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