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

University Hospital Augsburg

Status: Enrolling

Conditions: Solid Tumor; Metastatic Cancer; Characteristics Disease

Study type: Observational

Funder types: Other

Identifiers

NCT05245136

N67

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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