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

Solid Tumor Clinical Trial

— ALPS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05245136
• Other study ID #: N67
• Status: Recruiting
• Start date: March 29, 2021
• Est. completion date: April 2025

Study information

• Verified date: November 2023
• Source: University Hospital Augsburg
• Contact: Sommer Sebastian, MD
• Phone: +49-821400
• Email: sebastian.sommer[@]uk-augsburg.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Characteristics Disease
• Metastatic Cancer
• Neoplasm Metastasis
• Solid Tumor

Locations

Country	Name	City	State
Germany	University Hospital Augsburg	Augsburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Augsburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	through study completion, an average of 3 years
Primary	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)	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	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	through study completion, an average of 3 years
Secondary	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	through study completion, an average of 3 years
Secondary	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	through study completion, an average of 3 years
Secondary	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	through study completion, an average of 3 years