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

NCT05245136 | Unknown

• 1 other identifier: N67
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Characteristics Disease; Metastatic Cancer; Solid Tumor

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Investigation of tumor heterogeneity as a prognostic marker

  through study completion, an average of 3 years

• 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 in LBx with OS

  through study completion, an average of 3 years

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population consists of patients with diagnosis of metastatic cancer at the University Hospital Augsburg.

You may qualify if:

• 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

You may not qualify if:

• Psychological condition that would preclude informed consent

Sponsors & Collaborators

• University Hospital Augsburg: lead

Study Sites (1)

University Hospital Augsburg

Augsburg, Bavaria, 86156, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples retained, with potential for extraction of DNA from at least one of the types of samples retained (FFPE-tissue, whole blood, plasma)

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maximilian Schmutz, MD

  UH Augsburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sommer Sebastian, MD

CONTACT

+49-821400; sebastian.sommer@uk-augsburg.de

Rainer Claus, MD

CONTACT

+49-821400; rainer.claus@uk-augsburg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: February 17, 2022
• Study Start: March 29, 2021
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)