CIRculating Cell-free nUcLeic Acids in Cancer Therapy Monitoring -01

NCT05871593 | Not Yet Recruiting

• 1 other identifier: CIRCULATING-01
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

In cooperation with the molecular tumor board of the University Hospital Tübingen (UKT), a prospective collection of blood samples during the course of therapy is planned. It is a pilot study in which the technical feasibility of the approach (Highly Sensitive Next-Generation Sequencing (NGS) methods) initially should to be evaluated and further developed.

Conditions

Next-Generation-Sequencing

Keywords

Next-Generation-Sequencing; Cell free DNA; Cell free RNA; Circulating tumor DNA; Circulating tumor RNA; Course of therapy

Outcome Measures

Primary Outcomes (3)

• cfDNA/cfRNA

  Ratio of cfDNA/cfRNA preoperative

  Day 1: Preoperative

• cfDNA/cfRNA

  Ratio of cfDNA/cfRNA during therapy

  Day 2: At intervals of approx. 6-10 weeks

• cfDNA/cfRNA

  Ratio of cfDNA/cfRNA at recurrence or disease progression

  Day 3: Tumor recurrence or disease progression

Study Arms (1)

Molecular genetic diagnostic

OTHER

Next-Generation-Sequencing (NGS)-methods

Genetic: Molecular genetic diagnostic

Interventions

Molecular genetic diagnostic GENETIC

With the help of modern, highly sensitive analysis methods (NGS), such as ultra-low high-throughput sequencing, even the smallest amounts of circulating cell-free nucleic acids in the blood can be detected. In the individual course of therapy, the changes in concentration of the tumor-specific variants can thus be continuously monitored and appropriate therapy decisions can be made. The presence of minimal residual diseases and the development of resistance mutations can also be examined using this technique.

Molecular genetic diagnostic

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Advanced tumor disease
• Ability to consent
• Existence of a declaration of consent signed by the patient and physician (informed consent for study participation and Comprehensive Cancer Center (CCC) biobank
• Existence or planned implementation of tumor-normal sequencing (usually carried out in a diagnostic context upon presentation at the Molecular Tumor Board (MTB)

You may not qualify if:

• \- No therapy recommendation by MTB

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• German Consortium for Translational Cancer Research: collaborator

Study Officials

• Christopher Schroeder, Dr.

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

• Stephan Ossowski, Prof. Dr.

  University Hospital Tübingen

  STUDY CHAIR

Central Study Contacts

Christopher Schroeder, Dr.

CONTACT

+49 7071 29; christopher.schroeder@med.uni-tuebingen.de

Julian Broche, Dr.

CONTACT

+49 7071 29; julian.broche@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 23, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Data will become available after analysis and unlimited.
• Access Criteria: Authorized users within the participating organizations.