CIRculating Cell-free nUcLeic Acids in Cancer Therapy Monitoring -01
ConditionNext-Generation-Sequencing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Tuebingen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Molecular genetic diagnostic
GeneticWith 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Molecular genetic diagnosticOther 1 intervention
Trial outcomes
Primary outcomes
1
cfDNA/cfRNA
Ratio of cfDNA/cfRNA preoperative
Time frame
Day 1: Preoperative2
cfDNA/cfRNA
Ratio of cfDNA/cfRNA during therapy
Time frame
Day 2: At intervals of approx. 6-10 weeks3
cfDNA/cfRNA
Ratio of cfDNA/cfRNA at recurrence or disease progression
Time frame
Day 3: Tumor recurrence or disease progressionLocations
Sponsors and contacts
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University Hospital Tuebingen
Lead sponsor
German Consortium for Translational Cancer Research
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: