CIRculating Cell-free nUcLeic Acids in Cancer Therapy Monitoring -01
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Molecular genetic diagnostic.
- Who it may be relevant to
- Registry conditions: Next-Generation-Sequencing. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
In this study, we would like to use and further develop Highly Sensitive Next-Generation Sequencing (NGS) methods. For this purpose, circulating cell-free nucleic acids (cell free desoxyribonucleic acid (cfDNA) or cell free ribonucleic acid (cfRNA)) are first isolated from the blood plasma. The circulating tumor desoxyribonucleic acid (ctDNA) and circulating tumor ribonucleic acid (ctRNA) fractions contained therein arise from the tumor tissue and can provide information about the existing tumor burden and the original tissue of the tumor. Somatic Single Nucleotide Variants (SNVs) and insertions and deletions (indels) serve as biomarkers within the ctDNA and ctRNA. The ctDNA also contains epigenetic information in the form of DNA methylation, which shows a characteristic pattern for each tissue. Informative regions of the genome can be specifically enriched using personalized or fixed NGS panels. In this way, an ultra-deep sequencing of defined regions can be carried out and even the smallest concentrations of ctDNA and ctRNA in liquid biopsies can be detected.
Interventions
- Genetic Molecular genetic diagnostic
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 t
Primary outcome measures
- cfDNA/cfRNA [Time frame: Day 1: Preoperative]
- cfDNA/cfRNA [Time frame: Day 2: At intervals of approx. 6-10 weeks]
- cfDNA/cfRNA [Time frame: Day 3: Tumor recurrence or disease progression]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
\- No therapy recommendation by MTB
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05871593 · CIRCULATING-01