Clinical trial NCT05871593: CIRculating Cell-free nUcLeic Acids in Cancer Therapy Monitoring -01
Official title: CIRculating Cell-free nUcLeic Acids in Cancer Therapy Monitoring -01
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Next-Generation-Sequencing
Keywords: Next-Generation-Sequencing
Cell free DNA
Cell free RNA
Circulating tumor DNA
Circulating tumor RNA
Course of therapy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: German Consortium for Translational Cancer Research
First posted: 2023-05-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

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

Primary outcomes:
measure: cfDNA/cfRNA
timeFrame: Day 1: Preoperative
measure: cfDNA/cfRNA
timeFrame: Day 2: At intervals of approx. 6-10 weeks
measure: cfDNA/cfRNA
timeFrame: Day 3: Tumor recurrence or disease progression
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Tübingen
name: Christopher Schroeder, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Tübingen
name: Stephan Ossowski, Prof. Dr.
role: STUDY_CHAIR
References: