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NCT Number: NCT05871593

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. cfDNA/cfRNA

    Time frame: Day 1: Preoperative

    Ratio of cfDNA/cfRNA preoperative

  2. cfDNA/cfRNA

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

    Ratio of cfDNA/cfRNA during therapy

  3. cfDNA/cfRNA

    Time frame: Day 3: Tumor recurrence or disease progression

    Ratio of cfDNA/cfRNA at recurrence or disease progression

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Schroeder, Dr.

CONTACT

[email protected]

+49 7071 29 ext. 72296

Julian Broche, Dr.

CONTACT

[email protected]

+49 7071 29 ext. 61298

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • German Consortium for Translational Cancer Research

Registry information

Acronym: CIRCULATING-01

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 23, 2023
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.