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NCT05871593 | NOT YET RECRUITING | Next-Generation-Sequencing

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

University Hospital Tuebingen

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.

Condition or disease

Next-Generation-Sequencing

Intervention/treatment

Molecular genetic diagnostic

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : CIRculating Cell-free nUcLeic Acids in Cancer Therapy Monitoring -01
Actual Study Start Date : 2023-10
Estimated Primary Completion Date : 2025-10
Estimated Study Completion Date : 2026-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
CIRculating Cell-free nUcLeic Acids in Cancer Therapy Monitoring -01

Location Details

NCT05871593

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Locations

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