Next-Generation-SequencingCIRCULATING-01NCT05871593
CIRculating Cell-free nUcLeic Acids in Cancer Therapy Monitoring -01
A study testing Molecular genetic diagnostic in people with Next-Generation-Sequencing, run by University Hospital Tuebingen.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Next-Generation-Sequencing
- What is being tested?
- Molecular genetic diagnostic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- No therapy recommendation by MTB
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Next-Generation-Sequencing
- Being tested
- Molecular genetic diagnostic
- Keywords
- Next-Generation-Sequencing, Cell free DNA, Cell free RNA, Circulating tumor DNA, Circulating tumor RNA, Course of therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular genetic diagnosticGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| Molecular genetic diagnostic | Other | Next-Generation-Sequencing (NGS)-methods Receives: Genetic: Molecular genetic diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
cfDNA/cfRNA
Ratio of cfDNA/cfRNA preoperative
Measured: Day 1: Preoperative
cfDNA/cfRNA
Ratio of cfDNA/cfRNA during therapy
Measured: Day 2: At intervals of approx. 6-10 weeks
cfDNA/cfRNA
Ratio of cfDNA/cfRNA at recurrence or disease progression
Measured: Day 3: Tumor recurrence or disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Next-Generation-SequencingStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- German Consortium for Translational Cancer Research
- Responsible party
- Sponsor
- Investigators
- Christopher Schroeder, Dr., Principal investigator, University Hospital TuebingenStephan Ossowski, Prof. Dr., Study chair, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871593
- Sponsor's protocol ID
- CIRCULATING-01
- Acronym
- CIRCULATING-01
- Status last verified
- May 2023
- First submitted
- 12 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The CIRCULATION-01 study will provide data in a pseudonymized manner to national and international databases set up to increase the diagnostic yield through advanced analysis tools.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIRculating Cell-free nUcLeic Acids in Cancer Therapy Monitoring -01
- ClinicalTrials.gov ID
- NCT05871593
- Acronym / sponsor ID
- CIRCULATING-01 / CIRCULATING-01
- Conditions
- Next-Generation-Sequencing
- Keywords
- Next-Generation-Sequencing, Cell free DNA, Cell free RNA, Circulating tumor DNA, Circulating tumor RNA, Course of therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- German Consortium for Translational Cancer Research
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Molecular genetic diagnostic | Other | Genetic: Molecular genetic diagnosticNext-Generation-Sequencing (NGS)-methods |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- No therapy recommendation by MTB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular genetic diagnosticWith 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. | Genetic | Molecular genetic diagnostic |
Primary outcome
cfDNA/cfRNA
Time frame: Day 1: Preoperative
Ratio of cfDNA/cfRNA preoperative
cfDNA/cfRNA
Time frame: Day 2: At intervals of approx. 6-10 weeks
Ratio of cfDNA/cfRNA during therapy
cfDNA/cfRNA
Time frame: Day 3: Tumor recurrence or disease progression
Ratio of cfDNA/cfRNA at recurrence or disease progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: Yes. The CIRCULATION-01 study will provide data in a pseudonymized manner to national and international databases set up to increase the diagnostic yield through advanced analysis tools.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Schroeder, Dr. principal investigator
University Hospital Tuebingen
Stephan Ossowski, Prof. Dr. study chair
University Hospital Tuebingen
Questions about this trial
What is this clinical trial studying?
A study testing Molecular genetic diagnostic in people with Next-Generation-Sequencing, run by University Hospital Tuebingen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher Schroeder, Dr. (+49 7071 29 ext. 72296, christopher.schroeder@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cfDNA/cfRNA (time frame: Day 1: Preoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.