HealthyOPTICIRCNCT06869070
OPTImisation and Standardization of CIRCulating Cell-free DNA Ex-traction Protocols in a Diagnostic Setting
An observational study of Healthy, run by University Hospital Tuebingen.
Trial summary
comparison of blood collection tubes and cell-free DNA extraction to evaluate the best possible combination to obtain high quantity and quality cell-free DNA sample for NGS analyses Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 7 Apr 2025to Aug 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Population has to be older than 18 years, can be of any gender and have a disease-free status
Who may be able to join
- at least 18 years
- no serious condition
Who cannot join
- younger than 18 years
- serious health condition that leads to higher cfDNA content in blood
About this study
Official title: Optimisation and Standardization of Circulating Cell-free DNA Ex-traction Protocols in a Diagnostic Setting
comparison of blood collection tubes and cell-free DNA extraction to evaluate the best possible combination to obtain high quantity and quality cell-free DNA sample for NGS analyses
- Conditions
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Short term | Not described | |
| Long term | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
cfDNA quantity
we will assess the quantities in ng/µl of cell-free DNA extracted from plasma
Measured: Baseline, at enrollment
cfDNA quality
we will assess the fragments length in nucleotides using TermoFisher's Tapestation from the extracted plasma cell-free DNA
Measured: Baseline, at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start7 Apr 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869070
- Sponsor's protocol ID
- OPTICIRC
- Acronym
- OPTICIRC
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation and Standardization of Circulating Cell-free DNA Ex-traction Protocols in a Diagnostic Setting
- ClinicalTrials.gov ID
- NCT06869070
- Acronym / sponsor ID
- OPTICIRC / OPTICIRC
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 7 Apr 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 11 Mar 2025 (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.
comparison of blood collection tubes and cell-free DNA extraction to evaluate the best possible combination to obtain high quantity and quality cell-free DNA sample for NGS analyses
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short term | – | – |
| Long term | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population has to be older than 18 years, can be of any gender and have a disease-free status
Key inclusion criteria (2 listed)
- at least 18 years
- no serious condition
Key exclusion criteria (2 listed)
- younger than 18 years
- serious health condition that leads to higher cfDNA content in blood
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cfDNA quantity
Time frame: Baseline, at enrollment
we will assess the quantities in ng/µl of cell-free DNA extracted from plasma
cfDNA quality
Time frame: Baseline, at enrollment
we will assess the fragments length in nucleotides using TermoFisher's Tapestation from the extracted plasma cell-free DNA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, 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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 11 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cfDNA quantity (time frame: Baseline, at enrollment). The study lists 2 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 11 Mar 2025.