OPTImisation and Standardization of CIRCulating Cell-free DNA Ex-traction Protocols in a Diagnostic Setting (OPTICIRC)
March 6, 2025 updated by: University Hospital Tuebingen
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
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
10
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Population has to be older than 18 years, can be of any gender and have a disease-free status
Description
Inclusion Criteria:
- at least 18 years
- no serious condition
Exclusion Criteria:
- younger than 18 years
- serious health condition that leads to higher cfDNA content in blood
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Short term
|
|
Long term
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cfDNA quantity
Time Frame: Baseline, at enrollment
|
we will assess the quantities in ng/µl of cell-free DNA extracted from plasma
|
Baseline, at enrollment
|
|
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
|
Baseline, at enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 7, 2025
Primary Completion (Estimated)
May 1, 2025
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
February 7, 2025
First Submitted That Met QC Criteria
March 6, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 6, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- OPTICIRC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.