OPTImisation and Standardization of CIRCulating Cell-free... | NCT06869070

Studies
OPTImisation and Standardization of CIRCulating Cell-free DNA Ex-traction Protocols in a Diagnostic Setting

NCT06869070

Sponsor

University Hospital Tuebingen

Status

Not yet recruiting

Last Update Posted

Mar 11, 2025Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 7, 2025Estimated

Primary Completion Date

May 2025Estimated

Completion Date

Aug 2025Estimated

First Submitted Date

Feb 7, 2025

First Submission Date that Met QC Criteria

Mar 6, 2025

First Posted Date

Mar 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2025

Last Update Posted Date

Mar 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cfDNA quantity	we will assess the quantities in ng/µl of cell-free DNA extracted from plasma	Baseline, at enrollment
cfDNA quality	we will assess the fragments length in nucleotides using TermoFisher's Tapestation from the extracted plasma cell-free DNA	Baseline, at enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Population has to be older than 18 years, can be of any gender and have a disease-free status

Sampling Method

Non-Probability Sample

Label	Type	Description	Intervention Names
Short term
Long term