The Utility of Cell-free Methylation Markers in Blood for... | NCT05576571

Studies
The Utility of Cell-free Methylation Markers in Blood for Hepatocellular Carcinoma

NCT05576571

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Oct 17, 2022Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Serum Tumor Markers

Interventions

Met-score

Countries

Taiwan

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

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 16, 2020Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Oct 6, 2022

First Submission Date that Met QC Criteria

Oct 11, 2022

First Posted Date

Oct 12, 2022Actual

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

Oct 13, 2022

Last Update Posted Date

Oct 17, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients with liver cancer expected to undergo radiofrequency ablation or transvascular embolization. Relevant tumor markers (AFP and methylation analysis) were performed. The two data are then counted and compared.

Detailed Description

The subjects of this study were patients who were diagnosed with liver cancer by physicians based on AASLD clinical criteria or pathological biopsy.

Patients are those who received radiofrequency ablation or transvascular embolization in National Taiwan University Hospital. Which excludes weakness and inability to cooperate Patients with blood test, under the condition of fully informed consent, complete blood test related tumor indicators (AFP and methylation analysis). The two data are then counted Compare.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HCC case		Patients are those who received radiofrequency ablation or transvascular embolization in National Taiwan University Hospital. Which excludes weakness and inability to cooperate Patients with blood test, under the condition of fully informed consent, complete blood test related tumor indicators (AFP and methylation analysis). The two data are then counted Compare.	Diagnostic Test: Met-score

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Met-score	Diagnostic Test	methylation analysis	HCC case

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate efficacy (methylation profiling results)	Correlation of methylation profiling results with AFP and tumor treatment response.	3 month after treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with liver cancer by AASLD clinical criteria or pathological sections are planned to receive treatment at National Taiwan University Hospital Liver local treatment such as radiofrequency ablation or transvascular embolization.
Be over 20 years old.
Under the condition of informed consent, willing to sign the consent form of the subjects.

Exclusion Criteria:

Patients who are weak and unable to cooperate with blood test.
Kidney dysfunction, serum creatinine greater than 1.5mg/dl, it is judged that computer tomography or MRI cannot be performed Vibrate the injector.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with liver cancer by AASLD clinical criteria or pathological sections are planned to receive treatment at National Taiwan University Hospital Liver local treatment such as radiofrequency ablation or transvascular embolization.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kai-Wen Huang, MD, PhD	study principal investigator	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei			Taiwan