Investigation of Human Alpha-fetoprotein Genes | NCT01258894

Studies
Investigation of Human Alpha-fetoprotein Genes

NCT01258894

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Dec 22, 2010Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Elevated or Normal Alpha-fetoprotein Patients

Interventions

Not provided

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

Dec 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Oct 2013Estimated

Completion Date

Oct 2013Estimated

First Submitted Date

Nov 30, 2010

First Submission Date that Met QC Criteria

Dec 10, 2010

First Posted Date

Dec 13, 2010Estimated

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

Dec 21, 2010

Last Update Posted Date

Dec 22, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Studies revealed that patients with hereditary persistence of AFP also had persistent abnormal AFP. Therefore, this study will recruit the patients and their family with elevated AFP (>20 ng/mL) and normal AFP patients being control groups. Then, their AFP genes extracted from the blood will be analyzed.

Detailed Description

Abnormal AFP elevation was usually noted in liver regeneration, HCC, nonseminomatous germ cell tumors or other malignant tumors. However, some studies revealed that patients with hereditary persistence of AFP also had persistent abnormal AFP. Therefore, we study will recruit the patients and their family with elevated AFP (>20 ng/mL) and normal AFP patients being control groups. Then, their AFP genes extracted from the blood will be analyzed. The hypothesis of this study is that the mutation of AFP gene might be one of the causes of abnormal AFP.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients and their family with elevated AFP (>20 ng/mL) and normal AFP patients being control groups. More than 20 years old

Exclusion Criteria:

Pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The patients and their family with elevated AFP (>20 ng/mL) and normal AFP patients being control groups.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jin Chuan Sheu, M.D. Ph.D.	Contact		66579	celian0916@yahoo.com.tw

Overall Officials

Name	Affiliation	Role
Jin Chuan Sheu, M.D. Ph.D.	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan