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Investigation of Human Alpha-fetoprotein Genes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01258894
First Posted: December 13, 2010
Last Update Posted: December 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
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.

Condition
Elevated or Normal Alpha-fetoprotein Patients

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Investigation of Human Alpha-fetoprotein Genes

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   Samples With DNA
10c.c Whole Blood

Estimated Enrollment: 300
Study Start Date: December 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The patients and their family with elevated AFP (>20 ng/mL) and normal AFP patients being control groups.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258894


Contacts
Contact: Jin Chuan Sheu, M.D. Ph.D. celian0916@yahoo.com.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jin-Chuan Sheu, M.D. Ph.D.    886-2-23123456 ext 66579    celian0916@yahoo.com.tw   
Principal Investigator: Jin-Chuan Sheu, M.D. Ph.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jin Chuan Sheu, M.D. Ph.D. National Taiwan University Hospital
  More Information

Responsible Party: Jin-Chuan Sheu/ M.D. Ph.D., National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01258894     History of Changes
Other Study ID Numbers: 201010019R
First Submitted: November 30, 2010
First Posted: December 13, 2010
Last Update Posted: December 22, 2010
Last Verified: December 2010