- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01258894
Investigation of Human Alpha-fetoprotein Genes
December 21, 2010 updated by: National Taiwan University Hospital
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.
Study Overview
Status
Unknown
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.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
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Contact:
- Jin-Chuan Sheu, M.D. Ph.D.
- Phone Number: 66579 886-2-23123456
- Email: celian0916@yahoo.com.tw
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Principal Investigator:
- Jin-Chuan Sheu, M.D. Ph.D.
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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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jin Chuan Sheu, M.D. Ph.D., National Taiwan University Hospital
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
December 1, 2010
Primary Completion (Anticipated)
October 1, 2013
Study Completion (Anticipated)
October 1, 2013
Study Registration Dates
First Submitted
November 30, 2010
First Submitted That Met QC Criteria
December 10, 2010
First Posted (Estimate)
December 13, 2010
Study Record Updates
Last Update Posted (Estimate)
December 22, 2010
Last Update Submitted That Met QC Criteria
December 21, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- 201010019R
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.
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