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NCT01482520 Clinical Trial

Genome-wide Association Study to Predict Treatment Response for Molecular Targeted Therapy in Hepatocellular Carcinoma and Renal Cell Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:
Genome-wide Association Study to Predict Treatment Response for Molecular Targeted Therapy in Hepatocellular Carcinoma and Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01482520
Other study ID # 2008-06-050
Secondary ID
Status Completed
Phase N/A
First received November 14, 2011
Last updated May 12, 2014
Start date August 2008
Est. completion date October 2013

Study information
Verified date May 2014
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study.

No additional treatment or intervention will be conducted except for blood sampling that will be limited to one time only.

Blood samples (10 cc in volume) will be collected from all study participants once they provided written informed consent form. DNA will be extracted from peripheral blood samples using DNA isolation kit.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date October 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Genotypes To define genotypes of HCC and RCC patients who will likely to response to molecular targeted therapy.
To define genotypes associated with adverse events from molecular targeted.
To identify genotypes which will predict survival or disease-free survival following molecular targeted therapy.		 36months No
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