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

This study is currently recruiting participants.
Verified November 2011 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Ho Yeong Lim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01482520
First received: November 14, 2011
Last updated: November 29, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition
Hepatocellular Carcinoma
Renal Cell Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Genome-wide Association Study to Predict Treatment Response for Molecular Targeted Therapy in Hepatocellular Carcinoma and Renal Cell Carcinoma

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Genotypes [ Time Frame: 36months ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 200
Study Start Date: August 2008
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Renal cell carcinoma
Hepatocellular carcinoma patients

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Once the patient signed written informed consent, two bottles of 5 cc blood will be drawn and subsequently extracted DNA and serum will be stored until genetic analysis.

Criteria

Inclusion Criteria:

  • All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482520

Contacts
Contact: mi yeon kwon, RN +82-2-3410-1248 miyeon.kwon@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: mi yeon kwon, RN     +82-2-3410-1248     miyeon.kwon@samsung.com    
Principal Investigator: Ho Yeong Lim, MD            
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Ho Yeong Lim, Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01482520     History of Changes
Other Study ID Numbers: 2008-06-050
Study First Received: November 14, 2011
Last Updated: November 29, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
 Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Liver Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on June 17, 2013