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

NCT01482520 | Completed

• 1 other identifier: 2008-06-050
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma; Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Renal cell carcinoma

Hepatocellular carcinoma patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 30, 2011
• Study Start: August 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

KR (1)