DNA Analysis of Blood and/or Tissue Samples From Patients With Primary Kidney Cancer Receiving Sorafenib on Clinical Trial MRC-RE05-SORCE

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. Identifier: NCT00900536
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Studying samples of blood and/or tissue in the laboratory from patients with kidney cancer receiving sorafenib may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to sorafenib.

PURPOSE: This research study is looking at the DNA in blood and/or tissue samples from patients with primary kidney cancer receiving sorafenib on clinical trial MRC-RE05-SORCE.

Condition or disease Intervention/treatment
Kidney Cancer Genetic: mutation analysis Genetic: polymorphism analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis

Detailed Description:


  • Examine the relationship between tumor genotype, expression, and patient outcome.
  • Examine the relationship between constitutional genotype and patient outcome.

OUTLINE: This is a multicenter study.

Patients undergo blood and/or tissue sample collection for laboratory studies. Laboratory studies include generation of tissue microarrays; analysis of protein expression by immunohistochemistry; tumor DNA extraction and whole genome amplification; detection of VHL or other relevant gene mutations by direct sequencing; and constitutional (lymphocyte DNA) genotyping by single nucleotide polymorphism analysis.

Study Type : Observational
Official Title: TRANSORCE (A Sub-study of SORCE)
Study Start Date : July 2007
Actual Study Completion Date : June 2012

Primary Outcome Measures :
  1. Relationship between tumor genotype, expression, and patient outcome
  2. Relationship between constitutional genotype and patient outcome

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed resected renal cell carcinoma

    • Clear cell or non-clear cell tumor
  • Receiving sorafenib tosylate on clinical trial MRC-RE05-SORCE


  • Not specified


  • See Disease Characteristics

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 identifier (NCT number): NCT00900536

United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Sponsors and Collaborators
Medical Research Council
Study Chair: Timothy Eisen Cancer Research UK Identifier: NCT00900536     History of Changes
Other Study ID Numbers: MRC-RE05-TRANSORCE
CDR0000601175 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: November 2008

Keywords provided by National Cancer Institute (NCI):
clear cell renal cell carcinoma
stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer
papillary renal cell carcinoma

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