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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00900536
First received: May 9, 2009
Last updated: August 9, 2013
Last verified: November 2008
  Purpose

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 Intervention
Kidney Cancer
Genetic: mutation analysis
Genetic: polymorphism analysis
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: TRANSORCE (A Sub-study of SORCE)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Relationship between tumor genotype, expression, and patient outcome [ Designated as safety issue: No ]
  • Relationship between constitutional genotype and patient outcome [ Designated as safety issue: No ]

Study Start Date: July 2007
Study Completion Date: June 2012
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed resected renal cell carcinoma

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900536

Locations
United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Sponsors and Collaborators
Medical Research Council
Investigators
Study Chair: Timothy Eisen Cancer Research UK at Cambridge Research Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00900536     History of Changes
Other Study ID Numbers: MRC-RE05-TRANSORCE, CDR0000601175, EU-20867, EUDRACT-2006-006079-19, ISRCTN38934710
Study First Received: May 9, 2009
Last Updated: August 9, 2013
Health Authority: Unspecified

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:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014