Back to resultsDNA Analysis of Blood and/or Tissue Samples From Patients With Primary Kidney Cancer Receiving Sorafenib on Clinical Trial MRC-RE05-SORCE
Primary Purpose
Kidney Cancer
Status
Completed
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
mutation analysis
polymorphism analysis
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
Sponsored by
About this trial
This is an observational trial for Kidney Cancer focused on measuring 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
Eligibility 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
Sites / Locations
- Addenbrooke's Hospital
Outcomes
Primary Outcome Measures
Relationship between tumor genotype, expression, and patient outcome
Relationship between constitutional genotype and patient outcome
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00900536
Brief Title
DNA Analysis of Blood and/or Tissue Samples From Patients With Primary Kidney Cancer Receiving Sorafenib on Clinical Trial MRC-RE05-SORCE
Official Title
TRANSORCE (A Sub-study of SORCE)
Study Type
Observational
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical Research Council
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
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
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
mutation analysis
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Type
Genetic
Intervention Name(s)
protein expression analysis
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Relationship between tumor genotype, expression, and patient outcome
Title
Relationship between constitutional genotype and patient outcome
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Eisen
Organizational Affiliation
Cancer Research UK
Official's Role
Study Chair
Facility Information:
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
DNA Analysis of Blood and/or Tissue Samples From Patients With Primary Kidney Cancer Receiving Sorafenib on Clinical Trial MRC-RE05-SORCE
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