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

Kidney Cancer Clinical Trial

Official title:

TRANSORCE (A Sub-study of SORCE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900536
• Other study ID #: MRC-RE05-TRANSORCE
• Secondary ID: CDR0000601175EU-
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: August 9, 2013
• Start date: July 2007
• Est. completion date: June 2012

Study information

• Verified date: November 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Genetic:
• mutation analysis

• polymorphism analysis

• protein expression analysis

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge	England

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between tumor genotype, expression, and patient outcome			No
Primary	Relationship between constitutional genotype and patient outcome			No