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NCT Number: NCT00900536

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

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.

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Key information

Conditions

Kidney Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mutation analysis

Genetic

polymorphism analysis

Genetic

protein expression analysis

Genetic

immunohistochemistry staining method

Other

laboratory biomarker analysis

Other

Primary outcomes

  1. Relationship between tumor genotype, expression, and patient outcome

  2. Relationship between constitutional genotype and patient outcome

Sponsors and collaborators

Lead sponsor

Medical Research Council

Other Gov

Registry information

Official study title

TRANSORCE (A Sub-study of SORCE)

Important dates

Study start
2007
Study completion
2012
First posted
May 12, 2009
Registry last updated
Aug 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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