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

NCT ID: NCT00900536

Last Updated: 2013-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Kidney Cancer

Keywords

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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

Interventions

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mutation analysis

Intervention Type GENETIC

polymorphism analysis

Intervention Type GENETIC

protein expression analysis

Intervention Type GENETIC

immunohistochemistry staining method

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Research Council

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Timothy Eisen

Role: STUDY_CHAIR

Cancer Research UK

Locations

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Addenbrooke's Hospital

Cambridge, England, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CDR0000601175

Identifier Type: REGISTRY

Identifier Source: secondary_id

EU-20867

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2006-006079-19

Identifier Type: -

Identifier Source: secondary_id

ISRCTN38934710

Identifier Type: -

Identifier Source: secondary_id

MRC-RE05-TRANSORCE

Identifier Type: -

Identifier Source: org_study_id