Novel Prognostic Markers in Renal Cancer | NCT01002937

Studies
Novel Prognostic Markers in Renal Cancer

NCT01002937

Sponsor

Royal Marsden NHS Foundation Trust

Status

Completed

Last Update Posted

Jun 18, 2024Actual

Enrollment

182Actual

Phase

Not provided

Conditions

Renal Cell Carcinoma

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2008Actual

Primary Completion Date

Dec 17, 2014Actual

Completion Date

Dec 17, 2014Actual

First Submitted Date

Oct 27, 2009

First Submission Date that Met QC Criteria

Oct 27, 2009

First Posted Date

Oct 28, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2024

Last Update Posted Date

Jun 18, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

RMH R&D, Professor Martin Gore, Royal Marsden NHS Foundation TrustPrincipal Investigator

Lead Sponsor

Royal Marsden NHS Foundation TrustOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this project is to analyze tumour tissue from a group of subjects with renal cell carcinoma, who have been treated at the Royal Marsden Hospital.

Detailed Description

Renal cancers have different clinical outcomes. The principal research objective is to study tumour tissue from renal cancer patients and try and understand why some cancers progress more rapidly than others. Further, another key aim of this study is to try and understand why some patients respond to treatment and others do not.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

182Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tumour tissue, renal cell carcinoma		> 2mm x 2mm of tumour tissue obtained from paraffin blocks taken from biopsies or nephrectomy specimens.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The profiling of the expression of signal transduction biomarkers, gene expression, gene copy numbers and effect of mutations of the VHL gene in renal cancer and their relationship to clinical outcomes.		5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The presence of histologically proven renal cell cancer
The availability of paraffin embedded tissue
Informed consent needed for tissue taken after January 2006 (date of enforcement of human tissue act)

Exclusion Criteria:

Absence of histological tissue
Absence of consent to study tissue after January 2006

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Tumour tissue from subjects with renal cell carcinoma, who have been treated at the Royal Marsden Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Professor Martin Gore	Royal Marsden NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Royal Marsden NHS Foundation Trust		Sutton	Surrey	SM2 5PT	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D002292	Carcinoma, Renal Cell
D007680	Kidney Neoplasms

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided