Renal Cell CarcinomaNCT01002937
Novel Prognostic Markers in Renal Cancer
An observational study of Renal Cell Carcinoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Cell Carcinoma
- How many people
- 182 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2008to 17 Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Tumour tissue from subjects with renal cell carcinoma, who have been treated at the Royal Marsden Hospital
Who may be able to join
- 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)
Who cannot join
- Absence of histological tissue
- Absence of consent to study tissue after January 2006
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: Novel Prognostic Markers in Renal Cancer: a Protocol for the Analysis of Paraffin Embedded Tumour Samples
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.
Read the 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.
- Conditions
- Renal Cell Carcinoma
- Keywords
- Biomarkers, Prognosis response to treatment, Renal cancer
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tumour tissue, renal cell carcinoma | > 2mm x 2mm of tumour tissue obtained from paraffin blocks taken from biopsies or nephrectomy specimens. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study start1 Dec 2008
- Primary completion17 Dec 2014
- Study completion17 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RMH R&D, Royal Marsden NHS Foundation Trust
- Investigators
- Professor Martin Gore, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002937
- Sponsor's protocol ID
- CCR3076
- Status last verified
- Jun 2024
- First submitted
- 27 Oct 2009
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Prognostic Markers in Renal Cancer: a Protocol for the Analysis of Paraffin Embedded Tumour Samples
- ClinicalTrials.gov ID
- NCT01002937
- Acronym / sponsor ID
- CCR3076
- Conditions
- Renal Cell Carcinoma
- Keywords
- Biomarkers, Prognosis response to treatment, Renal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Dec 2008 (actual)
- Primary completion
- 17 Dec 2014 (actual)
- Study completion
- 17 Dec 2014 (actual)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumour tissue, renal cell carcinoma | – | –> 2mm x 2mm of tumour tissue obtained from paraffin blocks taken from biopsies or nephrectomy specimens. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Tumour tissue from subjects with renal cell carcinoma, who have been treated at the Royal Marsden Hospital
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Absence of histological tissue
- Absence of consent to study tissue after January 2006
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
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Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Martin Gore principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.