Malignant MelanomaNCT01002560
The Identification of Novel Prognostic Markers in Melanoma
An observational study of Malignant Melanoma, 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 malignant melanoma, 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
- Malignant Melanoma
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2008to Dec 2009
- 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: Group of subjects with malignant melanoma, who have been treated at the Royal Marsden Hospital
Who may be able to join
- Diagnosis of melanoma
- Adequate paraffin-embedded material available for analysis.
- Adequate clinical follow-up information
- Written informed consent where applicable
Who cannot join
- Inadequate paraffin-embedded material available
- Inadequate clinical follow-up information.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: Novel Prognostic Markers in Melanoma: 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 malignant melanoma, who have been treated at the Royal Marsden Hospital.
Read the detailed description
Background - The Royal Marsden Hospital and the Institute of Cancer Research constitute the largest comprehensive cancer centre in Europe. In addition to an in-house drug development program, phase I - phase III clinical trials of novel anti-cancer agents are hosted. In order to investigate the optimal use of novel molecularly targeted agents, access to clinical tumour samples is needed in order to determine which particular cancer type expresses a molecular "signature" that may indicate potential therapeutic utility. Understanding such signatures should accelerate the registration of new drugs for routine cancer therapy; offering the potential of selecting those patients with tumour types most likely to benefit from therapy. Furthermore, new insights into disease biology may be gained.
Main research question/ objective - Are there features of primary melanoma or lymph node metastases that predict subsequent clinical outcome better than existing markers?
- Conditions
- Malignant Melanoma
- Keywords
- Melanoma, Novel Prognostic Markers
- Medical subject headings
- Melanoma
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 |
|---|---|---|
| Malignant melanoma tumour tissue | Not described | |
| Benign pigmented lesions & other skin cancers | Normal skin, benign melanocytic tumours, and skin cancers from lineages other than melanocytic, to be used as negative controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Given that the nature of the research is qualitative, there is no primary outcome measure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Professor Martin Gore, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002560
- Sponsor's protocol ID
- CCR3078
- Status last verified
- Oct 2009
- First submitted
- 26 Oct 2009
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Prognostic Markers in Melanoma: a Protocol for the Analysis of Paraffin-embedded Tumour Samples
- ClinicalTrials.gov ID
- NCT01002560
- Acronym / sponsor ID
- CCR3078
- Conditions
- Malignant Melanoma
- Keywords
- Melanoma, Novel Prognostic Markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 27 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 malignant melanoma, who have been treated at the Royal Marsden Hospital.
Detailed description
Background - The Royal Marsden Hospital and the Institute of Cancer Research constitute the largest comprehensive cancer centre in Europe. In addition to an in-house drug development program, phase I - phase III clinical trials of novel anti-cancer agents are hosted. In order to investigate the optimal use of novel molecularly targeted agents, access to clinical tumour samples is needed in order to determine which particular cancer type expresses a molecular "signature" that may indicate potential therapeutic utility. Understanding such signatures should accelerate the registration of new drugs for routine cancer therapy; offering the potential of selecting those patients with tumour types most likely to benefit from therapy. Furthermore, new insights into disease biology may be gained.
Main research question/ objective - Are there features of primary melanoma or lymph node metastases that predict subsequent clinical outcome better than existing markers?
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malignant melanoma tumour tissue | – | – |
| Benign pigmented lesions & other skin cancers | – | –Normal skin, benign melanocytic tumours, and skin cancers from lineages other than melanocytic, to be used as negative controls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Group of subjects with malignant melanoma, who have been treated at the Royal Marsden Hospital
Key inclusion criteria (4 listed)
- Diagnosis of melanoma
- Adequate paraffin-embedded material available for analysis.
- Adequate clinical follow-up information
- Written informed consent where applicable
Key exclusion criteria (2 listed)
- Inadequate paraffin-embedded material available
- Inadequate clinical follow-up information.
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
Given that the nature of the research is qualitative, there is no primary outcome measure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2009.
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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 Malignant Melanoma, 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 4 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: status not confirmed, as of the sponsor's last update on 27 Oct 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Professor Martin Gore (02078082198, martin.gore@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Given that the nature of the research is qualitative, there is no primary outcome measure.. 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 27 Oct 2009.