Novel Prognostic Markers in Melanoma: a Protocol for the Analysis of Paraffin-embedded Tumour Samples
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Given that the nature of the research is qualitative, there is no primary outcome measure.
Study Overview
Brief 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.
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
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of melanoma
- •Adequate paraffin-embedded material available for analysis.
- •Adequate clinical follow-up information
- •Written informed consent where applicable
Exclusion Criteria
- •Inadequate paraffin-embedded material available
- •Inadequate clinical follow-up information.
Outcomes
Primary Outcomes
Given that the nature of the research is qualitative, there is no primary outcome measure.
Secondary Outcomes
No secondary outcomes reported