The Identification of Novel Prognostic Markers in Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01002560
First received: October 26, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 26, 2009
October 26, 2009
December 2008
December 2009   (final data collection date for primary outcome measure)
Given that the nature of the research is qualitative, there is no primary outcome measure. [ Designated as safety issue: No ]
Same as current
No Changes Posted
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The Identification of Novel Prognostic Markers in Melanoma
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.

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?

Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Non-Probability Sample

Group of subjects with malignant melanoma, who have been treated at the Royal Marsden Hospital

Malignant Melanoma
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact: Professor Martin Gore 02078082198 martin.gore@rmh.nhs.uk
United Kingdom
 
NCT01002560
CCR3078
No
Professor Martin Gore, Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
Not Provided
Principal Investigator: Professor Martin Gore Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP