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The Identification of Novel Prognostic Markers in Melanoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01002560
First Posted: October 27, 2009
Last Update Posted: October 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Royal Marsden NHS Foundation Trust
  Purpose
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.

Condition
Malignant Melanoma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Novel Prognostic Markers in Melanoma: a Protocol for the Analysis of Paraffin-embedded Tumour Samples

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • Given that the nature of the research is qualitative, there is no primary outcome measure.

Estimated Enrollment: 500
Study Start Date: December 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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?

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Group of subjects with malignant melanoma, who have been treated at the Royal Marsden Hospital
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002560


Contacts
Contact: Professor Martin Gore 02078082198 martin.gore@rmh.nhs.uk

Locations
United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Professor Martin Gore Royal Marsden NHS Foundation Trust
  More Information

Responsible Party: Professor Martin Gore, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01002560     History of Changes
Other Study ID Numbers: CCR3078
First Submitted: October 26, 2009
First Posted: October 27, 2009
Last Update Posted: October 27, 2009
Last Verified: October 2009

Keywords provided by Royal Marsden NHS Foundation Trust:
Melanoma
Novel Prognostic Markers

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas


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