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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
  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. [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Professor Martin Gore, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01002560     History of Changes
Other Study ID Numbers: CCR3078
Study First Received: October 26, 2009
Last Updated: October 26, 2009
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 20, 2014