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Comparative Microarray Analysis in Primary Cutaneous Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Sand, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01482260
First received: November 26, 2011
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  Purpose

Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous malignant melanoma (CMM). This study will be an exploratory analysis by miRNA expression profiling using microarrays.


Condition Intervention
Cutaneous Malignant Melanoma
 Procedure: Biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Microarray Analysis of microRNA Expression Profiles in Primary Cutaneous Malignant Melanoma, Cutaneous Malignant Melanoma Metastases and Benign Melanocytic Naevi

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ruhr University of Bochum:

Biospecimen Retention:   Samples With DNA

skin biopsy


Enrollment: 21
Study Start Date: December 2011
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Primary Cutaneous Malignant Melanoma Procedure: Biopsy
Biopsy
Other Name: n.a.
Cutaneous Malignant Melanoma Metastases Procedure: Biopsy
Biopsy
Other Name: n.a.
Benign Melanocytic Nevi Procedure: Biopsy
Biopsy
Other Name: n.a.

Detailed Description:

Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous malignant melanoma (CMM). With regards to a rapidly growing number of newly discovered miRNA sequences, the availability of up-to-date miRNA expression profiles for primary cutaneous malignant melanoma (PCMM), cutaneous malignant melanoma metastases (CMMM) and benign melanocytic naevi (BMN) is limited. Patients with PCMM, CMMM and BMN are included in the study to perform an exploratory analysis by miRNA expression profiling using microarrays. Expression levels of miRNA candidates will be validated by TaqMan real-time quantitative polymerase chain reaction (RT-PCR).

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with

  • Primary Cutaneous Malignant Melanoma
  • Cutaneous Malignant Melanoma Metastases
  • Benign Melanocytic Naevi
Criteria

Inclusion Criteria:

  • Primary Cutaneous Malignant Melanoma
  • Cutaneous Malignant Melanoma Metastases
  • Benign Melanocytic Naevi

Exclusion Criteria:

- Other Skin Cancer than Primary Cutaneous Malignant Melanoma

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482260

Locations
Germany
Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
Bochum, NRW, Germany, 44791
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Study Director: Falk G Bechara, PD Dr. Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
Study Chair: Peter Altmeyer, Prof. Dr. Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
  More Information

Publications:

Responsible Party: Michael Sand, Principal Investigator, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01482260     History of Changes
Other Study ID Numbers: microRNA5
Study First Received: November 26, 2011
Last Updated: November 5, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 16, 2013