NCT00862914

Brief Summary

MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length, capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of complementarity. miRNAs have recently been shown to play pivotal roles in diverse developmental and cellular processes and linked to a variety of skin diseases and cancers. In the present study the researchers investigate the immunohistochemical distribution of Dicer in benign and dysplastic melanocytic naevi as well as in cutaneous malignant melanoma compared to intraindividual healthy control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
Last Updated

October 16, 2012

Status Verified

October 1, 2012

Enrollment Period

7 months

First QC Date

March 16, 2009

Last Update Submit

October 15, 2012

Conditions

Keywords

SkinMicroRNAmiRNADicerMalignant Melanoma

Study Arms (3)

1

benign melanocytic naevi

2

dysplastic melanocytic naevi

3

cutaneous malignant melanoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

dermatologic primary care clinic

You may qualify if:

  • Patients with benign melanocytic naevi, dysplastic melanocytic naevi and cutaneous malignant melanoma.

You may not qualify if:

  • Patients under 18 years of age
  • Patients with other forms of cancer in previous medical history
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology and Allergology, Ruhr-University Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Related Publications (1)

  • Sand M, Gambichler T, Sand D, Altmeyer P, Stuecker M, Bechara FG. Immunohistochemical expression patterns of the microRNA-processing enzyme Dicer in cutaneous malignant melanomas, benign melanocytic nevi and dysplastic melanocytic nevi. Eur J Dermatol. 2011 Jan-Feb;21(1):18-21. doi: 10.1684/ejd.2011.1210.

Biospecimen

Retention: SAMPLES WITH DNA

Paraffin embedded melanocytic skin lesion

MeSH Terms

Conditions

NevusMelanomaRhabdomyosarcoma, Embryonal, 2

Condition Hierarchy (Ancestors)

Nevi and MelanomasNeoplasms by Histologic TypeNeoplasmsNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Prof. Dr. Peter Altmeyer

    Department of Dermatology and Allergology, Ruhr-University Bochum

    PRINCIPAL INVESTIGATOR
  • PD Dr. Falk G. Bechara

    Department of Dermatology and Allergology, Ruhr-University Bochum

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 17, 2009

Study Start

July 1, 2008

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

October 16, 2012

Record last verified: 2012-10

Locations