NCT00849914

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 expression profiles for the two most important miRNA processing enzymes Dicer and Drosha of actinic keratoses, basal cell carcinoma and squamous cell carcinoma are compared to healthy skin tissue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

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
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
Last Updated

October 16, 2012

Status Verified

October 1, 2012

Enrollment Period

7 months

First QC Date

February 20, 2009

Last Update Submit

October 15, 2012

Conditions

Skin Cancer

Study Arms (3)

1

Patients with actinic keratoses of the skin

2

Patients with basal cell carcinoma of the skin

3

Patients with squamous cell carcinoma of the skin

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 actinic keratoses, squamous cell carcinoma or basal cell carcinoma of the skin

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology and Allergology, Ruhr-University Bochum

Bochum, 44791, Germany

Location

Related Publications (1)

  • Sand M, Gambichler T, Skrygan M, Sand D, Scola N, Altmeyer P, Bechara FG. Expression levels of the microRNA processing enzymes Drosha and dicer in epithelial skin cancer. Cancer Invest. 2010 Jul;28(6):649-53. doi: 10.3109/07357901003630918.

    PMID: 20210522RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Punch biopsy from tumour, punch biopsy from healthy skin

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Prof. Dr. Peter Altmeyer

    Department of Dermatology and Allergology, Ruhr-University Bochum

    PRINCIPAL INVESTIGATOR

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

February 20, 2009

First Posted

February 24, 2009

Study Start

July 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

October 16, 2012

Record last verified: 2012-10

Locations

DE(1)