NCT01345760

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 investigators examines the expression profiles of the microprocessor complex subunit DGCR8 and the RISC components TARBP1, TARBP2, argonaute-1, argonaute-2 and PACT in epithelial skin cancer and its premalignant stage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2008

Typical duration 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
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2011

Completed
Last Updated

October 16, 2012

Status Verified

October 1, 2012

Enrollment Period

2.6 years

First QC Date

April 29, 2011

Last Update Submit

October 15, 2012

Conditions

Keywords

Basal Cell CarcinomaSquamous Cell CarcinomaActinic KeratosismicroRNADicerDroshaRISCmicroprocessor complexArgonauteDGCR8TARBP

Study Arms (4)

Basal Cell Carcinoma

Squamous Cell Carcinoma

Actinic Keratosis

healthy non-lesional skin

Eligibility Criteria

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

Patients with epithelial skin cancer and pre-malignant stages

You may qualify if:

  • epithelial skin cancer

You may not qualify if:

  • other known previous malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Related Publications (1)

  • Sand M, Skrygan M, Georgas D, Arenz C, Gambichler T, Sand D, Altmeyer P, Bechara FG. Expression levels of the microRNA maturing microprocessor complex component DGCR8 and the RNA-induced silencing complex (RISC) components argonaute-1, argonaute-2, PACT, TARBP1, and TARBP2 in epithelial skin cancer. Mol Carcinog. 2012 Nov;51(11):916-22. doi: 10.1002/mc.20861. Epub 2011 Oct 24.

Biospecimen

Retention: SAMPLES WITH DNA

human skin

MeSH Terms

Conditions

Skin NeoplasmsCarcinoma, Basal CellCarcinoma, Squamous CellKeratosis, ActinicRhabdomyosarcoma, Embryonal, 2

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Basal CellNeoplasms, Squamous CellPrecancerous ConditionsKeratosis

Study Officials

  • Falk G Bechara, PD Dr.

    Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 29, 2011

First Posted

May 2, 2011

Study Start

July 1, 2008

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

October 16, 2012

Record last verified: 2012-10

Locations