Expression Levels of RISC and Microprocessor Complex Comp... | NCT01345760

Studies
Expression Levels of RISC and Microprocessor Complex Components in Epithelial Skin Cancer

NCT01345760

Sponsor

Ruhr University of Bochum

Status

Completed

Last Update Posted

Oct 16, 2012Estimated

Enrollment

44Actual

Phase

Not provided

Conditions

Skin Cancer

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Apr 29, 2011

First Submission Date that Met QC Criteria

Apr 29, 2011

First Posted Date

May 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2012

Last Update Posted Date

Oct 16, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Patients with premalignant actinic keratoses, basal cell carcinomas and squamous cell carcinomas were included in the study. Punch biopsies were harvested from the center of the tumors, from sites of healthy skin and a healthy control group. DGCR8, TARBP1, TARBP2, argonaute-1, argonaute-2 and PACT mRNA expression levels were detected by quantitative real-time reverse transcriptase polymerase chain reaction.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

44Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

epithelial skin cancer

Exclusion Criteria:

other known previous malignancies

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with epithelial skin cancer and pre-malignant stages

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Falk G Bechara, PD Dr.	Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum		Bochum	North Rhine-Westphalia	44791	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22025453	Result	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.

Label	Type	Description	Intervention Names
Basal Cell Carcinoma
Squamous Cell Carcinoma
Actinic Keratosis
healthy non-lesional skin

ID	Term
D012878	Skin Neoplasms
D002280	Carcinoma, Basal Cell
D002294	Carcinoma, Squamous Cell
D055623	Keratosis, Actinic
C566709	Rhabdomyosarcoma, Embryonal, 2

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases