Comparative Microarray Analysis in Primary Cutaneous Mali... | NCT01482260

Studies
Comparative Microarray Analysis in Primary Cutaneous Malignant Melanoma

NCT01482260

Sponsor

Ruhr University of Bochum

Status

Completed

Last Update Posted

Nov 6, 2012Estimated

Enrollment

21Actual

Phase

Not provided

Conditions

Cutaneous Malignant Melanoma

Interventions

Biopsy

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

Nov 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

Dec 2011

Primary Completion Date

Jan 2012Actual

Completion Date

Not provided

First Submitted Date

Nov 26, 2011

First Submission Date that Met QC Criteria

Nov 29, 2011

First Posted Date

Nov 30, 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

Nov 5, 2012

Last Update Posted Date

Nov 6, 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

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.

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).

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

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Primary Cutaneous Malignant Melanoma			Procedure: Biopsy
Cutaneous Malignant Melanoma Metastases			Procedure: Biopsy
Benign Melanocytic Nevi			Procedure: Biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biopsy	Procedure	Biopsy	Benign Melanocytic Nevi Cutaneous Malignant Melanoma Metastases Primary Cutaneous Malignant Melanoma

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary Cutaneous Malignant Melanoma
Cutaneous Malignant Melanoma Metastases
Benign Melanocytic Naevi

Exclusion Criteria:

- Other Skin Cancer than Primary Cutaneous Malignant Melanoma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with

Primary Cutaneous Malignant Melanoma
Cutaneous Malignant Melanoma Metastases
Benign Melanocytic Naevi

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
Peter Altmeyer, Prof. Dr.	Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum	Study Chair

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
23111773	Result	Sand M, Skrygan M, Sand D, Georgas D, Gambichler T, Hahn SA, Altmeyer P, Bechara FG. Comparative microarray analysis of microRNA expression profiles in primary cutaneous malignant melanoma, cutaneous malignant melanoma metastases, and benign melanocytic nevi. Cell Tissue Res. 2013 Jan;351(1):85-98. doi: 10.1007/s00441-012-1514-5. Epub 2012 Oct 31.

ID	Term
D008545	Melanoma
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal

ID	Term
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures