Confocal Microscopy of Benign and Malignant Skin Tumors | NCT01010321

Studies
Confocal Microscopy of Benign and Malignant Skin Tumors

NCT01010321

Sponsor

Sheba Medical Center

Status

Suspended

Last Update Posted

Jun 29, 2010Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Skin Cancer

Interventions

confocal microscopy

Countries

Not provided

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

Jun 2010

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Nov 2010Estimated

Completion Date

Nov 2010Estimated

First Submitted Date

Nov 2, 2009

First Submission Date that Met QC Criteria

Nov 8, 2009

First Posted Date

Nov 10, 2009Estimated

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

Jun 27, 2010

Last Update Posted Date

Jun 29, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The investigators speculate that this tool may be used as an alternative and convenient non-invasive diagnostic of skin cancer.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
all study Population		all	Device: confocal microscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
confocal microscopy	Device	non-invasive imaging	all study Population

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
efficacy of a confocal microscope as a diagnostic tool		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women over the age of 18
Skin lesion suspected to either BCC or SCC etc
Patient was referred for biopsy diagnostic/therapeutic before hand, and regardless of confocal microscope examination, according to the clinical consideration of physician

Exclusion Criteria:

Pregnant women
Children

Accepts Healthy Volunteers

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

Men and women over the age of 18

- Skin lesion suspected to either BCC,SCC etc

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aviv Barzilai, Dr.	Sheba Medical Center	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012878	Skin Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018613	Microscopy, Confocal

Ancestor Terms

ID	Term
D008853	Microscopy
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided