Molecular Characterization of Cutaneous Tumors | NCT03092830

Studies
Molecular Characterization of Cutaneous Tumors

NCT03092830

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Apr 30, 2019Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Squamous Cell Carcinoma
Basal Cell Carcinoma

Interventions

Molecular testing of DNA/RNA from skin tumors, SCC/BCC

Countries

Israel

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

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 29, 2017Actual

Primary Completion Date

Aug 7, 2020Estimated

Completion Date

Aug 7, 2020Estimated

First Submitted Date

Mar 22, 2017

First Submission Date that Met QC Criteria

Mar 27, 2017

First Posted Date

Mar 28, 2017Actual

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

Apr 28, 2019

Last Update Posted Date

Apr 30, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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 objective is to find genes which are responsible for the appearance of skin tumors (sCC, BCC) and it will be the basis for prediction of the disease and response to the treatment

Detailed Description

Prospective, 1-arm, 500 participates above 18 age with skin tumor affliction sCC and BCC type.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1-arm, 500 participates		Molecular testing of DNA/RNA from skin tumors, SCC/BCC	Genetic: Molecular testing of DNA/RNA from skin tumors, SCC/BCC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Molecular testing of DNA/RNA from skin tumors, SCC/BCC	Genetic	Molecular testing of DNA/RNA from skin tumors, SCC/BCC	1-arm, 500 participates

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Molecular Characterization of cutaneous tumors	samples from subjects	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient that have sCC and BCC tumors
above 18 years old

Exclusion Criteria:

below 18 years old
pregnant women
children or person without judgment ability

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

above 18 years old with Scc and BCC skin tumors not pregnant women and no children or any person without judgment ability

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
DR Dean Ad EL, MD	Contact	+972-3-9376366		deana@clalit.org.il
DR Asaf Olshinka, MD	Contact	+972-3-9376366

Overall Officials

Name	Affiliation	Role
DR Dean Ad EL, MD	Rabin Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RabinMC	Recruiting	Petah Tikva		49100	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28275910	Background	Winder M, Viros A. Mechanisms of Drug Resistance in Melanoma. Handb Exp Pharmacol. 2018;249:91-108. doi: 10.1007/164_2017_17.

ID	Term
D002294	Carcinoma, Squamous Cell
D002280	Carcinoma, Basal Cell

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms