Epidemiology of Merkel Carcinomas in the Bas-Rhin | NCT03518307

Studies
Epidemiology of Merkel Carcinomas in the Bas-Rhin

NCT03518307

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

May 8, 2018Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Merkel Carcinoma

Interventions

Not provided

Countries

France

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 2018

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

Sep 1, 2017Actual

Primary Completion Date

Sep 2018Estimated

Completion Date

Sep 2018Estimated

First Submitted Date

Apr 25, 2018

First Submission Date that Met QC Criteria

Apr 25, 2018

First Posted Date

May 8, 2018Actual

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 25, 2018

Last Update Posted Date

May 8, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 aim of this work is to study demographic, clinical, management (diagnostic and therapeutic) and survival data concerning patients with Merkel's carcinoma in the Lower Rhine, thus obtaining the first French data.

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

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

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrospective study of demographic, clinical, management (diagnostic and therapeutic) and survival data for patients with Merkel carcinoma in the Lower Rhine region		The period from from January 1st, 1983 to December 31st, 2011 will be examined

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >18 years
Diagnosis of primary Merkel carcinoma (topographic code C44 morphological code 8247/3)
Diagnosis made between 1983 and 2011
Patient residing in the Bas-Rhin at the date of diagnosis
Patient who has given his consent for the use of his data for research purposes

Exclusion Criteria:

- Refusal to participate in research

Accepts Healthy Volunteers

Not provided

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 residing in the Bas-Rhin and diagnosed between 1983 and 2011 as having primitive Merkel arcinoma (topographic code C44 morphological code 8247/3)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dan LIPSKER, MD, PhD	Contact	33.3.88.11.61.79		dan.lipsker@chru-strasbourg.fr
Alice KIENY, MD	Contact	33.3.88.11.61.79		Alice.KIENY@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Dan LIPSKER, MD, PhD	University Hospital, Strasbourg, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Dermatologie	Recruiting	Strasbourg		67091	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided