Epidemiological Description of the Kaposi's Disease in Fr... | NCT03662828

Studies
Epidemiological Description of the Kaposi's Disease in France's Southeast

NCT03662828

Sponsor

Direction Centrale du Service de Santé des Armées

Status

Unknown status

Last Update Posted

May 14, 2019Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Kaposi's Disease

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

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Aug 2020Estimated

Completion Date

Aug 2020Estimated

First Submitted Date

Jul 23, 2018

First Submission Date that Met QC Criteria

Sep 5, 2018

First Posted Date

Sep 10, 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

May 13, 2019

Last Update Posted Date

May 14, 2019Actual

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 purpose of this study is to evaluate the prevalence of the Kaposi's disease in France's southeast on 10 years (from 2007 to 2017)

Detailed Description

Kaposi's disease is a multifocal disease with cutaneous expression in more than 95% of cases.

There are 4 forms : Mediterranean, Endemic (Sub-Saharan Africa), iatrogenic and epidemic (HIV) The physiological hypotheses to explain the disease are not clear. A proliferation of immunity cells in blood vessels and also an undetermined role of the human herpes virus 8 (HHV-8) could be involved.

The treatment is complex and not standardized. There are a lot of different treatments.

The purpose of this study is to evaluate the prevalence and described the characteristics and the treatment of the Kaposi's disease in the France's southeast on 10 years, from 2007 to 2017.

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of Kaposi's disease	Diagnosed patients with biopsy, in France's southeast	10 years (2007-2017)

Secondary Outcomes

Measure	Description	Time Frame
Descriptive analysis of the different form of the Kaposi's disease in the population	Mediterranean form, endemic form, iatrogenic form and epidemic form	10 years (2007-2017)
Descriptive analysis of the population : sociodemographic

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed patients with a Kaposi's disease by biopsy from January 2007 to December 2017

Exclusion Criteria:

Opposition to the use of personal data

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

Diagnosed patients with a Kaposi's disease by biopsy from January 2007 to December 2017

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Antoine Lacassagne		Nice	Alpes-Maritimes	06000	France
CHU Nice

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

Condition Browse Module

MeSH Terms

ID	Term
D014983	Xeroderma Pigmentosum

Ancestor Terms

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D012868	Skin Abnormalities
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided