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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03662828
Other study ID # KAPOSI-1
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date August 2020

Study information

Verified date February 2019
Source Direction Centrale du Service de Santé des Armées
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100
Est. completion date August 2020
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHI de Fréjus Fréjus Var
France HIA Laveran Marseille Bouche Du Rhone
France Centre Antoine Lacassagne Nice Alpes-Maritimes
France CHU Nice Nice Alpes-Maritimes
France Hôpital d'Instruction des Armées Sainte-Anne Toulon Var

Sponsors (1)

Lead Sponsor Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of Kaposi's disease Diagnosed patients with biopsy, in France's southeast 10 years (2007-2017)
Secondary 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)
Secondary Descriptive analysis of the population : sociodemographic sociodemographic characteristics 10 years (2007-2017)
Secondary Descriptive analysis of the population : paraclinical paraclinical characteristics 10 years (2007-2017)
Secondary Descriptive analysis of the population : clinical clinical characteristics 10 years (2007-2017)
Secondary Descriptive analysis of the population : therapeutic therapeutic care 10 years (2007-2017)
Secondary Survival analysis mortality rate 10 years (2007-2017)