Epidemiological Description of the Kaposi's Disease in France's Southeast (KAPOSI-1)

May 13, 2019 updated by: Direction Centrale du Service de Santé des Armées
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)

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06000
        • CHU Nice
      • Nice, Alpes-Maritimes, France, 06000
        • Centre Antoine Lacassagne
    • Bouche Du Rhone
      • Marseille, Bouche Du Rhone, France, 13384
        • Hia Laveran
    • Var
      • Fréjus, Var, France, 83600
        • CHI de Fréjus
      • Toulon, Var, France, 83000
        • Hôpital d'Instruction des Armées Sainte-Anne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptive analysis of the different form of the Kaposi's disease in the population
Time Frame: 10 years (2007-2017)
Mediterranean form, endemic form, iatrogenic form and epidemic form
10 years (2007-2017)
Descriptive analysis of the population : sociodemographic
Time Frame: 10 years (2007-2017)
sociodemographic characteristics
10 years (2007-2017)
Descriptive analysis of the population : paraclinical
Time Frame: 10 years (2007-2017)
paraclinical characteristics
10 years (2007-2017)
Descriptive analysis of the population : clinical
Time Frame: 10 years (2007-2017)
clinical characteristics
10 years (2007-2017)
Descriptive analysis of the population : therapeutic
Time Frame: 10 years (2007-2017)
therapeutic care
10 years (2007-2017)
Survival analysis
Time Frame: 10 years (2007-2017)
mortality rate
10 years (2007-2017)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Direction Centrale du Service de Santé des Armées

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

July 23, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAPOSI-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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