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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662828
Recruitment Status : Enrolling by invitation
First Posted : September 10, 2018
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Direction Centrale du Service de Santé des Armées

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)

Condition or disease
Kaposi's Disease

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Epidemiological Description of the Kaposi's Disease in France's Southeast
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Prevalence of Kaposi's disease [ Time Frame: 10 years (2007-2017) ]
    Diagnosed patients with biopsy, in France's southeast


Secondary Outcome Measures :
  1. 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

  2. Descriptive analysis of the population : sociodemographic [ Time Frame: 10 years (2007-2017) ]
    sociodemographic characteristics

  3. Descriptive analysis of the population : paraclinical [ Time Frame: 10 years (2007-2017) ]
    paraclinical characteristics

  4. Descriptive analysis of the population : clinical [ Time Frame: 10 years (2007-2017) ]
    clinical characteristics

  5. Descriptive analysis of the population : therapeutic [ Time Frame: 10 years (2007-2017) ]
    therapeutic care

  6. Survival analysis [ Time Frame: 10 years (2007-2017) ]
    mortality rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosed patients with a Kaposi's disease by biopsy from January 2007 to December 2017
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662828


Locations
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France
Centre Antoine Lacassagne
Nice, Alpes-Maritimes, France, 06000
CHU Nice
Nice, Alpes-Maritimes, France, 06000
HIA Laveran
Marseille, Bouche Du Rhone, France, 13384
CHI de Fréjus
Fréjus, Var, France, 83600
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, Var, France, 83000
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées
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Responsible Party: Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier: NCT03662828    
Other Study ID Numbers: KAPOSI-1
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Direction Centrale du Service de Santé des Armées:
Kaposi's disease
HHV8
Prevalence
Additional relevant MeSH terms:
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Xeroderma Pigmentosum
Precancerous Conditions
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Photosensitivity Disorders
Skin Diseases
Pigmentation Disorders
DNA Repair-Deficiency Disorders
Metabolic Diseases