Kaposi's DiseaseKAPOSI-1NCT03662828
Epidemiological Description of the Kaposi's Disease in France's Southeast
An observational study of Kaposi's Disease, run by Direction Centrale du Service de Santé des Armées at 5 sites in France.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kaposi's Disease
- How many people
- 100 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Aug 2018to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed patients with a Kaposi's disease by biopsy from January 2007 to December 2017
Who may be able to join
- Diagnosed patients with a Kaposi's disease by biopsy from January 2007 to December 2017
Who cannot join
- Opposition to the use of personal data
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHI de Fréjus
Fréjus, Var, 83600
HIA Laveran
Marseille, Bouche Du Rhone, 13384
Centre Antoine Lacassagne
Nice, Alpes-Maritimes, 06000
CHU Nice
Nice, Alpes-Maritimes, 06000
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, Var, 83000
About this study
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)
Read the 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.
- Conditions
- Kaposi's Disease
- Keywords
- Kaposi's disease, HHV8, Prevalence
- Medical subject headings
- Xeroderma Pigmentosum
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Kaposi's disease
Diagnosed patients with biopsy, in France's southeast
Measured: 10 years (2007-2017)
Secondary outcomes (6)
Descriptive analysis of the different form of the Kaposi's disease in the population
Mediterranean form, endemic form, iatrogenic form and epidemic form
Measured: 10 years (2007-2017)
Descriptive analysis of the population : sociodemographic
sociodemographic characteristics
Measured: 10 years (2007-2017)
Descriptive analysis of the population : paraclinical
paraclinical characteristics
Measured: 10 years (2007-2017)
Descriptive analysis of the population : clinical
clinical characteristics
Measured: 10 years (2007-2017)
Descriptive analysis of the population : therapeutic
therapeutic care
Measured: 10 years (2007-2017)
Survival analysis
mortality rate
Measured: 10 years (2007-2017)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Aug 2018
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kaposi's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662828
- Sponsor's protocol ID
- KAPOSI-1
- Acronym
- KAPOSI-1
- Status last verified
- Feb 2019
- First submitted
- 23 Jul 2018
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Description of the Kaposi's Disease in France's Southeast
- ClinicalTrials.gov ID
- NCT03662828
- Acronym / sponsor ID
- KAPOSI-1 / KAPOSI-1
- Conditions
- Kaposi's Disease
- Keywords
- Kaposi's disease, HHV8, Prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed patients with a Kaposi's disease by biopsy from January 2007 to December 2017
Key inclusion criteria (1 listed)
- Diagnosed patients with a Kaposi's disease by biopsy from January 2007 to December 2017
Key exclusion criteria (1 listed)
- Opposition to the use of personal data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Kaposi's disease
Time frame: 10 years (2007-2017)
Diagnosed patients with biopsy, in France's southeast
6 secondary outcomes
Descriptive analysis of the different form of the Kaposi's disease in the population
Time frame: 10 years (2007-2017)
Descriptive analysis of the population : sociodemographic
Time frame: 10 years (2007-2017)
Descriptive analysis of the population : paraclinical
Time frame: 10 years (2007-2017)
Descriptive analysis of the population : clinical
Time frame: 10 years (2007-2017)
Descriptive analysis of the population : therapeutic
Time frame: 10 years (2007-2017)
Survival analysis
Time frame: 10 years (2007-2017)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kaposi's Disease, run by Direction Centrale du Service de Santé des Armées at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Kaposi's disease (time frame: 10 years (2007-2017)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.