Idiopathic Thrombocytopenic PurpuraKITNCT03123497
Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura (Kid's ITP Tools)
An observational study of Idiopathic Thrombocytopenic Purpura, run by University Hospital, Angers at 1 site in France.
Trial summary
Assessment of quality of life of patient with chronic idiopathic thrombocytopenic purpura according to the type of treatment Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura
- What is being tested?
- completion of questionnaire
- How many people
- 183 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2017to 30 Oct 2020
- How long will I take part?
- 2 Months
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with idiopathic thombocytopenic purpura, aged between 1 and 17 year
Who may be able to join
- children with Idiopathic thrombocytopenic purpura
- aged between 1 and 17 year
- Idiopathic thrombocytopenic purpura persistent at 12 months
- obtention of informed consent
Who cannot join
- Persistant/acute Idiopathic thrombocytopenic purpura
- concomittant chronic disease, stabilized or not
- Concomittant disease with life expectancy < 1 year
- Person who have not belong to a social security scheme
- Secondary Idiopathic thrombocytopenic purpura
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU d'Angers
Angers, 49933
Marianne Roumy, 0241356385 ext. +33, marianne.roumy@chu-angers.fr
Isabelle Pellier, Pr
About this study
Official title: Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura
Assessment of quality of life of patient with chronic idiopathic thrombocytopenic purpura according to the type of treatment
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Being tested
- completion of questionnaire
- Keywords
- Idiopathic Thrombocytopenic Purpura
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
completion of questionnaireOther
completion of questionnaire for patient and parent
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Thrombocytopenic Purpura | completion of questionnaire Receives: Other: completion of questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life score according to type of treatment
quality of life score according to type of treatment
Measured: at inclusion visit
Secondary outcomes (4)
number of hospitalisation and consults per year
number of hospitalisation and consults per year
Measured: at inclusion visit
description of general quality of life
use ped'sQL general
Measured: at inclusion visit
description of general quality of life
use ped'sQL fatigue
Measured: at inclusion visit
description of awareness of parent and patient about Idiopathic thrombocytopenic purpura
use Kid's ITO Tools questionnaire
Measured: at inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start12 Apr 2017
- Primary completionOct 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 183 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Isabelle Pellier, Pr, Principal investigator, chu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123497
- Sponsor's protocol ID
- 49RC17_0011
- Acronym
- KIT
- Status last verified
- Mar 2020
- First submitted
- 12 Apr 2017
- Last updated
- 12 Mar 2020
- 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 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT03123497
- Acronym / sponsor ID
- KIT / 49RC17_0011
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Keywords
- Idiopathic Thrombocytopenic Purpura
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 21 Apr 2017 (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.
Assessment of quality of life of patient with chronic idiopathic thrombocytopenic purpura according to the type of treatment
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Thrombocytopenic Purpura | – | Other: completion of questionnairecompletion of questionnaire |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with idiopathic thombocytopenic purpura, aged between 1 and 17 year
Key inclusion criteria (4 listed)
- children with Idiopathic thrombocytopenic purpura
- aged between 1 and 17 year
- Idiopathic thrombocytopenic purpura persistent at 12 months
- obtention of informed consent
Key exclusion criteria (5 listed)
- Persistant/acute Idiopathic thrombocytopenic purpura
- concomittant chronic disease, stabilized or not
- Concomittant disease with life expectancy < 1 year
- Person who have not belong to a social security scheme
- Secondary Idiopathic thrombocytopenic purpura
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| completion of questionnairecompletion of questionnaire for patient and parent | Other | Idiopathic Thrombocytopenic Purpura |
Primary outcome
quality of life score according to type of treatment
Time frame: at inclusion visit
quality of life score according to type of treatment
4 secondary outcomes
number of hospitalisation and consults per year
Time frame: at inclusion visit
description of general quality of life
Time frame: at inclusion visit
description of general quality of life
Time frame: at inclusion visit
description of awareness of parent and patient about Idiopathic thrombocytopenic purpura
Time frame: at inclusion visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- 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.
Isabelle Pellier, Pr principal investigator
chu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Thrombocytopenic Purpura, run by University Hospital, Angers at 1 site 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 4 inclusion and 5 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 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact marianne roumy (0241356385 ext. +33, marianne.roumy@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life score according to type of treatment (time frame: at inclusion visit). 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 12 Mar 2020.