Assessment of Quality of Life of Children With Chronic Id... | NCT03123497

Studies
Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura (Kid's ITP Tools)

NCT03123497

Sponsor

University Hospital, Angers

Status

Unknown status

Last Update Posted

Mar 12, 2020Actual

Enrollment

183Estimated

Phase

Not provided

Conditions

Idiopathic Thrombocytopenic Purpura

Interventions

completion of questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2017Actual

Primary Completion Date

Oct 2020Estimated

Completion Date

Oct 30, 2020Estimated

First Submitted Date

Apr 12, 2017

First Submission Date that Met QC Criteria

Apr 18, 2017

First Posted Date

Apr 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2020

Last Update Posted Date

Mar 12, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Assessment of quality of life of patient with chronic idiopathic thrombocytopenic purpura according to the type of treatment

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

183Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Idiopathic Thrombocytopenic Purpura		completion of questionnaire	Other: completion of questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
completion of questionnaire	Other	completion of questionnaire for patient and parent	Idiopathic Thrombocytopenic Purpura

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
quality of life score according to type of treatment	quality of life score according to type of treatment	at inclusion visit

Secondary Outcomes

Measure	Description	Time Frame
number of hospitalisation and consults per year	number of hospitalisation and consults per year	at inclusion visit
description of general quality of life	use ped'sQL general

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children with Idiopathic thrombocytopenic purpura
aged between 1 and 17 year
Idiopathic thrombocytopenic purpura persistent at 12 months
obtention of informed consent

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

17 Years

Standard Ages

Child

Study Population

Children with idiopathic thombocytopenic purpura, aged between 1 and 17 year

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
marianne roumy	Contact	0241356385	+33	marianne.roumy@chu-angers.fr

Overall Officials

Name	Affiliation	Role
Isabelle Pellier, Pr	chu	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU d'Angers	Recruiting	Angers		49933	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016553	Purpura, Thrombocytopenic, Idiopathic

Ancestor Terms

ID	Term
D011696	Purpura, Thrombocytopenic
D011693	Purpura
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided