Observatory of Immunological Thrombopenic Purpura in the... | NCT06556888

Studies
Observatory of Immunological Thrombopenic Purpura in the Brest Region

NCT06556888

Sponsor

University Hospital, Brest

Status

Recruiting

Last Update Posted

Aug 16, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Immune Thrombocytopenia

Interventions

Not provided

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

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 20, 2019Actual

Primary Completion Date

Nov 19, 2020Actual

Completion Date

Nov 30, 2039Estimated

First Submitted Date

Nov 19, 2020

First Submission Date that Met QC Criteria

Aug 13, 2024

First Posted Date

Aug 16, 2024Actual

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

Aug 13, 2024

Last Update Posted Date

Aug 16, 2024Actual

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

Database of patients with ITP, diagnosed, treated and followed in the Brest University Hospital.

Detailed Description

Creation of a global clinical and biological database for all patients diagnosed, treated and followed for ITP in the University Hospital of Brest.

UHB is the regional reference center (competence center) on hemorrhagic diseases.

Dr Pan-Petesch, who is responsible of the local competence center, is affiliated to the national sector of auto-immune cytopenias CERECAI-MARIH).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Description chronicity	Identification/description of risk factors of chronicity	1 year
Description treatment responses	Identification/ description of risk factors of bad responses	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with ITP agree to participate

Exclusion Criteria:

Other thrombocythopenia other than ITP
Patients Under guardianship
Patients without national social security

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients with ITP diagnosed, treated or followed at UHB

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Brigitte Pan-Petesch, MD	Contact	33298223650		brigitte.pan-petesch@chu-brest.fr
Veronique Kouassi	Contact	33298223333		veronique.kouassi@chu-brest.fr

Overall Officials

Name	Affiliation	Role
Brigitte Pan-Petesch, MD	UHB	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hematology Department - Institute of Oncology and Hematology, University Hospital of Brest	Recruiting	Brest	Brittany Region	29609	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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