Retrospective Study of Immediate Hypersensitivity (IHS) R... | NCT04920721

Studies
Retrospective Study of Immediate Hypersensitivity (IHS) Reactions to Platinum Salts in the University Hospital of Nancy

NCT04920721

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Jun 10, 2021Actual

Enrollment

62Estimated

Phase

Not provided

Conditions

Drug Allergy

Interventions

no intervention

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

Jun 2021

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

Jun 2021Estimated

Primary Completion Date

Jul 2021Estimated

Completion Date

Jul 2021Estimated

First Submitted Date

Jun 4, 2021

First Submission Date that Met QC Criteria

Jun 4, 2021

First Posted Date

Jun 10, 2021Actual

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

Jun 4, 2021

Last Update Posted Date

Jun 10, 2021Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess the efficacy of skin tests with platinum salts in patients suspects with immediate hypersensitivity reactions.

All patients adressed in consultation to the Allergy Department of university hospital of nancy for an immediate hypersensitivity reaction to platinum salts between 2015 and 2021 were retrospectively recruited.

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

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

62Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Allergic		suspected of immediate hypersensitivity reaction to platinum salts with positiv skin tests	Other: no intervention
Non allergic		suspected of immediate hypersensitivity reaction to platinum salts with negativ skin tests	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention descriptiv study	Allergic Non allergic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Result of skin test	prick test and if negativ => intradermoreaction	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult
suspected immediate hypersensitivity reaction to platinum salts

Exclusion Criteria:

skin tests not achievable

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients with suspected immediate hypersensitivity reactions to platinum salts

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tania ADAM, Dr	Contact			t.adam@chru-nancy.fr
Claudie Mouton-Faivre, Dr	Contact			c.mouton@chru-nancy.fr

Overall Officials

Name	Affiliation	Role
Tania ADAM, Dr	CHRU Nancy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU Nancy	Recruiting	Nancy	Vandoeuvre-Lès-Nancy	54500	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
D004342	Drug Hypersensitivity
D006969	Hypersensitivity, Immediate

Ancestor Terms

ID	Term
D064420	Drug-Related Side Effects and Adverse Reactions
D064419	Chemically-Induced Disorders
D006967	Hypersensitivity
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided