NCT04920721

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

1 month

First QC Date

June 4, 2021

Last Update Submit

June 4, 2021

Conditions

Drug Allergy

Keywords

immediate hypersensitivityplatinum saltsskin teststolerance induction

Outcome Measures

Primary Outcomes (1)

  • Result of skin test

    prick test and if negativ =\> intradermoreaction

    baseline

Study Arms (2)

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

no interventionOTHER

no intervention descriptiv study

AllergicNon allergic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with suspected immediate hypersensitivity reactions to platinum salts

You may qualify if:

  • adult
  • suspected immediate hypersensitivity reaction to platinum salts

You may not qualify if:

  • skin tests not achievable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Nancy, Vandoeuvre-Lès-Nancy, 54500, France

RECRUITING

MeSH Terms

Conditions

Drug HypersensitivityHypersensitivity, Immediate

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersHypersensitivityImmune System Diseases

Study Officials

  • Tania ADAM, Dr

    CHRU Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tania ADAM, Dr

CONTACT

t.adam@chru-nancy.fr

Claudie Mouton-Faivre, Dr

CONTACT

c.mouton@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 10, 2021

Study Start

June 1, 2021

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

June 10, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)