- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04920721
Retrospective Study of Immediate Hypersensitivity (IHS) Reactions to Platinum Salts in the University Hospital of Nancy
June 4, 2021 updated by: ADAM Tania, Central Hospital, Nancy, France
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
62
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tania ADAM, Dr
- Email: t.adam@chru-nancy.fr
Study Contact Backup
- Name: Claudie Mouton-Faivre, Dr
- Email: c.mouton@chru-nancy.fr
Study Locations
-
-
Vandoeuvre-Lès-Nancy
-
Nancy, Vandoeuvre-Lès-Nancy, France, 54500
- Recruiting
- CHRU Nancy
-
Contact:
- Tania ADAM, Dr
- Email: t.adam@chru-nancy.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients with suspected immediate hypersensitivity reactions to platinum salts
Description
Inclusion Criteria:
- adult
- suspected immediate hypersensitivity reaction to platinum salts
Exclusion Criteria:
- skin tests not achievable
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Allergic
suspected of immediate hypersensitivity reaction to platinum salts with positiv skin tests
|
no intervention descriptiv study
|
Non allergic
suspected of immediate hypersensitivity reaction to platinum salts with negativ skin tests
|
no intervention descriptiv study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Result of skin test
Time Frame: baseline
|
prick test and if negativ => intradermoreaction
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tania ADAM, Dr, CHRU Nancy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2021
Primary Completion (Anticipated)
July 1, 2021
Study Completion (Anticipated)
July 1, 2021
Study Registration Dates
First Submitted
June 4, 2021
First Submitted That Met QC Criteria
June 4, 2021
First Posted (Actual)
June 10, 2021
Study Record Updates
Last Update Posted (Actual)
June 10, 2021
Last Update Submitted That Met QC Criteria
June 4, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021PI002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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