Drug AllergyNCT04920721
Retrospective Study of Immediate Hypersensitivity (IHS) Reactions to Platinum Salts in the University Hospital of Nancy
An observational study of Drug Allergy, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Allergy
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2021to Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with suspected immediate hypersensitivity reactions to platinum salts
Who may be able to join
- adult
- suspected immediate hypersensitivity reaction to platinum salts
Who cannot join
- skin tests not achievable
Trial locations and contacts
1 site in 1 country.
Tania ADAM, Dr contact
Claudie Mouton-Faivre, Dr contact
France1 site, 1 recruiting
- Recruiting
CHRU Nancy
Nancy, Vandoeuvre-Lès-Nancy, 54500
Tania ADAM, Dr, t.adam@chru-nancy.fr
About this study
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.
- Conditions
- Drug Allergy
- Being tested
- no intervention
- Keywords
- immediate hypersensitivity, platinum salts, skin tests, tolerance induction
- Medical subject headings
- Drug Hypersensitivity, Hypersensitivity, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention descriptiv study
| Study group | Role | What they receive |
|---|---|---|
| Allergic | suspected of immediate hypersensitivity reaction to platinum salts with positiv skin tests Receives: Other: no intervention | |
| Non allergic | suspected of immediate hypersensitivity reaction to platinum salts with negativ skin tests Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Result of skin test
prick test and if negativ => intradermoreaction
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AllergyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ADAM Tania, Central Hospital, Nancy, France
- Investigators
- Tania ADAM, Dr, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920721
- Sponsor's protocol ID
- 2021PI002
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Immediate Hypersensitivity (IHS) Reactions to Platinum Salts in the University Hospital of Nancy
- ClinicalTrials.gov ID
- NCT04920721
- Acronym / sponsor ID
- 2021PI002
- Conditions
- Drug Allergy
- Keywords
- immediate hypersensitivity, platinum salts, skin tests, tolerance induction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allergic | – | Other: no interventionsuspected of immediate hypersensitivity reaction to platinum salts with positiv skin tests |
| Non allergic | – | Other: no interventionsuspected of immediate hypersensitivity reaction to platinum salts with negativ skin tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with suspected immediate hypersensitivity reactions to platinum salts
Key inclusion criteria (2 listed)
- adult
- suspected immediate hypersensitivity reaction to platinum salts
Key exclusion criteria (1 listed)
- skin tests not achievable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention descriptiv study | Other | Allergic, Non allergic |
Primary outcome
Result of skin test
Time frame: baseline
prick test and if negativ => intradermoreaction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tania ADAM, Dr contact
Claudie Mouton-Faivre, Dr contact
Tania ADAM, Dr principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Allergy, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tania ADAM, Dr (t.adam@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Result of skin test (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.