Clinical trial NCT06483685: Radiopharmaceuticals Analysis for Detailed Insights And INternational Tracking of Safety
Official title: Global Insights Into Therapeutic Radiopharmaceuticals Safety: A Comprehensive Analysis From the WHO Pharmacovigilance Database (RADIANTS)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Side Effect of Drug
Keywords: Pharmacovigilance
Adverse Drug Reactions
Nuclear Medicine
Radiotherapeutics
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 500000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) related to radiopharmaceuticals

Brief summary: Little is known about cancer therapy-related radiopharmaceuticals drugs safety. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify and describe cases of cancer therapy-related radiopharmaceuticals drugs.

Detailed description: Radiopharmaceuticals drugs especially for therapeutic purposes are responsible of a wide range of side effects. The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of adverse drug reactions following treatment with radiopharmaceuticals drugs.

Eligibility criteria: Inclusion Criteria:

* cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase)

Exclusion Criteria:

* not related to radiopharmaceuticals

Primary outcomes:
measure: Toxicity of Radiopharmaceuticals drugs
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports through study completion, an average 5 years
Secondary outcomes:
measure: Individual safety case reports parameters
timeFrame: Through study completion, an average 5 years
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen Normandy University Hospital
state: Normandy
Study officials:
affiliation: CHU de Caen Normandie
name: Jonathan Vigne, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dolladille C, Ederhy S, Ezine E, Choquet S, Nguyen LS, Alexandre J, Moslehi JJ, Dechartres A, Salem JE. Chimeric antigen receptor T-cells safety: A pharmacovigilance and meta-analysis study. Am J Hematol. 2021 Sep 1;96(9):1101-1111. doi: 10.1002/ajh.26259. Epub 2021 Jun 23.
citation: Ladriere T, Faudemer J, Levigoureux E, Peyronnet D, Desmonts C, Vigne J. Safety and Therapeutic Optimization of Lutetium-177 Based Radiopharmaceuticals. Pharmaceutics. 2023 Apr 13;15(4):1240. doi: 10.3390/pharmaceutics15041240.
citation: Vigne J, Chretien B, Bignon AL, Bouhier-Leporrier K, Dolladille C. [177Lu]Lu-DOTATATE peptide receptor radionuclide therapy-associated myeloid neoplasms: insights from the WHO pharmacovigilance database. Eur J Nucl Med Mol Imaging. 2022 Aug;49(10):3332-3333. doi: 10.1007/s00259-022-05833-6. Epub 2022 May 6. No abstract available.