Radiopharmaceuticals Analysis for Detailed Insights And INternational Tracking of Safety

NCT ID: NCT06483685

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

500000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-30

Study Completion Date

2024-08-01

Brief Summary

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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

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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.

Conditions

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Cancer Side Effect of Drug

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Adverse Events with Radiopharmaceuticals drugs

Cases reported in the World Health Organization (WHO) of patients treated by Radiopharmaceuticals drugs with reported toxicity

Radiopharmaceuticals drugs

Intervention Type DRUG

radiopharmaceuticals drugs included in the Anatomical Therapeutic Chemical (ATC) classification system.

Interventions

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Radiopharmaceuticals drugs

radiopharmaceuticals drugs included in the Anatomical Therapeutic Chemical (ATC) classification system.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* not related to radiopharmaceuticals
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Vigne, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Caen Normandie

Locations

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Caen Normandy University Hospital

Caen, Normandy, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 34057232 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37111725 (View on PubMed)

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.

Reference Type RESULT
PMID: 35513605 (View on PubMed)

Other Identifiers

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RADIANTS

Identifier Type: OTHER

Identifier Source: secondary_id

20240531

Identifier Type: -

Identifier Source: org_study_id

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