Radiopharmaceuticals Analysis for Detailed Insights And INternational Tracking of Safety

NCT06483685 | Active Not Recruiting

• 2 other identifiers: 20240531RADIANTS
• Study Type: observational
• Target: 500,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Side Effect of Drug

Keywords

Pharmacovigilance; Adverse Drug Reactions; Nuclear Medicine; Radiotherapeutics

Outcome Measures

Primary Outcomes (1)

• Toxicity of Radiopharmaceuticals drugs

  Identification and report of toxicities of radiopharmaceuticals drugs. The research includes the report with MedDRA terms: System organ class (SOC), Preferred terms (PT), High level group term (HLGT), High level term (HLT)

  Case reported in the World Health Organization (WHO) of individual safety case reports through study completion, an average 5 years

Secondary Outcomes (1)

• Individual safety case reports parameters

  Through study completion, an average 5 years

Study Arms (1)

Adverse Events with Radiopharmaceuticals drugs

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

Drug: Radiopharmaceuticals drugs

Interventions

Radiopharmaceuticals drugs DRUG

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

Adverse Events with Radiopharmaceuticals drugs

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• not related to radiopharmaceuticals

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen Normandy University Hospital

Caen, Normandy, 14033, France

Location

Related Publications (3)

• 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.

  PMID: 34057232 BACKGROUND

• 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.

  PMID: 37111725 BACKGROUND

• 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.

  PMID: 35513605 RESULT

MeSH Terms

Conditions

Neoplasms; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Jonathan Vigne, PharmD, PhD

  CHU de Caen Normandie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: July 3, 2024
• Study Start: May 30, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)