CancerRADIANTSNCT06483685
Radiopharmaceuticals Analysis for Detailed Insights And INternational Tracking of Safety
An observational study of Cancer and Side Effect of Drug, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Side Effect of Drug
- What is being tested?
- Radiopharmaceuticals drugs
- How many people
- 500,000 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2024to 1 Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) related to radiopharmaceuticals
Who may be able to join
- cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase)
Who cannot join
- not related to radiopharmaceuticals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Global Insights Into Therapeutic Radiopharmaceuticals Safety: A Comprehensive Analysis From the WHO Pharmacovigilance Database (RADIANTS)
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.
Read the 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.
- Conditions
- Cancer, Side Effect of Drug
- Being tested
- Radiopharmaceuticals drugs
- Keywords
- Pharmacovigilance, Adverse Drug Reactions, Nuclear Medicine, Radiotherapeutics
- Medical subject headings
- Neoplasms, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiopharmaceuticals drugsDrug
radiopharmaceuticals drugs included in the Anatomical Therapeutic Chemical (ATC) classification system.
| Study group | Role | What they receive |
|---|---|---|
| Adverse Events with Radiopharmaceuticals drugs | Cases reported in the World Health Organization (WHO) of patients treated by Radiopharmaceuticals drugs with reported toxicity Receives: Drug: Radiopharmaceuticals drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
weight in kilograms, height in meters, age in years, country, date of report in years, co-medication in active ingredients name, sex (male / female), severity (yes or no), death reported (yes or no), reporter qualification, action taken with drug, outcome (recovered, not recovered, role of co-medication (suspect, concomittant, unknown), drugs doses (MegaBecquerels, milligrams, grams, international units, milliliters), route of administration. Date of suspected drug administration, Start date and end date of reported adverse events. Dechallenge of suspected drugs (yes , no, unknown), Rechallenge of suspected drugs (yes , no, unknown).
Measured: Through study completion, an average 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start30 May 2024
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 500,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Vigne, PharmD, PhD, Principal investigator, CHU de Caen Normandie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483685
- Sponsor's protocol ID
- 20240531
- Other IDs
- RADIANTS
- Acronym
- RADIANTS
- Status last verified
- May 2024
- First submitted
- 3 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34057232Ladriere 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.
PubMed 37111725Vigne 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.
PubMed 35513605
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Insights Into Therapeutic Radiopharmaceuticals Safety: A Comprehensive Analysis From the WHO Pharmacovigilance Database (RADIANTS)
- ClinicalTrials.gov ID
- NCT06483685
- Acronym / sponsor ID
- RADIANTS / 20240531
- Conditions
- Cancer, Side Effect of Drug
- Keywords
- Pharmacovigilance, Adverse Drug Reactions, Nuclear Medicine, Radiotherapeutics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500,000 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 3 Jul 2024 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adverse Events with Radiopharmaceuticals drugs | – | Drug: Radiopharmaceuticals drugsCases reported in the World Health Organization (WHO) of patients treated by Radiopharmaceuticals drugs with reported toxicity |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) related to radiopharmaceuticals
Key inclusion criteria (1 listed)
- cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase)
Key exclusion criteria (1 listed)
- not related to radiopharmaceuticals
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 |
|---|---|---|
| Radiopharmaceuticals drugsradiopharmaceuticals drugs included in the Anatomical Therapeutic Chemical (ATC) classification system. | Drug | Adverse Events with Radiopharmaceuticals drugs |
Primary outcome
Toxicity of Radiopharmaceuticals drugs
Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports through study completion, an average 5 years
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)
1 secondary outcome
Individual safety case reports parameters
Time frame: Through study completion, an average 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 34057232Dolladille 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.
- Background: PubMed 37111725Ladriere 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.
- Results publication: PubMed 35513605Vigne 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.
- 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.
Jonathan Vigne, PharmD, PhD principal investigator
CHU de Caen Normandie
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 Cancer and Side Effect of Drug, run by University Hospital, Caen 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 1 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 3 Jul 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity of Radiopharmaceuticals drugs (time frame: Case reported in the World Health Organization (WHO) of individual safety case reports through study completion, an average 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06483685, which also lists 3 linked publications.
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 3 Jul 2024.