CancerNCT04774406
Arterial Hypertension Related to PARP Inhibitors (ArteRIB)
An observational study of Cancer, run by University Hospital, Caen at 1 site in France.
Trial summary
Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious (or not) adverse events such as hypertension whose data are scarce. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib
- How many people
- 2,336 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2021to 1 Sep 2022
- 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
- Child, Adult, Older adult
Study population: Cancer patients treated with PARPi and experiencing hypertension.
Who may be able to join
- case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,
- patients treated with at least 1 PARPi (with ATC classification system): olaparib (ATC L01XX46), niraparib (ATC L01XX54), rucaparib (ATC L01XX55), talazoparib (ATC L01XX60), veliparib, pamiparib, fluzoparib (none).
Who cannot join
- -chronology not compatible between the PARPi and adverse event
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arterial Hypertension With PARP Inhibitors in Cancer Patients: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database (ArteRIB)
Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious (or not) adverse events such as hypertension whose data are scarce.
The objective was to investigate reports of hypertension related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, and fluzoparib using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.
Read the detailed description
Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of hypertension AE related to PARPi.
- Conditions
- Cancer
- Being tested
- olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparibDrug
All patients treated at least with 1 PARPi (alone or in combination)
| Study group | Role | What they receive |
|---|---|---|
| parp inhibitors | All patients treated at least with 1 PARPi Receives: Drug: olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypertension reports related to PARPi.
Identification of the hypertension adverse event related to PARP inhibitors reported in the World Health Organization's (WHO) database of individual safety case reports.
Measured: From inception to 16 Feb, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start24 Feb 2021
- Primary completion9 May 2021
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cross-sectional
- Enrolment
- 2,336 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774406
- Sponsor's protocol ID
- Pharmaco 16022023
- Status last verified
- May 2023
- First submitted
- 25 Feb 2021
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Hypertension With PARP Inhibitors in Cancer Patients: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database (ArteRIB)
- ClinicalTrials.gov ID
- NCT04774406
- Acronym / sponsor ID
- Pharmaco 16022023
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,336 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 9 May 2021 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 1 Mar 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.
Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious (or not) adverse events such as hypertension whose data are scarce.
The objective was to investigate reports of hypertension related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, and fluzoparib using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.
Detailed description
Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of hypertension AE related to PARPi.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| parp inhibitors | – | Drug: olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparibAll patients treated at least with 1 PARPi |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Cancer patients treated with PARPi and experiencing hypertension.
Key inclusion criteria (2 listed)
- case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,
- patients treated with at least 1 PARPi (with ATC classification system): olaparib (ATC L01XX46), niraparib (ATC L01XX54), rucaparib (ATC L01XX55), talazoparib (ATC L01XX60), veliparib, pamiparib, fluzoparib (none).
Key exclusion criteria (1 listed)
- -chronology not compatible between the PARPi and adverse event
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 |
|---|---|---|
| olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparibAll patients treated at least with 1 PARPi (alone or in combination) | Drug | parp inhibitors |
Primary outcome
hypertension reports related to PARPi.
Time frame: From inception to 16 Feb, 2023
Identification of the hypertension adverse event related to PARP inhibitors reported in the World Health Organization's (WHO) database of individual safety case reports.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 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: finished, as of the sponsor's last update on 6 Jun 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
hypertension reports related to PARPi. (time frame: From inception to 16 Feb, 2023). 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 6 Jun 2023.