CancerNCT04774627
Pancytopenia Related to PARP Inhibitors (PancytoRIB)
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 adverse events such as pancytopenia. Today, data about pancytopenia are scarce. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- PARP inhibitor
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2021to 24 Mar 2021
- 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: Cancer patients treated with PARPi and experiencing pancytopenia.
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 (none) and pamiparib (none).
- Exclusion Criteria: chronology not compatible between the PARPi and adverse event.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pancytopenia Related to PARP Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database (PancytoRIB)
Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious adverse events such as pancytopenia. Today, data about pancytopenia are scarce.
The objective was to investigate reports of pancytopenia adverse events related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib and pamiparib 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 pancytopenia related to PARPi.
- Conditions
- Cancer
- Being tested
- PARP inhibitor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARP inhibitorDrug
Also called olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib
All patients treated at least with 1 PARPi
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancytopenia reports related to PARPi.
Identification of the pancytopenia adverse event related to PARP inhibitors reported in the World Health Organization's (WHO) database of individual safety case reports.
Measured: From inception to Feb, 2021
Secondary outcomes (3)
Description of the latency period since first PARPi exposure.
Measured: From inception to Feb, 2021
Description of the fatality rate.
Measured: From inception to Feb, 2021
Description of patients who experienced co-reported adverse events
Measured: From inception to Feb, 2021
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 start7 Feb 2021
- Primary completion27 Feb 2021
- Study completion24 Mar 2021
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
- 200 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
- NCT04774627
- Sponsor's protocol ID
- Pharmaco 20200210
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2021
- Last updated
- 23 Sep 2021
- 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 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancytopenia Related to PARP Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database (PancytoRIB)
- ClinicalTrials.gov ID
- NCT04774627
- Acronym / sponsor ID
- Pharmaco 20200210
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 7 Feb 2021 (actual)
- Primary completion
- 27 Feb 2021 (actual)
- Study completion
- 24 Mar 2021 (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 adverse events such as pancytopenia. Today, data about pancytopenia are scarce.
The objective was to investigate reports of pancytopenia adverse events related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib and pamiparib 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 pancytopenia related to PARPi.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cancer patients treated with PARPi and experiencing pancytopenia.
Key inclusion criteria (3 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 (none) and pamiparib (none).
- Exclusion Criteria: chronology not compatible between the PARPi and adverse event.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PARP inhibitorAlso: olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparibAll patients treated at least with 1 PARPi | Drug | – |
Primary outcome
Pancytopenia reports related to PARPi.
Time frame: From inception to Feb, 2021
Identification of the pancytopenia adverse event related to PARP inhibitors reported in the World Health Organization's (WHO) database of individual safety case reports.
3 secondary outcomes
Description of the latency period since first PARPi exposure.
Time frame: From inception to Feb, 2021
Description of the fatality rate.
Time frame: From inception to Feb, 2021
Description of patients who experienced co-reported adverse events
Time frame: From inception to Feb, 2021
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 23 Sep 2021.
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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 3 inclusion and 0 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 23 Sep 2021. 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?
Pancytopenia reports related to PARPi. (time frame: From inception to Feb, 2021). 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 23 Sep 2021.