OncologyNCT05825794
Active Pharmacovigilance of Anti-cancer Medicines
An observational study of Oncology and Drugs, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
Pharmacovigilance (PV), defined by the World Health Organization (WHO) as the "science and activities related to the detection, evaluation, understanding and prevention of adverse effects or any other drug-related problem", aims to improve patient safety and quality of life. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Oncology, Drugs, Pharmacovigilance
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 28 Oct 2021to 31 Dec 2023
- 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 Up to 25 years
- All sexes
- Child, Adult
Study population: Pediatric and young adult patients requiring the administration of anticancer drugs
Who may be able to join
- patients aged <25 years;
- receiving cytotoxic, targeted-therapy, immunotherapy drugs for the treatment of solid and hematologic cancers
- giving consent to study participation
Who cannot join
- presence of cognitive problems
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS materno infantile Burlo Garofolo
Trieste, 34137
Marta Trojniak, +390403785111, marta.trojniak@burlo.trieste.it
About this study
Official title: Active Pharmacovigilance of Anti-cancer Medicines in Pediatric and Young Adult Patients.
Pharmacovigilance (PV), defined by the World Health Organization (WHO) as the "science and activities related to the detection, evaluation, understanding and prevention of adverse effects or any other drug-related problem", aims to improve patient safety and quality of life. There are several objectives of PV, starting with the collection and management of safety data, to promote the safe and effective use of medicines. PV also aims to provide information on drug safety to health professionals and patients, and it contributes to updating drug labels. Finally, it is active in risk management, risk minimization and the prevention of adverse effects and other drug-related problems. As defined by WHO, an adverse event (AE) is "any untoward medical occurrence that may be present during treatment with a medicine, but which does not necessarily have a causal relationship with this treatment". When there is a causal relationship with the treatment, an AE is classified as an adverse drug reaction (ADR). The collection and reporting of AEs is a process that starts from the drug development phase and proceeds continuously throughout the life cycle of the drug, and it aims to assess the benefits-to-toxicity ratios (in other words, the safety and efficacy) of all medicines. Reports of ADRs must accurately describe the case and be meaningful to health professionals worldwide. The aim of this project is to evaluate the impact of an active prescription surveillance of anti-cancer drugs carried out by the clinical pharmacist in pediatrics and young adults.
- Conditions
- Oncology, Drugs, Pharmacovigilance
- Keywords
- Oncology, Drugs, Active pharmacovigilance
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantify the number of grade 3-5 ADRs reported during the active surveillance period
ADRs grades will be standardized using the Common Terminology Criteria for Adverse Events (CTCAE) v4.3.
Measured: Through study completion, an average of 3 years
To compare the number of grade 3-5 ADRs reported during the active surveillance period with the number of grade 3-5 ADRs reported in the previous years
Period of equal length will be compared
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start28 Oct 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Trojniak, PharmD, Principal investigator, IRCCS materno infantile Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825794
- Sponsor's protocol ID
- AIFA FVG 2019
- Status last verified
- Apr 2023
- First submitted
- 29 Mar 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Pharmacovigilance of Anti-cancer Medicines in Pediatric and Young Adult Patients.
- ClinicalTrials.gov ID
- NCT05825794
- Acronym / sponsor ID
- AIFA FVG 2019
- Conditions
- Oncology, Drugs, Pharmacovigilance
- Keywords
- Oncology, Drugs, Active pharmacovigilance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Apr 2023 (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.
Pharmacovigilance (PV), defined by the World Health Organization (WHO) as the "science and activities related to the detection, evaluation, understanding and prevention of adverse effects or any other drug-related problem", aims to improve patient safety and quality of life. There are several objectives of PV, starting with the collection and management of safety data, to promote the safe and effective use of medicines. PV also aims to provide information on drug safety to health professionals and patients, and it contributes to updating drug labels. Finally, it is active in risk management, risk minimization and the prevention of adverse effects and other drug-related problems. As defined by WHO, an adverse event (AE) is "any untoward medical occurrence that may be present during treatment with a medicine, but which does not necessarily have a causal relationship with this treatment". When there is a causal relationship with the treatment, an AE is classified as an adverse drug reaction (ADR). The collection and reporting of AEs is a process that starts from the drug development phase and proceeds continuously throughout the life cycle of the drug, and it aims to assess the benefits-to-toxicity ratios (in other words, the safety and efficacy) of all medicines. Reports of ADRs must accurately describe the case and be meaningful to health professionals worldwide. The aim of this project is to evaluate the impact of an active prescription surveillance of anti-cancer drugs carried out by the clinical pharmacist in pediatrics and young adults.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Pediatric and young adult patients requiring the administration of anticancer drugs
Key inclusion criteria (3 listed)
- patients aged <25 years;
- receiving cytotoxic, targeted-therapy, immunotherapy drugs for the treatment of solid and hematologic cancers
- giving consent to study participation
Key exclusion criteria (1 listed)
- presence of cognitive problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To quantify the number of grade 3-5 ADRs reported during the active surveillance period
Time frame: Through study completion, an average of 3 years
ADRs grades will be standardized using the Common Terminology Criteria for Adverse Events (CTCAE) v4.3.
To compare the number of grade 3-5 ADRs reported during the active surveillance period with the number of grade 3-5 ADRs reported in the previous years
Time frame: Through study completion, an average of 3 years
Period of equal length will be compared
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 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.
Marta Trojniak, PharmD principal investigator
IRCCS materno infantile Burlo Garofolo
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 Oncology and Drugs, run by IRCCS Burlo Garofolo at 1 site in Italy.
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 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 24 Apr 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 Italy. 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?
Contact Marta Paulina Trojniak, PharmD (+390403785111, martapaulina.trojniak@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To quantify the number of grade 3-5 ADRs reported during the active surveillance period (time frame: Through study completion, an average of 3 years). The study lists 2 primary outcomes in all. 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 24 Apr 2023.