PharmacovigilanceR-SEMONCT04623437

Responsible Side Effects Management in Oncology

An observational study of Pharmacovigilance and Oncology, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study of pharmacovigilance in oncology. Monitoring and management of AEs during antineoplastic treatment. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pharmacovigilance, Oncology, Antineoplastic Treatment
How many people: 267 participants
Where: 1 siteCroatia
Study dates: 1 Jul 2017to 5 Sep 2017
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: all cancer patients actively receiving systemic antineoplastic treatment, ECOG 0-2

Who may be able to join

all cancer patients receiving systemic antineoplastic treatment, ECOG 0-2

Who cannot join

age <18, >75; other active and severe comorbidities; no solid cancer; IUC patients

Trial locations and contacts

1 site in 1 country.

Croatia1 site

UHC Sestre milorsdnice
Zagreb, Croatia, Europe, 10 000

Other trials in Croatia

About this study

Official title: Comprehensive Antineoplastic Therapy Adverse Events Monitoring and Report

Study of pharmacovigilance in oncology. Monitoring and management of AEs during antineoplastic treatment.

Read the detailed description

Monitoring and management of AE's during antineoplastic treatment. Comparison of AE's reported by patient with the ones recognised by the oncologist, and vice versa, during antineoplastic treatment.

Conditions: Pharmacovigilance, Oncology, Antineoplastic Treatment
Keywords: pharmacovigilance in oncology, antineoplastic treatment, adverse events
Medical subject headings: Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

comparison of perspectives
comparison between patient's and oncologist's perspective on severity of AE's during antineoplastic treatment
Measured: may 2016 until october 2016

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20175 Sep 2017

First posted10 Nov 2020
Study start1 Jul 2017
Primary completion5 Sep 2017
Study completion5 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PharmacovigilanceStudies 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: Cohort
Time perspective: Prospective
Enrolment: 267 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04623437
Sponsor's protocol ID: 2312201522122016
Acronym: R-SEMO
Status last verified: Nov 2020
First submitted: 4 Nov 2020
Last updated: 10 Nov 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comprehensive Antineoplastic Therapy Adverse Events Monitoring and Report
ClinicalTrials.gov ID: NCT04623437
Acronym / sponsor ID: R-SEMO / 2312201522122016
Conditions: Pharmacovigilance, Oncology, Antineoplastic Treatment
Keywords: pharmacovigilance in oncology, antineoplastic treatment, adverse events
Study type: Observational
Recruitment status: Completed
Enrolment: 267 participants (actual)
Lead sponsor: University Hospital Sestre MilosrdniceUniversity, hospital or other
Study start: 1 Jul 2017 (actual)
Primary completion: 5 Sep 2017 (actual)
Study completion: 5 Sep 2017 (actual)
First posted: 10 Nov 2020 (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.

Study of pharmacovigilance in oncology. Monitoring and management of AEs during antineoplastic treatment.

Detailed description

Monitoring and management of AE's during antineoplastic treatment. Comparison of AE's reported by patient with the ones recognised by the oncologist, and vice versa, during antineoplastic treatment.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: all cancer patients actively receiving systemic antineoplastic treatment, ECOG 0-2

Key inclusion criteria (1 listed)

all cancer patients receiving systemic antineoplastic treatment, ECOG 0-2

Key exclusion criteria (1 listed)

age <18, >75; other active and severe comorbidities; no solid cancer; IUC patients

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

comparison of perspectives
Time frame: may 2016 until october 2016
comparison between patient's and oncologist's perspective on severity of AE's during antineoplastic treatment

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 10 Nov 2020.

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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 Pharmacovigilance and Oncology, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.

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: finished, as of the sponsor's last update on 10 Nov 2020. 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 Croatia. 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?

comparison of perspectives (time frame: may 2016 until october 2016). 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 NCT04623437.

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 10 Nov 2020.