NCT04623437

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2017

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

November 4, 2020

Last Update Submit

November 4, 2020

Conditions

PharmacovigilanceOncologyAntineoplastic Treatment

Keywords

pharmacovigilance in oncologyantineoplastic treatmentadverse events

Outcome Measures

Primary Outcomes (1)

  • comparison of perspectives

    comparison between patient's and oncologist's perspective on severity of AE's during antineoplastic treatment

    may 2016 until october 2016

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHC Sestre milorsdnice

Zagreb, Croatia, Europe, 10 000, Croatia

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD MD

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 10, 2020

Study Start

July 1, 2017

Primary Completion

September 5, 2017

Study Completion

September 5, 2017

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations

CR(1)