Responsible Side Effects Management in Oncology | NCT04623437

Studies
Responsible Side Effects Management in Oncology

NCT04623437

Sponsor

University Hospital Sestre Milosrdnice

Status

Completed

Last Update Posted

Nov 10, 2020Actual

Enrollment

267Actual

Phase

Not provided

Conditions

Pharmacovigilance
Oncology
Antineoplastic Treatment

Interventions

Not provided

Countries

Croatia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

Sep 5, 2017Actual

Completion Date

Sep 5, 2017Actual

First Submitted Date

Nov 4, 2020

First Submission Date that Met QC Criteria

Nov 4, 2020

First Posted Date

Nov 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2020

Last Update Posted Date

Nov 10, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Robert Šeparović, PhD MD, University Hospital Sestre MilosrdnicePrincipal Investigator

Lead Sponsor

University Hospital Sestre MilosrdniceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

267Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UHC Sestre milorsdnice		Zagreb	Croatia, Europe	10 000	Croatia

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided