Covid-19 Predictors: Safety of Gynecological Oncology Pat... | NCT05043220

Studies
Covid-19 Predictors: Safety of Gynecological Oncology Patients Undergoing Systemic Cancer Therapy

NCT05043220

Sponsor

Technical University of Munich

Status

Active, not recruiting

Last Update Posted

Nov 22, 2024Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Telemedicine

Interventions

PPG and PROM

Countries

Germany

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 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 29, 2021Actual

Primary Completion Date

Oct 31, 2022Actual

Completion Date

Apr 30, 2025Estimated

First Submitted Date

Sep 13, 2021

First Submission Date that Met QC Criteria

Sep 13, 2021

First Posted Date

Sep 14, 2021Actual

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 19, 2024

Last Update Posted Date

Nov 22, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We designed a monocenter prospective cohort study using PROM via app and remote monitoring via pho-toplethysmography (PPG). The application of these technologies enables an early detection of infections and therefore initiation of medical interventions. The study is conducted as feasibility analysis; primary endpoints are adherence (according to wearing time) and technical robustness.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Telemedicine	Experimental	Telemonitoring via PPG (photoplethysmography) and PROM (patient reported outcome monitoring) via app	Device: PPG and PROM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PPG and PROM	Device	description will follow	Telemedicine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compliance	Compliance is defined as wearing time of the in-ear-sensor.	3 months
robustness of the ppg-signal	number and duration of the ppg-signal transmitted	3 months

Secondary Outcomes

Measure	Description	Time Frame
number of correct- and false-positive alerts	definition via comparison of alerts with clinical data	3 months
number of contacts and hospitalization rates	definition via comparison of alerts and resulting contacts and hospitalization rates with clinical data

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

gynecological cancer
indication for systemic cancer therapy
patients who are legally competent and able to understand and follow instructions of the study staff
present informed consent

Exclusion Criteria:

no use if internet or applications
persons who are in a dependency or employment relationship with the study center
positive proof of COVID-19
affection of the external auditory canal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heike Jansen, Dr. med	Technical University of Munich	Principal Investigator
Marion Kiechle, Prof. Dr. med.	Technical University of Munich	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum rechts der Isar, Frauenklinik, Technische Universität München		Munich		81675	Germany