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TelemedicineCO-SI-ONKONCT05043220

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

A study testing PPG and PROM in people with Telemedicine, run by Technical University of Munich at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Telemedicine
What is being tested?
PPG and PROM
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteGermany
Study dates
29 Sep 2021to 30 Apr 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinikum rechts der Isar, Frauenklinik, Technische Universität München

    Munich, 81675

Other trials in Germany

About this study

Official title: COVID-19-Prädiktoren: Klinische Studie Zur Sicherheit Von Gynäkologisch Onkologischen Patientinnen Unter Onkologischer Systemtherapie - CO-SI-ONKO-Studie

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.

Conditions
Telemedicine
Being tested
PPG and PROM

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PPG and PROMDevice

    description will follow

Study groups in NCT05043220
Study groupRoleWhat they receive
TelemedicineExperimentalTelemonitoring via PPG (photoplethysmography) and PROM (patient reported outcome monitoring) via app
Receives: Device: PPG and PROM

What is being measured

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

  1. Compliance

    Compliance is defined as wearing time of the in-ear-sensor.

    Measured: 3 months

  2. robustness of the ppg-signal

    number and duration of the ppg-signal transmitted

    Measured: 3 months

Secondary outcomes (7)

  1. number of correct- and false-positive alerts

    definition via comparison of alerts with clinical data

    Measured: 3 months

  2. number of contacts and hospitalization rates

    definition via comparison of alerts and resulting contacts and hospitalization rates with clinical data

    Measured: 3 months

  3. infections

    detection of infesctions via suspected ppg-signal transmitted or PRO-data. This results in blood test zu verify acute infections.

    Measured: 3 months

  4. therapy modifications

    dose-reductions (%), postponing of therapy cycles (time in days between actual and plannend date), therapy discontinuation

    Measured: 3 months

  5. effect on quality of life

    change in minimum 9 points in the EORTC QLQ-C30-questionnaire is evaluated as significant change. In questions 1-28: 28-112 points can be achieved: higher scores are associated with a worse outcome. In questions 29-30:2-14 points can be achieved: higher scores are associated with a better outcome.

    Measured: 3 months

  6. OS; PFS

    time between study inclusion and death; time between study inclusion and proven increasing tumor mass (number of days)

    Measured: 3 months

  7. health-related costs

    cost-effectiveness analysis

    Measured: 3 months

Timeline

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

  1. First posted14 Sep 2021
  2. Study start29 Sep 2021
  3. Primary completion31 Oct 2022
  4. Study completion30 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05043220
Sponsor's protocol ID
CO-SI-ONKO
Acronym
CO-SI-ONKO
Status last verified
Nov 2024
First submitted
13 Sep 2021
Last updated
22 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing PPG and PROM in people with Telemedicine, run by Technical University of Munich at 1 site in Germany.

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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 22 Nov 2024. 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 Germany. 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?

This study is still under way. Results are not available in the source record yet.

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?

Compliance (time frame: 3 months). 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?

On the ClinicalTrials.gov record for NCT05043220.

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 22 Nov 2024.

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