Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05043220

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Telemedicine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum rechts der Isar, Frauenklinik, Technische Universität München

Munich, 81675, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PPG and PROM

Device

description will follow

Primary outcomes

  1. Compliance

    Time frame: 3 months

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

  2. robustness of the ppg-signal

    Time frame: 3 months

    number and duration of the ppg-signal transmitted

Secondary outcomes

  1. number of correct- and false-positive alerts

    Time frame: 3 months

    definition via comparison of alerts with clinical data

  2. number of contacts and hospitalization rates

    Time frame: 3 months

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

  3. infections

    Time frame: 3 months

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

  4. therapy modifications

    Time frame: 3 months

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

  5. effect on quality of life

    Time frame: 3 months

    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.

  6. OS; PFS

    Time frame: 3 months

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

  7. health-related costs

    Time frame: 3 months

    cost-effectiveness analysis

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Acronym: CO-SI-ONKO

Important dates

Study start
2021
Primary completion
2022
Study completion
2025
First posted
Sep 14, 2021
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.