Clinical trial · Interventional
Covid-19 Predictors: Safety of Gynecological Oncology Patients Undergoing Systemic Cancer Therapy
COVID-19-Prädiktoren: Klinische Studie Zur Sicherheit Von Gynäkologisch Onkologischen Patientinnen Unter Onkologischer Systemtherapie - CO-SI-ONKO-Studie
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Telemedicine | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PPG and PROM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Telemedicine
- description
- Telemonitoring via PPG (photoplethysmography) and PROM (patient reported outcome monitoring) via app
- interventionNames
- Device: PPG and PROM
Primary outcomes (2)
- measure
- Compliance
- timeFrame
- 3 months
- description
- Compliance is defined as wearing time of the in-ear-sensor.
- measure
- robustness of the ppg-signal
- timeFrame
- 3 months
- description
- number and duration of the ppg-signal transmitted
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available