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Covid-19 Predictors: Safety of Gynecological Oncology Patients Undergoing Chemotherapy (CO-SI-ONKO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05043220
Recruitment Status : Recruiting
First Posted : September 14, 2021
Last Update Posted : October 7, 2021
Sponsor:
Information provided by (Responsible Party):
Heike Jansen, Technische Universität München

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.

Condition or disease Intervention/treatment Phase
Telemedicine Device: PPG and PROM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: COVID-19-Prädiktoren: Klinische Studie Zur Sicherheit Von gynäkologisch Onkologischen Patientinnen Unter Chemotherapie - CO-SI-ONKO-Studie
Actual Study Start Date : September 29, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : August 31, 2022

Arm Intervention/treatment
Experimental: Telemedicine
Telemonitoring via PPG (photoplethysmography) and PROM (patient reported outcome monitoring) via app
Device: PPG and PROM
description will follow




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gynecological cancer
  • indication for chemotherapy
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05043220


Contacts
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Contact: Heike Jansen, Dr. med. +49-89-4140-2420 heike.jansen@tum.de

Locations
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Germany
Klinikum rechts der Isar, Frauenklinik, Technische Universität München Recruiting
Munich, Germany, 81675
Contact: Heike Jansen, Dr. med.    +49-89-4140-2420    heike.jansen@tum.de   
Contact: Marion Kiechle, Prof. Dr. med.    +49-89-4140-2420    marion.kiechle@tum.de   
Sub-Investigator: Anna Eichhorn, Dr. med.         
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: Heike Jansen, Dr. med Technische Universität München
Study Director: Marion Kiechle, Prof. Dr. med. Technische Universität München
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Responsible Party: Heike Jansen, Principal Investigator, Technische Universität München
ClinicalTrials.gov Identifier: NCT05043220    
Other Study ID Numbers: CO-SI-ONKO
First Posted: September 14, 2021    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No