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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

Tracking Information
First Submitted Date  ICMJE September 13, 2021
First Posted Date  ICMJE September 14, 2021
Last Update Posted Date October 7, 2021
Actual Study Start Date  ICMJE September 29, 2021
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2021)
  • Compliance [ Time Frame: 3 months ]
    Compliance is defined as wearing time of the in-ear-sensor.
  • robustness of the ppg-signal [ Time Frame: 3 months ]
    number and duration of the ppg-signal transmitted
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2021)
  • number of correct- and false-positive alerts [ Time Frame: 3 months ]
    definition via comparison of alerts with clinical data
  • number of contacts and hospitalization rates [ Time Frame: 3 months ]
    definition via comparison of alerts and resulting contacts and hospitalization rates with clinical data
  • 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.
  • therapy modifications [ Time Frame: 3 months ]
    dose-reductions (%), postponing of therapy cycles (time in days between actual and plannend date), therapy discontinuation
  • 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.
  • OS; PFS [ Time Frame: 3 months ]
    time between study inclusion and death; time between study inclusion and proven increasing tumor mass (number of days)
  • health-related costs [ Time Frame: 3 months ]
    cost-effectiveness analysis
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2021)
  • number of correct- and false-positive alerts [ Time Frame: 3 months ]
    definition via comparison of alerts with clinical data
  • number of contacts and hospitalization rates [ Time Frame: 3 months ]
    definition via comparison of alerts and resulting contacts and hospitalization rates with clinical data
  • 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.
  • therapy modifications [ Time Frame: 3 months ]
    dose-reductions (%), postponing of therapy cycles (time in days between actual and plannend date), therapy discontinuation
  • effect on quality of life [ Time Frame: 3 months ]
    change in EORTC QLQ-C30
  • OS; PFS [ Time Frame: 3 months ]
    time between study inclusion and death; time between study inclusion and proven increasing tumor mass (number of days)
  • health-related costs [ Time Frame: 3 months ]
    cost-effectiveness analysis
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Covid-19 Predictors: Safety of Gynecological Oncology Patients Undergoing Chemotherapy
Official Title  ICMJE COVID-19-Prädiktoren: Klinische Studie Zur Sicherheit Von gynäkologisch Onkologischen Patientinnen Unter Chemotherapie - CO-SI-ONKO-Studie
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Telemedicine
Intervention  ICMJE Device: PPG and PROM
description will follow
Study Arms  ICMJE Experimental: Telemedicine
Telemonitoring via PPG (photoplethysmography) and PROM (patient reported outcome monitoring) via app
Intervention: Device: PPG and PROM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2021)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Heike Jansen, Dr. med. +49-89-4140-2420 heike.jansen@tum.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05043220
Other Study ID Numbers  ICMJE CO-SI-ONKO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heike Jansen, Technische Universität München
Study Sponsor  ICMJE Technische Universität München
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Heike Jansen, Dr. med Technische Universität München
Study Director: Marion Kiechle, Prof. Dr. med. Technische Universität München
PRS Account Technische Universität München
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP