One Million Cancer Treatment Months
- Conditions
- Cancer
- Registration Number
- NCT04531995
- Lead Sponsor
- Cankado GmbH
- Brief Summary
The OMCAT Register aims to provide learning databases in cancer comprising both PRO data using PRO-React and "ground truth" (outcome data verified by the physician during patient examinations). Intelligent learning and knowledge engineering procedures will utilize this PRO data to provide high-quality event prediction algorithms. The ground-truth data enables so-called "supervised learning" techniques of artificial intelligence, because predicted events can be verified with a high level of certainty from ground-truth data.
- Detailed Description
The next generation of PRO-React by CANKADO is designed to predict impending incident threats at an earlier stage than previously feasible and -- by more timely intervention -- help physicians to eliminate or mitigate the severity of an unfavourable event, reduce the required intensity of countermeasures, or otherwise reduce patient risks.
A highly reliable identification of situations classified as "low-risk" by CANKADO could also enable a more focused utilization of resources as well as enhanced patient comfort and decreased stress, e.g., due to less frequent monitoring visits or reduced need for invasive diagnostics.
The OMCAT Register aims to provide learning databases in cancer comprising both PRO data using PRO-React and "ground truth" (outcome data verified by the physician during patient examinations). Intelligent learning and knowledge engineering procedures will utilize this PRO data to provide high-quality event prediction algorithms. The ground-truth data enables so-called "supervised learning" techniques of artificial intelligence, because predicted events can be verified with a high level of certainty from ground-truth data.
The PRO data of a patient provide what is known in engineering, physics, and statistics as "time series" of observations. The unique feature of PRO time series for applications in cancer is the very high "sampling frequency" (e.g., daily or better) compared to examinations, which generally occur at fixed, and much less frequent intervals. Prediction algorithms based on PRO data would thus be ideally suited to reduce the delay in detecting events, for example, by triggering physician appointments or indicating the need for more intensive medical diagnostics.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 166000
- Signed informed consent
- Age ≥ 18 years
- Diagnosed with cancer
- Prescribed CANKADO PRO-React Onco
- Lack of consent to study participation or lack of patient's ability to consent
- Enrolled in this trial within a further treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Presence or Absence of dosis reductions 6 months yes/no (answered by physician)
Presence or Absence of treatment interruptions 6 months yes/no (answered by physician)
Health Status 6 months Using the EuroQol-visual analogue scale, abbreviated as EQ-VAS Scale, containing values between 100 (best imaginable health) and 0 (worst imaginable health), (answered by patients)
Presence or Absence of death 6 months yes/no (answered by physician)
Complaints/Symptoms 6 months Assessed using a question set aligned with the PRO-CTCAE and CTCAE (answered by patients)
Presence or Absence of SAEs 6 months yes/no (answered by physician)
Presence or Absence of disease progression 6 months yes/no (answered by physician)
Presence or Absence of disease regression 6 months yes/no (answered by physician)
- Secondary Outcome Measures
Name Time Method Patient Typology 6 months According to Bloem et al (PMID: 32771005)
Timepoints of patient documentation 6 months The timepoints at which a patient uses the CANKADO System to document patient-reported outcomes are retrieved from the system including date and time
Cancer type 6 months according to ICD classification
Frequency of patient documentation 6 months The frequency at which a patient uses the CANKADO System to document patient-reported outcomes are calculated using the timepoints of patient documentation
Trial Locations
- Locations (4)
Ev. Krankenhaus Bethesda Praxis für gynäkologische Onkologie
🇩🇪Mönchengladbach, Germany
Onkologische Praxis Moers
🇩🇪Moers, Germany
Schwerpunktpraxis für Hämatologie und Onkologie
🇩🇪Soest, Germany
Hämatologisch-Onkologische Schwerpunktpraxis - Novum medicum
🇩🇪Würzburg, Germany