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One Million Cancer Treatment Months (OMCAT)

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ClinicalTrials.gov Identifier: NCT04531995
Recruitment Status : Recruiting
First Posted : August 31, 2020
Last Update Posted : September 27, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cancer Device: CANKADO PRO-React Onco

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 166000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Development of an Artificial Intelligence-based Incident Prediction Algorithm to Improve Cancer Patient Care and Patient Safety
Actual Study Start Date : August 3, 2022
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Intervention Details:
  • Device: CANKADO PRO-React Onco
    CANKADO PRO-React Onco is approved as class I medical device within the European Union (registration number DE /CA59 /371/2020-R/Hd) and is compliant with the FDA classification for Mobile Medical Devices (2015) Appendix B. The purpose of CANKADO PRO-React Onco is to be an automated digital support for patients to help them decide how urgent it is to contact the attending physician based on the symptoms they independently record in the system. It supports patients with cancer under systemic, anti-tumor or anti-hormonal therapy in adjuvant, neoadjuvant, post-neoadjuvant or palliative situations. It is unsuitable for patients undergoing radiotherapy, cell and gene therapy, surgical procedures or alternative healing methods.


Primary Outcome Measures :
  1. Health Status [ Time Frame: 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)

  2. Complaints/Symptoms [ Time Frame: 6 months ]
    Assessed using a question set aligned with the PRO-CTCAE and CTCAE (answered by patients)

  3. Presence or Absence of SAEs [ Time Frame: 6 months ]
    yes/no (answered by physician)

  4. Presence or Absence of dosis reductions [ Time Frame: 6 months ]
    yes/no (answered by physician)

  5. Presence or Absence of treatment interruptions [ Time Frame: 6 months ]
    yes/no (answered by physician)

  6. Presence or Absence of disease progression [ Time Frame: 6 months ]
    yes/no (answered by physician)

  7. Presence or Absence of disease regression [ Time Frame: 6 months ]
    yes/no (answered by physician)

  8. Presence or Absence of death [ Time Frame: 6 months ]
    yes/no (answered by physician)


Secondary Outcome Measures :
  1. Cancer type [ Time Frame: 6 months ]
    according to ICD classification

  2. Patient Typology [ Time Frame: 6 months ]
    According to Bloem et al (PMID: 32771005)

  3. Timepoints of patient documentation [ Time Frame: 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

  4. Frequency of patient documentation [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer Patients under systemic, anti-tumor or anti-hormonal therapy in adjuvant, neoadjuvant, post-neoadjuvant or palliative situations with prescribed CANKADO PRO-React Onco will be enrolled.
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Age ≥ 18 years
  • Diagnosed with cancer
  • Prescribed CANKADO PRO-React Onco

Exclusion Criteria:

  • Lack of consent to study participation or lack of patient's ability to consent
  • Enrolled in this trial within a further treatment

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): NCT04531995


Contacts
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Contact: Christian Tonk, MSc. +4922142915300 c.tonk@cankado.com

Locations
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Germany
Onkologische Praxis Moers Recruiting
Moers, Germany, 47441
Ev. Krankenhaus Bethesda Praxis für gynäkologische Onkologie Not yet recruiting
Mönchengladbach, Germany, 41061
Schwerpunktpraxis für Hämatologie und Onkologie Recruiting
Soest, Germany, 59494
Hämatologisch-Onkologische Schwerpunktpraxis - Novum medicum Recruiting
Würzburg, Germany, 97080
Sponsors and Collaborators
Cankado GmbH
Investigators
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Study Director: Timo Schinköthe, PhD Cankado GmbH
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Responsible Party: Cankado GmbH
ClinicalTrials.gov Identifier: NCT04531995    
Other Study ID Numbers: CAN-20-01
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: September 27, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cankado GmbH:
Artificial Intelligence