CancerOMCATNCT04531995
One Million Cancer Treatment Months
An observational study of Cancer, run by Cankado GmbH at 4 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- CANKADO PRO-React Onco
- Type of treatment
- Medical device
- How many people
- 166,000 participants
- Where
- 4 sitesGermany
- Study dates
- 3 Aug 2022to Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Signed informed consent
- Age ≥ 18 years
- Diagnosed with cancer
- Prescribed CANKADO PRO-React Onco
Who cannot join
- Lack of consent to study participation or lack of patient's ability to consent
- Enrolled in this trial within a further treatment
Trial locations and contacts
4 sites in 1 country.
Germany4 sites, 4 recruiting
- Recruiting
Onkologische Praxis Moers
Moers, 47441
- Not yet recruiting
Ev. Krankenhaus Bethesda Praxis für gynäkologische Onkologie
Mönchengladbach, 41061
- Recruiting
Schwerpunktpraxis für Hämatologie und Onkologie
Soest, 59494
- Recruiting
Hämatologisch-Onkologische Schwerpunktpraxis - Novum medicum
Würzburg, 97080
About this study
Official title: Development of an Artificial Intelligence-based Incident Prediction Algorithm to Improve Cancer Patient Care and Patient Safety
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- CANKADO PRO-React Onco
- Keywords
- Artificial Intelligence
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CANKADO PRO-React OncoDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Status
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)
Measured: 6 months
Complaints/Symptoms
Assessed using a question set aligned with the PRO-CTCAE and CTCAE (answered by patients)
Measured: 6 months
Presence or Absence of SAEs
yes/no (answered by physician)
Measured: 6 months
Presence or Absence of dosis reductions
yes/no (answered by physician)
Measured: 6 months
Presence or Absence of treatment interruptions
yes/no (answered by physician)
Measured: 6 months
Presence or Absence of disease progression
yes/no (answered by physician)
Measured: 6 months
Presence or Absence of disease regression
yes/no (answered by physician)
Measured: 6 months
Presence or Absence of death
yes/no (answered by physician)
Measured: 6 months
Secondary outcomes (4)
Cancer type
according to ICD classification
Measured: 6 months
Patient Typology
According to Bloem et al (PMID: 32771005)
Measured: 6 months
Timepoints of patient documentation
The timepoints at which a patient uses the CANKADO System to document patient-reported outcomes are retrieved from the system including date and time
Measured: 6 months
Frequency of patient documentation
The frequency at which a patient uses the CANKADO System to document patient-reported outcomes are calculated using the timepoints of patient documentation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start3 Aug 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Cankado GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timo Schinköthe, PhD, Study director, Cankado GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531995
- Sponsor's protocol ID
- CAN-20-01
- Acronym
- OMCAT
- Status last verified
- Sep 2022
- First submitted
- 21 Aug 2020
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Artificial Intelligence-based Incident Prediction Algorithm to Improve Cancer Patient Care and Patient Safety
- ClinicalTrials.gov ID
- NCT04531995
- Acronym / sponsor ID
- OMCAT / CAN-20-01
- Conditions
- Cancer
- Keywords
- Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 166,000 participants (estimated)
- Lead sponsor
- Cankado GmbHIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Signed informed consent
- Age ≥ 18 years
- Diagnosed with cancer
- Prescribed CANKADO PRO-React Onco
Key exclusion criteria (2 listed)
- Lack of consent to study participation or lack of patient's ability to consent
- Enrolled in this trial within a further treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CANKADO PRO-React OncoCANKADO 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. | Device | – |
Primary outcome
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)
Complaints/Symptoms
Time frame: 6 months
Assessed using a question set aligned with the PRO-CTCAE and CTCAE (answered by patients)
Presence or Absence of SAEs
Time frame: 6 months
yes/no (answered by physician)
Presence or Absence of dosis reductions
Time frame: 6 months
yes/no (answered by physician)
Presence or Absence of treatment interruptions
Time frame: 6 months
yes/no (answered by physician)
Presence or Absence of disease progression
Time frame: 6 months
yes/no (answered by physician)
Presence or Absence of disease regression
Time frame: 6 months
yes/no (answered by physician)
Presence or Absence of death
Time frame: 6 months
yes/no (answered by physician)
4 secondary outcomes
Cancer type
Time frame: 6 months
Patient Typology
Time frame: 6 months
Timepoints of patient documentation
Time frame: 6 months
Frequency of patient documentation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timo Schinköthe, PhD study director
Cankado GmbH
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Cankado GmbH at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Tonk, MSc. (+4922142915300, c.tonk@cankado.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Status (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.