NCT04531995

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
166,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

August 3, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

3.3 years

First QC Date

August 21, 2020

Last Update Submit

September 26, 2022

Conditions

Cancer

Keywords

Artificial Intelligence

Outcome Measures

Primary Outcomes (8)

  • 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)

    6 months

  • Complaints/Symptoms

    Assessed using a question set aligned with the PRO-CTCAE and CTCAE (answered by patients)

    6 months

  • Presence or Absence of SAEs

    yes/no (answered by physician)

    6 months

  • Presence or Absence of dosis reductions

    yes/no (answered by physician)

    6 months

  • Presence or Absence of treatment interruptions

    yes/no (answered by physician)

    6 months

  • Presence or Absence of disease progression

    yes/no (answered by physician)

    6 months

  • Presence or Absence of disease regression

    yes/no (answered by physician)

    6 months

  • Presence or Absence of death

    yes/no (answered by physician)

    6 months

Secondary Outcomes (4)

  • Cancer type

    6 months

  • Patient Typology

    6 months

  • Timepoints of patient documentation

    6 months

  • Frequency of patient documentation

    6 months

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Onkologische Praxis Moers

Moers, 47441, Germany

RECRUITING

Ev. Krankenhaus Bethesda Praxis für gynäkologische Onkologie

Mönchengladbach, 41061, Germany

NOT YET RECRUITING

Schwerpunktpraxis für Hämatologie und Onkologie

Soest, 59494, Germany

RECRUITING

Hämatologisch-Onkologische Schwerpunktpraxis - Novum medicum

Würzburg, 97080, Germany

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Timo Schinköthe, PhD

    Cankado GmbH

    STUDY DIRECTOR

Central Study Contacts

Christian Tonk, MSc.

CONTACT

+4922142915300c.tonk@cankado.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2020

First Posted

August 31, 2020

Study Start

August 3, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

September 27, 2022

Record last verified: 2022-09

Locations

DE(4)