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Prospective RegIstration Of the peRformance of the IoTa ADNEX Model in Dutch gYnaecological Practice

NCT06103916 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 613

Last updated 2023-10-27

No results posted yet for this study

Summary

Multicenter prospective cohort study in which patients ≥18 years with an ovarian tumor for which an ultrasound has been performed in accordance with IOTA criteria and the IOTA ADNEX model has been applied are included. Ultrasound data from these patients will be prospectively recorded in a database to determine the diagnostic accuracy of the IOTA ADNEX model in Dutch gynaecological practice.

Conditions

Interventions

OTHER

Observational study. Prospective registration of ultrasound data in patients with ovarian tumors for which an ultrasound in according with the IOTA definitions is performed.

From all included patients, prospective data will be collected of the ultrasound(s) performed, the performed treatment and in case of surgery also the final pathological diagnosis. Participating patients will not be subjected to acts or additional procedures or examinations in this study, nor will rules of conduct be imposed.

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Catharina Ziekenhuis Eindhoven

    collaborator OTHER

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Maxima Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2027-08-31
Completion
2028-05-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06103916 on ClinicalTrials.gov