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Prospective Validation and Comparison of Different Ultrasound Methods for Discrimination Between Benign and Malignant Ovarian/Tubal Masses Prior to Surgery

NCT02847832 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1700

Last updated 2020-04-14

No results posted yet for this study

Summary

The ability of different methods to discriminate between benign and malignant adnexal masses has been compared in a meta-analysis showing that the IOTA Simple Rules and the IOTA logistic regression model LR2 were superior to RMI and to all other methods for predicting malignancy in an adnexal mass included in the meta-analysis. However, a fair comparison of methods requires them to be applied on the same tumor population.

The general objective of this study is to prospectively validate the Simple Rules, ADNEX, the Simple Rules risk model, LR2, and RMI on a large multicenter dataset to allow direct comparison of these tools.

IOTA7 is an international multicenter prospective observational study including different types of ultrasound centers and examiners with different levels of ultrasound experience. In total, about 1700 adnexal masses with histological outcome will be included in IOTA 7.

Conditions

  • Patients With Adnexal Mass Prior to Surgery

Interventions

OTHER

Standardized transvaginal ultrasound examination

Sponsors & Collaborators

  • KU Leuven

    lead OTHER

Principal Investigators

  • Tom Bourne, MD, PhD · Queen Charlotte's & Chelsea Hospital, Imperial College London, London, UNITED KINGDOM

  • Ben Van Calster, MSc, PhD · Department Development & Regeneration, KU Leuven, Leuven, BELGIUM

  • Ignace Vergote, MD, PhD · Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, BELGIUM

  • Lil Valentin, MD, PhD · Department of Obstetrics and Gynecology, Skåne University Hospital, Malmö, SWEDEN

  • Antonia C Testa, MD, PhD · Unità Operativa di Ginecologia Oncologica Dipartimento Tutela della Salute della Donna e della Vita Nascente, Università Cattolica di Sacro Cuore, Roma, ITALY

  • Sabine Van Huffel, MSc, PhD · Department of electrical engineering (ESAT SCD-SISTA), KU Leuven, Heverlee-Leuven, BELGIUM

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Belgium

Study Locations

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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 NCT02847832 on ClinicalTrials.gov