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

NCT06103916 | Recruiting

• 1 other identifier: N21.105
• Study Type: observational
• Target: 613
• Locations: 1 country
• Sites: 1

Brief 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

Ovarian Tumor; Ovarian Cancer

Keywords

ultrasound; ADNEX model

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy of the IOTA ADNEX model

  Area under the curve (AUC)

  5 years (2022 - 2027)

• Sensitivity and specificity

  Sensitivity and specificity of the IOTA ADNEX model (%) at different thresholds

  5 years (2022 - 2027)

Secondary Outcomes (1)

• Factors influencing the diagnostic performance of the IOTA ADNEX model

  5 years (2022 - 2027)

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women (age ≥ 18 years) presenting with an ovarian tumor that does not meet one of the IOTA criteria of a benign easy descriptor

You may qualify if:

• Age ≥ 18 years
• Presence of a complex ovarian tumor
• Ultrasound assessment in accordance with IOTA definitions and application of the ADNEX model
• Understanding of Dutch language

You may not qualify if:

• Women with an ovarian tumor that meets the IOTA criteria of a benign easy descriptor:
• Unilocular tumor with ground glass echogenicity in premenopausal woman suggestive of endometrioma
• Unilocular tumor with mixed echogenicity and acoustic shadows in premenopausal women (suggestive of benign cystic teratoma)
• Unilocular tumor with regular walls and maximal diameter \< 10cm (suggestive of simple cyst or cystadenoma)
• Remaining unilocular tumors with regular walls
• Histologically proven malignancy prior to ultrasound

Sponsors & Collaborators

• Maxima Medical Center: lead
• Radboud University Medical Center: collaborator
• The Netherlands Cancer Institute: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Máxima Medical Centre

Veldhoven, North Brabant, 5504 DB, Netherlands

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Esther Lems, MD

CONTACT

+31 40 888 83 80; PRIORITY@mmc.nl

Peggy Geomini, PhD

CONTACT

+31 40 888 83 80; PRIORITY@mmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, Principal Investigator

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: October 27, 2023
• Study Start: July 15, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

NL (1)