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Trial Title:
Prospective RegIstration Of the peRformance of the IoTa ADNEX Model in Dutch gYnaecological Practice
NCT ID:
NCT06103916
Condition:
Ovarian Tumor
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Conditions: Keywords:
ultrasound
ADNEX model
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Observational study. Prospective registration of ultrasound data in patients with ovarian tumors for which an ultrasound in according with the IOTA definitions is performed.
Description:
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.
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.
Detailed description:
Rationale: Correct pre-operative classification of ovarian tumors is critical for optimal
treatment of both women with benign and malignant ovarian tumors. The International
Ovarian Tumor Analysis (IOTA) consortium developed several risk-assessment strategies,
including the Assessment of Different NEoplasias in the adneXa (ADNEX) model. This is a
polytomous model that estimates the risk of malignancy in women with an ovarian tumor and
can help differentiate benign from malignant ovarian tumors. Recent validation studies
have shown superior diagnostic accuracy of the ADNEX model compared with previously
developed risk-assessment strategies. However, the diagnostic accuracy of this model in
daily clinical practice is still unknown. Furthermore, expertise is necessary to use this
model before the results are reliable. With the recently published Dutch guideline on
risk-assessment strategies of ovarian tumors, in which it is advised to use the ADNEX
model, clinical data on diagnostic performance of the ADNEX model in daily Dutch
gynaecological practice are necessary. Lower sensitivity and/or specificity of the model
will have significant influence on the referral practice in The Netherlands.
Objective: To determine the diagnostic accuracy of the IOTA ADNEX model in the
discrimination between benign and malignant ovarian tumors in daily gynaecological
practice in The Netherlands.
Study design: Multicentre prospective cohort study. Hospitals from three oncologic
networks in the Netherlands will participate in this trial. Ultrasound data will be
prospectively recorded in a database for a duration of five years by means of an
electronic case report form (eCRF). With these data, the diagnostic accuracy of the IOTA
ADNEX model will be calculated.
Study population: All women ≥ 18 years with an ovarian tumor for which ultrasound
assessment in accordance with the IOTA definitions has been performed and the ADNEX model
has been applied. Women with a tumor that meets the IOTA criteria of a benign 'easy
descriptor' will be excluded.
Data collection: All patients eligible for this study will be asked for informed consent
and clinical data will be collected through eCRFs. Data will be collected in a
cloud-based database by the treating physician.
Main study parameters/endpoints: The sensitivity, specificity and area under the curve of
the IOTA ADNEX model.
Secondary analysis: Secondary endpoints include the influence of practice variation (eg
type of center, volume per center, prevalence of malignancy, availability of consultation
time specifically aimed at performing ultrasounds according to IOTA criteria) and the
experience of the ultrasound performer on the diagnostic accuracy of the IOTA ADNEX
model.
Criteria for eligibility:
Study pop:
Women (age ≥ 18 years) presenting with an ovarian tumor that does not meet one of the
IOTA criteria of a benign easy descriptor
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Presence of a complex ovarian tumor
3. Ultrasound assessment in accordance with IOTA definitions and application of the
ADNEX model
4. Understanding of Dutch language
Exclusion Criteria:
1. Women with an ovarian tumor that meets the IOTA criteria of a benign easy
descriptor:
1. Unilocular tumor with ground glass echogenicity in premenopausal woman
suggestive of endometrioma
2. Unilocular tumor with mixed echogenicity and acoustic shadows in premenopausal
women (suggestive of benign cystic teratoma)
3. Unilocular tumor with regular walls and maximal diameter < 10cm (suggestive of
simple cyst or cystadenoma)
4. Remaining unilocular tumors with regular walls
2. Histologically proven malignancy prior to ultrasound
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Máxima Medical Centre
Address:
City:
Veldhoven
Zip:
5504 DB
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Esther Lems, MD
Phone:
+31408888380
Email:
PRIORITY@mmc.nl
Start date:
July 15, 2022
Completion date:
May 2028
Lead sponsor:
Agency:
Maxima Medical Center
Agency class:
Other
Collaborator:
Agency:
Radboud University Medical Center
Agency class:
Other
Collaborator:
Agency:
The Netherlands Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Catharina Ziekenhuis Eindhoven
Agency class:
Other
Collaborator:
Agency:
ZonMw: The Netherlands Organisation for Health Research and Development
Agency class:
Other
Source:
Maxima Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06103916
