Adnexal MassMY-IOTANCT06693596
Masses in Young Patients - International Ovarian Tumour Analysis (MY-IOTA)
An observational study of Adnexal Mass and Adnexal Tumor, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This multicenter observational study aims to validate the IOTA Simple Rules, Benign Descriptors, and ADNEX model in a cohort of patients equal or under the age of 20. Moreover, the study aims to evaluate the diagnostic accuracy of subjective assessment by ultrasound and to analyze the rate of complications in patients… Read more about this study
- Who is it for?
- Ages 0 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adnexal Mass, Adnexal Tumor, Adnexal Cyst
- What is being tested?
- Group 2: Conservative management (follow-up) and Group 1: Surgical management
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Nov 2024to 30 Sep 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Patients under 18 years of age newly diagnosed with adnexal masses in the study centre (UZ Leuven) or in one of the other affiliated hospitals and who underwent both conservative and surgical management.
- Inclusion Criteria:
All newly diagnosed adnexal masses identified in a girl or adolescent aged 20 or under.
- Exclusion Criteria:
Participants eligible for this study must not meet any of the following criteria:
- Non-adnexal masses e.g. peritoneal inclusion cysts (where diagnosis is certain) and peritoneal carcinomatosis with no adnexal mass;
- The denial or withdrawal of written informed consent.
- Pregnancy at any timepoint during the study period
- In premenarchal participants: follicle measuring <10mm
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Dirk Timmerman, 3216344202, iota@uzleuven.be
About this study
Official title: Masses in Young Patients - International Ovarian Tumour Analysis: Prospective Validation and Comparison of Simple Rules, Benign Descriptors and ADNEX Models for Discrimination Between Benign and Malignant Adnexal Masses in Young Girls and Adolescents MY-IOTA
This multicenter observational study aims to validate the IOTA Simple Rules, Benign Descriptors, and ADNEX model in a cohort of patients equal or under the age of 20. Moreover, the study aims to evaluate the diagnostic accuracy of subjective assessment by ultrasound and to analyze the rate of complications in patients treated conservatively.
Read the detailed description
Ovarian masses are uncommon in children, with an estimated annual incidence of 2.6/100,000. They are most identified in the neonatal period or around the time of menarche. Most ovarian cysts are benign and 55-70% of which are mature cystic teratomas. In most cases, patients are asymptomatic and the ovarian lesions are incidentally detected through ultrasound examinations. However, up to 15% of cases may involve abdominal pain and torsion. Furthermore, despite the low incidence of ovarian cancer (less than 1% of all pediatric cancers), the possibility of malignant tumor must be addressed.
In 2018, a national survey of pediatric surgeons in the UK revealed significant variability in the strategies employed for investigating and surgically managing adnexal lesions in children and adolescents. Although there is a spread consensus that ultrasound indices are useful for distinguishing between benign and malignant lesions in pediatric patient, the evidence available for this specific population is limited and it lacks comprehensive data from large cohorts. Moreover, existing models developed by the International Ovarian Tumor Analysis (IOTA) group, such as the Simple Rules, Benign Descriptors, and ADNEX model, have not been validated in this younger population. Additionally, it is still unclear if these tools remain validated with a transabdominal approach, primarily used for children and non-sexually active adolescents.
The primary objective of this prospective study is therefore to assess the performance of these existing ultrasonography-based risk tools in discriminating between benign and malignant adnexal masses in neonates, young girls and adolescents using transabdominal and/or transvaginal ultrasound.
Secondary aims are the diagnostic accuracy of subjective assessment by ultrasound, the understanding of the natural history of adnexal masses at 6-8 weeks, 3 months, and 12 months and the assessment of the complications rate (such as rupture, torsion, or malignancy) in patients treated conservatively.
Final outcome will be based on pathology in patients who undergo surgery and on pattern recognition, i.e. subjective assessment of ultrasound examiner, in patients managed conservatively for masses where morphology remains unchanged during follow-up.
The study will be conducted over a minimum of two years. We anticipate recruiting 1000 surgically managed masses over a 24-month period.
- Being tested
- Group 2: Conservative management (follow-up), Group 1: Surgical management
- Keywords
- IOTA, ovarian mass, benign, malignant, Young patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 2: Conservative management (follow-up)Diagnostic test
Also called Ultrasound Assessment
A standardised transabdominal examination is performed, including color or power Doppler examination. Transvaginal ultrasonography can be performed in sexually active adolescents with consent. Transrectal examination is also acceptable for younger patients who are not sexually active. All the variables required for the Simple Rules, simple descriptors and ADNEX model are assessed.
Before entering ultrasound information about the tumour and getting model results, the ultrasound examiner' s diagnosis (benign, borderline, malignant; specific diagnosis) based on subjective assessment is recorded. Results based on Simple Rules, simple descriptors and ADNEX model are documented as well.
If the adnexal mass is seen and if the decision is to manage the adnexal mass conservatively, the patient will be re-scanned at 6 weeks (maximal range 6-8 weeks), 3 months (+/- 2 weeks) and 12 months (maximal range 10-14 months)
Group 1: Surgical managementProcedure or surgery
Also called Surgery
A standardised transabdominal examination is performed, including color or power Doppler examination. Transvaginal ultrasonography can be performed in sexually active adolescents with consent. Transrectal examination is also acceptable for younger patients who are not sexually active. All the variables required for the Simple Rules, simple descriptors and ADNEX model are assessed.
Before entering ultrasound information about the tumour and getting model results, the ultrasound examiner' s diagnosis (benign, borderline, malignant; specific diagnosis) based on subjective assessment is recorded. Results based on Simple Rules, simple descriptors and ADNEX model are documented as well.
If the patient requires surgery, no further ultrasound scans will be required.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Surgical management | Patients aged ≤ 20 years of age recommended for surgery at that visit due to a suspicion of malignancy or pain. Receives: Procedure: Group 1: Surgical management | |
| Group 2: Conservative management (follow-up) | Patients aged ≤ 20 not recommended for surgery due to suspicion of malignancy/complications, for which subjective impression was benign for all visits, and for which the tumour was still present at the next visit. Receives: Diagnostic Test: Group 2: Conservative management (follow-up) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the ability of the ADNEX model without CA125 to discriminate between benign and malignant adnexal masses when detected in patients aged 20 or under (AUC)
Area under the receiver operating characteristic curve (AUC). This will be done using the estimated probability of malignancy, which equals 1 minus the estimated probability of a benign tumor. 95% confidence intervals provided. Analysis will be done twice: for subgroup 1 and for subgroups 1 and 2 combined.
Measured: Outcome based on histology for group 1 assessed at 12 months after recruitment or no sign of malignancy during the ultrasound follow-up for group 2 assessed up to 12 months after recruitment.
Estimation of the ability of the ADNEX model and subjective assessment to classify adnexal masses as benign or malignant when detected in patients aged 20 or under (Sensitivity, Specificity, positive predictive value, and negative predictive value)
Sensitivity, Specificity, positive predictive value, and negative predictive value. Providing 95% confidence intervals and ,for ADNEX, Using several cut-offs on the risk of malignancy. Analysis will be done twice: for subgroup 1 and for subgroups 1 and 2 combined.
Measured: Outcome based on histology for group 1 or follow-up for group 2 (maximum 12 months after recruitment)
Estimation of the ability of the ADNEX model to predict individual risk of malignancy of adnexal masses when detected in patients aged 20 or under (Calibration)
O:E ratio, and generate a flexible calibration curve. Analysis will be done twice: for subgroup 1 and for subgroups 1 and 2 combined.
Measured: Outcome based on histology for group 1 or follow-up for group 2 (maximum 12 months after recruitment)
Estimation of the ability of the Benign Descriptors to detect malignancies in patients aged 20 or under.
Number and percentage of patients that fit any BD, only BD1, only BD2, only BD3, and only BD4 and percentage of malignancies among patients that fit any BD, only BD1, only BD2, only BD3, only BD4. We provide 95% confidence intervals for every result.
Measured: Outcome based on histology for group 1 or follow-up for group 2 (maximum 12 months after recruitment)
Estimation of the ability of the ADNEX model without CA125 to discriminate between benign and malignant adnexal masses when detected in patients aged 20 or under (AUC)
Area under the receiver operating characteristic curve (AUC). This will be done using the estimated probability of malignancy, which equals 1 minus the estimated probability of a benign tumor. 95% confidence intervals provided. Analysis will be done twice: for subgroup 1 and for subgroups 1 and 2 combined.
Measured: Outcome based on histology for group 1 or follow-up for group 2 (maximum 12 months after recruitment)
Secondary outcomes (2)
Occurrence of complications during follow up.
We calculated the follow-up time from the recruitment visit until surgery, spontaneous resolution or death. If none of these events was observed, follow-up time was censored at the time of the last visit. We constructed cumulative incidence curves, considering the competing risk setting (three possible events). We report the estimated cumulative incidence of each event (with 95% confidence intervals) at 3 and 12 months of follow-up.
Measured: The occurrence of complications will be reported at two specific time points: at 3 months and 12 months after recruitment.
Examination of natural history
We will describe ultrasound characteristics (median, IQR and range for continuous variables, frequency and proportion for categorical variables) at every visit (initial visit, 6-8 week visit, 3 month visit, 12 month visit).
This will be done overall and separately for three subgroups.
- Patients in group 1. It does not matter whether surgery eventually took place or not.
- Patients in group 2, and for which the mass has spontaneously resolved at the next visit (this subgroup is not applicable at the 12 month visit).
- Patients in group 2 (this subgroup is not applicable at the 12 month visit) Exceptions: decision to operate, but it did not happen; LFU after that visit.
Measured: Initial visit, 6-8 week visit, 3-month visit, and 12-month visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start20 Nov 2024 (estimated)
- Primary completion21 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adnexal MassStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693596
- Sponsor's protocol ID
- S68104
- Acronym
- MY-IOTA
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Masses in Young Patients - International Ovarian Tumour Analysis: Prospective Validation and Comparison of Simple Rules, Benign Descriptors and ADNEX Models for Discrimination Between Benign and Malignant Adnexal Masses in Young Girls and Adolescents MY-IOTA
- ClinicalTrials.gov ID
- NCT06693596
- Acronym / sponsor ID
- MY-IOTA / S68104
- Keywords
- IOTA, ovarian mass, benign, malignant, Young patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 21 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter observational study aims to validate the IOTA Simple Rules, Benign Descriptors, and ADNEX model in a cohort of patients equal or under the age of 20. Moreover, the study aims to evaluate the diagnostic accuracy of subjective assessment by ultrasound and to analyze the rate of complications in patients treated conservatively.
Detailed description
Ovarian masses are uncommon in children, with an estimated annual incidence of 2.6/100,000. They are most identified in the neonatal period or around the time of menarche. Most ovarian cysts are benign and 55-70% of which are mature cystic teratomas. In most cases, patients are asymptomatic and the ovarian lesions are incidentally detected through ultrasound examinations. However, up to 15% of cases may involve abdominal pain and torsion. Furthermore, despite the low incidence of ovarian cancer (less than 1% of all pediatric cancers), the possibility of malignant tumor must be addressed.
In 2018, a national survey of pediatric surgeons in the UK revealed significant variability in the strategies employed for investigating and surgically managing adnexal lesions in children and adolescents. Although there is a spread consensus that ultrasound indices are useful for distinguishing between benign and malignant lesions in pediatric patient, the evidence available for this specific population is limited and it lacks comprehensive data from large cohorts. Moreover, existing models developed by the International Ovarian Tumor Analysis (IOTA) group, such as the Simple Rules, Benign Descriptors, and ADNEX model, have not been validated in this younger population. Additionally, it is still unclear if these tools remain validated with a transabdominal approach, primarily used for children and non-sexually active adolescents.
The primary objective of this prospective study is therefore to assess the performance of these existing ultrasonography-based risk tools in discriminating between benign and malignant adnexal masses in neonates, young girls and adolescents using transabdominal and/or transvaginal ultrasound.
Secondary aims are the diagnostic accuracy of subjective assessment by ultrasound, the understanding of the natural history of adnexal masses at 6-8 weeks, 3 months, and 12 months and the assessment of the complications rate (such as rupture, torsion, or malignancy) in patients treated conservatively.
Final outcome will be based on pathology in patients who undergo surgery and on pattern recognition, i.e. subjective assessment of ultrasound examiner, in patients managed conservatively for masses where morphology remains unchanged during follow-up.
The study will be conducted over a minimum of two years. We anticipate recruiting 1000 surgically managed masses over a 24-month period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Surgical management | – | Procedure: Group 1: Surgical managementPatients aged ≤ 20 years of age recommended for surgery at that visit due to a suspicion of malignancy or pain. |
| Group 2: Conservative management (follow-up) | – | Diagnostic Test: Group 2: Conservative management (follow-up)Patients aged ≤ 20 not recommended for surgery due to suspicion of malignancy/complications, for which subjective impression was benign for all visits, and for which the tumour was still present at the next visit. |
Who may qualify
- Ages
- 0 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients under 18 years of age newly diagnosed with adnexal masses in the study centre (UZ Leuven) or in one of the other affiliated hospitals and who underwent both conservative and surgical management.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 2: Conservative management (follow-up)Also: Ultrasound AssessmentA standardised transabdominal examination is performed, including color or power Doppler examination. Transvaginal ultrasonography can be performed in sexually active adolescents with consent. Transrectal examination is also acceptable for younger patients who are not sexually active. All the variables required for the Simple Rules, simple descriptors and ADNEX model are assessed. Before entering ultrasound information about the tumour and getting model results, the ultrasound examiner' s diagnosis (benign, borderline, malignant; specific diagnosis) based on subjective assessment is recorded. Results based on Simple Rules, simple descriptors and ADNEX model are documented as well. If the adnexal mass is seen and if the decision is to manage the adnexal mass conservatively, the patient will be re-scanned at 6 weeks (maximal range 6-8 weeks), 3 months (+/- 2 weeks) and 12 months (maximal range 10-14 months) | Diagnostic test | Group 2: Conservative management (follow-up) |
| Group 1: Surgical managementAlso: SurgeryA standardised transabdominal examination is performed, including color or power Doppler examination. Transvaginal ultrasonography can be performed in sexually active adolescents with consent. Transrectal examination is also acceptable for younger patients who are not sexually active. All the variables required for the Simple Rules, simple descriptors and ADNEX model are assessed. Before entering ultrasound information about the tumour and getting model results, the ultrasound examiner' s diagnosis (benign, borderline, malignant; specific diagnosis) based on subjective assessment is recorded. Results based on Simple Rules, simple descriptors and ADNEX model are documented as well. If the patient requires surgery, no further ultrasound scans will be required. | Procedure or surgery | Group 1: Surgical management |
Primary outcome
Estimation of the ability of the ADNEX model without CA125 to discriminate between benign and malignant adnexal masses when detected in patients aged 20 or under (AUC)
Time frame: Outcome based on histology for group 1 assessed at 12 months after recruitment or no sign of malignancy during the ultrasound follow-up for group 2 assessed up to 12 months after recruitment.
Area under the receiver operating characteristic curve (AUC). This will be done using the estimated probability of malignancy, which equals 1 minus the estimated probability of a benign tumor. 95% confidence intervals provided. Analysis will be done twice: for subgroup 1 and for subgroups 1 and 2 combined.
Estimation of the ability of the ADNEX model and subjective assessment to classify adnexal masses as benign or malignant when detected in patients aged 20 or under (Sensitivity, Specificity, positive predictive value, and negative predictive value)
Time frame: Outcome based on histology for group 1 or follow-up for group 2 (maximum 12 months after recruitment)
Sensitivity, Specificity, positive predictive value, and negative predictive value. Providing 95% confidence intervals and ,for ADNEX, Using several cut-offs on the risk of malignancy. Analysis will be done twice: for subgroup 1 and for subgroups 1 and 2 combined.
Estimation of the ability of the ADNEX model to predict individual risk of malignancy of adnexal masses when detected in patients aged 20 or under (Calibration)
Time frame: Outcome based on histology for group 1 or follow-up for group 2 (maximum 12 months after recruitment)
O:E ratio, and generate a flexible calibration curve. Analysis will be done twice: for subgroup 1 and for subgroups 1 and 2 combined.
Estimation of the ability of the Benign Descriptors to detect malignancies in patients aged 20 or under.
Time frame: Outcome based on histology for group 1 or follow-up for group 2 (maximum 12 months after recruitment)
Number and percentage of patients that fit any BD, only BD1, only BD2, only BD3, and only BD4 and percentage of malignancies among patients that fit any BD, only BD1, only BD2, only BD3, only BD4. We provide 95% confidence intervals for every result.
Estimation of the ability of the ADNEX model without CA125 to discriminate between benign and malignant adnexal masses when detected in patients aged 20 or under (AUC)
Time frame: Outcome based on histology for group 1 or follow-up for group 2 (maximum 12 months after recruitment)
Area under the receiver operating characteristic curve (AUC). This will be done using the estimated probability of malignancy, which equals 1 minus the estimated probability of a benign tumor. 95% confidence intervals provided. Analysis will be done twice: for subgroup 1 and for subgroups 1 and 2 combined.
2 secondary outcomes
Occurrence of complications during follow up.
Time frame: The occurrence of complications will be reported at two specific time points: at 3 months and 12 months after recruitment.
Examination of natural history
Time frame: Initial visit, 6-8 week visit, 3-month visit, and 12-month visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adnexal Mass and Adnexal Tumor, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dirk Timmerman, Prof. (+3216344202, iota@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the ability of the ADNEX model without CA125 to discriminate between benign and malignant adnexal masses when detected in patients aged 20 or under (AUC) (time frame: Outcome based on histology for group 1 assessed at 12 months after recruitment or no sign of malignancy during the ultrasound follow-up for group 2 assessed up to 12 months after recruitment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.