Masses in Young Patients - International Ovarian Tumour Analysis (MY-IOTA)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age0-20
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Group 2: Conservative management (follow-up)
Diagnostic testA 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 management
Procedure/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.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Group 1: Surgical management1 intervention
Group B: Group 2: Conservative management (follow-up)1 intervention
Trial outcomes
Primary outcomes
1
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.
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.2
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.
Time frame
Outcome based on histology for group 1 or follow-up for group 2 (maximum 12 months after recruitment)3
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.
Time frame
Outcome based on histology for group 1 or follow-up for group 2 (maximum 12 months after recruitment)4
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.
Time frame
Outcome based on histology for group 1 or follow-up for group 2 (maximum 12 months after recruitment)Secondary outcomes
1
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.
Time frame
The occurrence of complications will be reported at two specific time points: at 3 months and 12 months after recruitment.2
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.
Time frame
Initial visit, 6-8 week visit, 3-month visit, and 12-month visit.Sponsors and contacts
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Source ClinicalTrials.gov