Prospective Validation of the ADNEX Model for discrimination between benign and malignant adnexal masses in pregnancy:
International Ovarian Tumour Analysis in pregnancy study (p-IOTA)
• Consecutive patients with non-physiological adnexal masses or physiological cysts measuring 5cm or more in largest dimension;
In case of more than one mass seen, only most suspicious mass to be included OR in case of two similar masses, the one with the largest dimension or most easily accessible with ultrasound;
Previously recruited patient presenting with a different mass in subsequent pregnancy;
Age 18 years and above.
• Cysts deemed to be clearly physiological WHEN smaller than 5 cm (largest diameter);
Non-adnexal masses, e.g. peritoneal inclusion cysts (when diagnosis is certain) and peritoneal carcinomatosis with no adnexal mass;
The denial or withdrawal of written informed consent;
Same cyst already recruited for p-IOTA in a previous pregnancy.
Our sample population will come from Early Pregnancy Units and from Tertiary referral centres for ultrasound with or without an oncology department attached to it. The sample size estimation is based on data from Tertiary referral centres.
Cohort
Prospective
Ultrasound
Diagnostic testA standardised transvaginal (supplemented with transabdominal if transvaginal is not sufficient) examination is performed. When a colour Doppler ultrasound examination is performed, the pulse repetition frequency should be 0.3-0.6 KHz. The colour Doppler gain should be increased until colour Doppler artefacts appear and then lowered until just below the reappearance of colour Doppler artefacts. Ultrasound frequency and "priority" (grey scale or colour/Power Doppler) must also be optimised when using colour/power Doppler. Doppler ultrasound should be used with all masses included, irrespective of gestational age.
- Estimation of the false discovery rate when the ADNEX Model is applied at 11-14 weeks.
\- Estimation of the false discovery rate when the ADNEX Model is applied at 11-14 weeks.
- Estimation of the false discovery rate when the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) is applied at 11-14 weeks.
\- Estimation of the false discovery rate when the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) is applied at 11-14 weeks.
- Estimation of the false discovery rate when the ADNEX Model and the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) are applied at any time point during pregnancy;
\- Estimation of the false discovery rate when the ADNEX Model and the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) are applied at any time point during pregnancy;
Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at 11-14 weeks gestation.
C-index
Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at 11-14 weeks gestation.
(Sensitivity, Specificity)
Change in the ultrasound appearance of endometriomas during gestation;
Change in the ultrasound appearance of endometriomas during gestation;
- Occurrence of complications such as rupture, torsion, or malignancy during pregnancy in patients with conservatively treated masses (cumulative incidence illustrated by 'reverse' Kaplan-Meier curves).
\- Occurrence of complications such as rupture, torsion, or malignancy during pregnancy in patients with conservatively treated masses (cumulative incidence illustrated by 'reverse' Kaplan-Meier curves).
- Comparison of the performance of ADNEX with CA125 and that of ADNEX without CA125.
(Specificity, Sensitivity, C-index, Calibration, Clinical Utility)
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