Pregnancy Related Clinical Trial
— pIOTAOfficial title:
Prospective Validation of the ADNEX Model for Discrimination Between Benign and Malignant Adnexal Masses in Pregnancy: the International Ovarian Tumour Analysis in Pregnancy Study (p-IOTA).
NCT number | NCT05974618 |
Other study ID # | S66455 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 5, 2023 |
Est. completion date | July 2026 |
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)
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | July 2026 |
Est. primary completion date | July 2026 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - • 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. Exclusion Criteria: - • 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. - Age < 18 years |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven |
Belgium,
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* Note: There are 47 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in the ultrasound appearance of endometriomas during gestation; | Change in the ultrasound appearance of endometriomas during gestation; | outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment) | |
Other | - 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). | outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment) | |
Other | - Comparison of the performance of ADNEX with CA125 and that of ADNEX without CA125. | (Specificity, Sensitivity, C-index, Calibration, Clinical Utility) | outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment) | |
Primary | - 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. | outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment) | |
Secondary | - 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. | outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment) | |
Secondary | - 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; | outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment) | |
Secondary | 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 | outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment) | |
Secondary | 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) | outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment) | |
Secondary | 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. | (Calibration) | outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment) | |
Secondary | 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. | (Clinical utility) Net benefit. | outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment) | |
Secondary | 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 any time point in pregnancy. | (C-index) | outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment) | |
Secondary | 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 any time point in pregnancy. | (Sensitivity, Specificity) | outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment) | |
Secondary | 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 any time point in pregnancy. | (Calibration) | outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment) | |
Secondary | 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 any time point in pregnancy. | (Clinical utility) Net benefit. | outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment) | |
Secondary | - Estimation of the ability of the ADNEX model and the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at any time po | - Estimation of the ability of the ADNEX model and the 2-step strategy (sensitivity, specificity, C-index, calibration intercept, calibration slope, clinical utility) to discriminate between benign and malignant adnexal masses when detected at any time point in pregnancy; | outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment) | |
Secondary | Evaluation of change in morphology of ovarian masses throughout pregnancy based on subjective assessment; | Evaluation of change in morphology of ovarian masses throughout pregnancy based on subjective assessment; | outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment) | |
Secondary | Evaluation of change throughout pregnancy and postpartum in papillations based on subjective assessment. | Number, size (mm), colour score (1-4), and morphology. | outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment) |
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