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)

Pregnancy Related Clinical Trial

— pIOTA  

Official 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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05974618
• Other study ID #: S66455
• Status: Recruiting
• Start date: June 5, 2023
• Est. completion date: July 2026

Study information

• Verified date: July 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Dirk Timmerman, Professor
• Phone: +3216344201
• Email: dirk.timmerman[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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)

Description:

1. STUDY SUMMARY 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). DESIGN Multicentre, prospective cohort observational study. BACKGROUND Adnexal masses are a common incidental finding in pregnancy. Whilst the majority are benign and resolve spontaneously, a proportion can exhibit suspicious features during pregnancy raising concern about an underlying malignancy. Correct classification of adnexal masses is particularly important during pregnancy given the potential foetal and maternal risks associated with surgical intervention. International Ovarian Tumour Analysis (IOTA) group have developed robust, ultrasound-based tools, including the ADNEX model to support the classification of adnexal masses. Ultrasound-based tools such the Modified Benign Simple Descriptors and ADNEX have been externally validated to aid in the classification of adnexal masses in non-pregnant women, but their use as a robust diagnostic tool in pregnancy remains to be demonstrated. AIMS The principal objective of this study is to prospectively investigate the ability of the ADNEX Model and a 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) to correctly discriminate between benign and malignant adnexal masses diagnosed in pregnancy. PRIMARY OUTCOME MEASURE False discovery rate (number of benign masses / number of masses classified as malignant) when using the ADNEX Model to discriminate between benign and malignant adnexal masses at 11-14 gestational weeks in pregnancy. ELIGIBILITY All women 18 years old and above with an adnexal mass found on ultrasound scan during pregnancy - irrespective of whether the mass known before pregnancy OR diagnosed for the first time on ultrasound scan during pregnancy. DURATION This study will be conducted over a minimum period of three years. KEYWORDS IOTA, ovarian mass, benign, malignant, ultrasound, pregnancy, post-partum

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• 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

Related Conditions & MeSH terms

• Adnexal Mass
• Adnexal Tumor
• Ovarian Neoplasms
• Pregnancy Related

Intervention

Diagnostic Test:
• Ultrasound
A 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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (47)

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* Note: There are 47 references in all — Click here to view all references

Outcome

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)