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)

Trial Title: 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)

NCT ID: NCT05974618

Condition: Adnexal Mass
Adnexal Tumor
Adnexal Cyst
Pregnancy Related

Conditions: Official terms:
Ovarian Neoplasms

Conditions: Keywords:
IOTA
ovarian mass
pregnancy
ultrasound
post-partum
benign
malignant

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Ultrasound
Description: 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.
Arm group label: First arm (primary objective):
Arm group label: Second arm (secondary objective):
Arm group label: Third arm (secondary objective):

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)

Detailed 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

Criteria for eligibility:

Study pop:
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.

Sampling method: Probability Sample
Criteria:
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

Gender: Female

Minimum age: 18 Years

Maximum age: 50 Years

Locations:

Facility:
Name: UZ Leuven

Address:
City: Leuven
Zip: 3000
Country: Belgium

Status: Recruiting

Contact:
Last name: Dirk Timmerman, Professor

Phone: +3216344201
Email: dirk.timmerman@uzleuven.be

Start date: June 5, 2023

Completion date: July 2026

Lead sponsor:
Agency: Universitaire Ziekenhuizen KU Leuven
Agency class: Other

Source: Universitaire Ziekenhuizen KU Leuven

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05974618