Masses in Young Patients - International Ovarian Tumour Analysis (MY-IOTA)

NCT06693596 | Recruiting

• 1 other identifier: S68104
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adnexal Mass; Adnexal Tumor; Adnexal Cyst; Adnexal Masses in Young Girls and Adolescents

Keywords

IOTA; ovarian mass; benign; malignant; Young patients

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

• 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.

  Outcome based on histology for group 1 or follow-up for group 2 (maximum 12 months after recruitment)

• 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.

  Outcome based on histology for group 1 or follow-up for group 2 (maximum 12 months after recruitment)

• 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.

  Outcome based on histology for group 1 or follow-up for group 2 (maximum 12 months after recruitment)

• 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.

  Outcome based on histology for group 1 or follow-up for group 2 (maximum 12 months after recruitment)

Secondary Outcomes (2)

• Occurrence of complications during follow up.

  The occurrence of complications will be reported at two specific time points: at 3 months and 12 months after recruitment.

• Examination of natural history

  Initial visit, 6-8 week visit, 3-month visit, and 12-month visit.

Study Arms (2)

Group 1: Surgical management

Patients aged ≤ 20 years of age recommended for surgery at that visit due to a suspicion of malignancy or pain.

Procedure: Group 1: Surgical management

Group 2: Conservative management (follow-up)

Patients aged ≤ 20 not recommended for surgery due to suspicion of malignancy/complications, for which subjective impression was benign for all visits, and for which the tumour was still present at the next visit.

Diagnostic Test: Group 2: Conservative management (follow-up)

Interventions

Group 2: Conservative management (follow-up) DIAGNOSTIC_TEST

A 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)

Also known as: Ultrasound Assessment

Group 2: Conservative management (follow-up)

Group 1: Surgical management PROCEDURE

A 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.

Also known as: Surgery

Group 1: Surgical management

Eligibility Criteria

• Age: 0 Years - 20 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• All newly diagnosed adnexal masses identified in a girl or adolescent aged 20 or under.

You may not qualify if:

• Participants eligible for this study must not meet any of the following criteria:
• The denial or withdrawal of written informed consent.
• Pregnancy at any timepoint during the study period
• In premenarchal participants: follicle measuring \<10mm

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Central Study Contacts

Dirk Timmerman, Prof.

CONTACT

+3216344202; iota@uzleuven.be

Wouter Froyman, Prof.

CONTACT

3216344202; iota@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: November 18, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): July 21, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 18, 2024

Record last verified: 2024-02

Locations

BE (1)