NCT05800613

Brief Summary

Objectives: The International Ovarian Tumor Analysis (IOTA) provides a specific terminology for adult ovarian masses, while, currently, there is no systematic classification for preoperative assessment of adnexal lesions in childhood and adolescence. This study aims to survey Italian pediatric surgeons to evaluate ovarian masses' management (from diagnosis to treatment) in patients aged 1-18. Methods: A 27-question survey was distributed. It consisted of questions regarding the management and use of ultrasound and IOTA terminology in diagnosing ovarian masses in childhood and adolescence, in emergency regimes and in planned surgeries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
Last Updated

April 5, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

March 24, 2023

Last Update Submit

March 24, 2023

Conditions

Keywords

ovarian cystsPediatric patientsUltrasoundSurvey

Outcome Measures

Primary Outcomes (1)

  • To evaluate the current management of ovarian masses in patients aged between 1 and 18

    Collect data from the survey

    6 months

Interventions

SurveyOTHER

Questionnaire

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pediatric surgeons who work in public hospitals that have managed or collaborated in the management of pediatric patients affected by ovarian cyst. Signed informed consent for participation in the study and for the use of personal data.

You may qualify if:

  • Pediatric surgeons who work in public hospitals that have managed or collaborated in the management of pediatric patients affected by ovarian cyst.
  • Signed informed consent for participation in the study and for the use of personal data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Ovarian CystsPrecursor Cell Lymphoblastic Leukemia-LymphomaDisease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

CystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 24, 2023

First Posted

April 5, 2023

Study Start

June 16, 2022

Primary Completion

November 30, 2022

Study Completion

December 30, 2022

Last Updated

April 5, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations