Retrospective Review on PAEDIATRIC and ADOLESCENT ADNEXAL MASSES

August 12, 2022 updated by: NG Karen, Chinese University of Hong Kong
To review the characteristic, presentation and outcome of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background, current evidence and key references:

In paediatric and adolescent girls, preservation of the ovaries for those suffering from ovarian masses requiring surgery is important to maximize future fertility. However, when one faces an ovarian mass in a girl, on one hand, there is potential fertility compromise in those who had extensive ovarian surgery, on the other hand there is a small but non-negligible potential malignancy risk. There are distinct differences in pathologies and imaging findings in girls compared to adults. There arises the question on the most suitable way to triage children for the suitable management, be it conservative, ovarian preserving or more radical surgery.

There have been different diagnostic tools developed to aid the evaluation of adnexal masses in women with only limited evidence on the usage of these tools when being applied to the paediatric and adolescent age group. Attempts have been made in creating treatment guidelines for children, however no prospective randomized trials exist in this area. Therefore, it is important to identify and develop the most suitable triage algorithm for this group of patients.

Aim of study:

In this study, we aim to review the presentation, participant characteristics, imaging findings and histopathological findings, and validate the applicability of the various diagnostic tools in the paediatric and adolescent population to hopefully develop a management algorithm to improve the ovarian preservation rate without jeopardizing the potential malignancy risk in girls with adnexal masses.

Aim to look at whether adult scoring systems for adnexal mass can be applied to the paediatric and adolescent population to differentiate between benign and malignant adnexal masses.

Hypothesis:

The current diagnostic algorithms available for adults are applicable to the paediatric and adolescent population.

Outcome measure:

Participant characteristics, imaging findings, biochemical markers, operative record and histopathological findings, post-operative complications, post-operative menstrual symptoms, and any subsequent reproductive outcome.

Methods of Data Analysis:

The presentation, characteristics, imaging prior to surgery, surgical approaches, histopathological diagnosis and outcome of participant who presented with adnexal masses will be reviewed. The findings according to the data obtained from the review of medical records will be compared to the pre-existing rules and management algorithm for adults. The scoring systems or algorithms will then be validated with histopathological findings or participant outcome to assess applicability in our study population.

SPSS statistical program (SPSS Inc. version 21; IBM Corp., Armonk, NY, USA) was used to analyse the data collected. Normally distributed data was described using means (SD), whereas non-normally distributed data were described using medians (range).

A probability value of <0.05 was considered statistically significant.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 21 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Expecting number of record will be reviewed: 300.

Participant will be identified from review of clinical records.

Participants aged 21 or below who attended the NTEC cluster from 1990-2021 with available medical records.

Since not all data are available in each case, expecting 300 patient records will be reviewed to have target 139 completed record.

Total number of females from HK census in 2021: 0-19 years old: 521857 9-11% are malignant

Sample size calculation work with a 95% confidence level; Confidence interval (margin of error) of ± 5%; Population portion of 10% Population size: 521857

Sample size=139

Description

Inclusion Criteria:

  • girls who presented with adnexal mass
  • aged 0-21 years old

Exclusion Criteria:

  • Girls older than 21 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
girls with adnexal mass

All girls who presented with adnexal mass from 0-21 years old (inclusive).

Subjects will be identified from review of clinical records.

Girl aged 21 or below who attended the NTEC cluster from 1990-2021 with available medical records.
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To review the characteristic of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Time Frame: Baseline
To review the characteristic of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Baseline
To review the imaging findings of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Time Frame: Baseline
To review the imaging findings of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Baseline
To review the biochemical markers of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Time Frame: Baseline
To review the biochemical markers of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Baseline
To review the operative record of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Time Frame: Baseline
To review the operative record of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Baseline
To review the histopathological findings of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Time Frame: Baseline
To review the histopathological findings of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Baseline
To review the post-operative complications of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Time Frame: Baseline
To review the post-operative complications of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Baseline
To review the post-operative menstrual symptoms of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Time Frame: Baseline
To review the post-operative menstrual symptoms of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Baseline
To review the subsequent reproductive outcome of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Time Frame: Baseline
To review the subsequent reproductive outcome of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: KAREN NG, PI, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

June 23, 2022

First Submitted That Met QC Criteria

July 14, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

August 15, 2022

Last Update Submitted That Met QC Criteria

August 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRE 2022.205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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