Clinical trial NCT05461872: Retrospective Review on PAEDIATRIC and ADOLESCENT ADNEXAL MASSES
Official title: Retrospective Review on PAEDIATRIC and ADOLESCENT ADNEXAL MASSES
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adnexal Mass
Keywords: Paediatric
ovarian cyst
ovarian tumor
torsion
adolescent adnexal mass
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief summary: To review the characteristic, presentation and outcome of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Girls older than 21 years old

Primary outcomes:
measure: To review the characteristic of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
timeFrame: Baseline
measure: To review the imaging findings of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
timeFrame: Baseline
measure: To review the biochemical markers of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
timeFrame: Baseline
measure: To review the operative record of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
timeFrame: Baseline
measure: To review the histopathological findings of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
timeFrame: Baseline
measure: To review the post-operative complications of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
timeFrame: Baseline
measure: To review the post-operative menstrual symptoms of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
timeFrame: Baseline
measure: To review the subsequent reproductive outcome of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: KAREN NG, PI
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Amor F, Vaccaro H, Alcazar JL, Leon M, Craig JM, Martinez J. Gynecologic imaging reporting and data system: a new proposal for classifying adnexal masses on the basis of sonographic findings. J Ultrasound Med. 2009 Mar;28(3):285-91. doi: 10.7863/jum.2009.28.3.285.
citation: Andreotti RF, Timmerman D, Strachowski LM, Froyman W, Benacerraf BR, Bennett GL, Bourne T, Brown DL, Coleman BG, Frates MC, Goldstein SR, Hamper UM, Horrow MM, Hernanz-Schulman M, Reinhold C, Rose SL, Whitcomb BP, Wolfman WL, Glanc P. O-RADS US Risk Stratification and Management System: A Consensus Guideline from the ACR Ovarian-Adnexal Reporting and Data System Committee. Radiology. 2020 Jan;294(1):168-185. doi: 10.1148/radiol.2019191150. Epub 2019 Nov 5.
citation: Stankovic ZB, Sedlecky K, Savic D, Lukac BJ, Mazibrada I, Perovic S. Ovarian Preservation from Tumors and Torsions in Girls: Prospective Diagnostic Study. J Pediatr Adolesc Gynecol. 2017 Jun;30(3):405-412. doi: 10.1016/j.jpag.2017.01.008. Epub 2017 Jan 27.
citation: Timmerman D, Testa AC, Bourne T, Ameye L, Jurkovic D, Van Holsbeke C, Paladini D, Van Calster B, Vergote I, Van Huffel S, Valentin L. Simple ultrasound-based rules for the diagnosis of ovarian cancer. Ultrasound Obstet Gynecol. 2008 Jun;31(6):681-90. doi: 10.1002/uog.5365.
citation: Aldrink JH, Gonzalez DO, Sales SP, Deans KJ, Besner GE, Hewitt GD. Using quality improvement methodology to improve ovarian salvage for benign ovarian masses. J Pediatr Surg. 2017 Oct 10:S0022-3468(17)30638-3. doi: 10.1016/j.jpedsurg.2017.10.016. Online ahead of print.