Retrospective Review on PAEDIATRIC and ADOLESCENT ADNEXAL MASSES

Adnexal Mass Clinical Trial

Official title:

Retrospective Review on PAEDIATRIC and ADOLESCENT ADNEXAL MASSES

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05461872
• Other study ID #: CRE 2022.205
• Status: Recruiting
• Start date: August 12, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Chinese University of Hong Kong
• Contact: KAREN NG, PI
• Phone: 852-96144255
• Email: ngkaren[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 1 Day to 21 Years

Eligibility

Inclusion Criteria:

• girls who presented with adnexal mass

• aged 0-21 years old

Exclusion Criteria:

• Girls older than 21 years old

Related Conditions & MeSH terms

• Adnexal Mass

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (7)

Akakpo PK, Derkyi-Kwarteng L, Quayson SE, Gyasi RK, Anim JT. Ovarian Tumors in Children and Adolescents: A 10-Yr Histopathologic Review in Korle-Bu Teaching Hospital, Ghana. Int J Gynecol Pathol. 2016 Jul;35(4):333-6. doi: 10.1097/PGP.0000000000000257. — View 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. pii: S0022-3468(17)30638-3. doi: 10.1016/j.jpedsurg.2017.10.016. [Epub ahead of print] — View Citation

Amor F, Vaccaro H, Alcázar JL, León 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. — View 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. — View Citation

Stankovic ZB, Sedlecky K, Savic D, Lukac BJ, Mažibrada 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. — View Citation

Takayasu H, Masumoto K, Tanaka N, Aiyoshi T, Sasaki T, Ono K, Chiba F, Urita Y, Shinkai T. A clinical review of ovarian tumors in children and adolescents. Pediatr Surg Int. 2020 Jun;36(6):701-709. doi: 10.1007/s00383-020-04660-w. Epub 2020 Apr 28. — View 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. — View Citation

Outcome

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