Retrospective Review on PAEDIATRIC and ADOLESCENT ADNEXAL MASSES

NCT05461872 | Unknown

• 1 other identifier: CRE 2022.205
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Adnexal Mass

Keywords

Paediatric; ovarian cyst; ovarian tumor; torsion; adolescent adnexal mass

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

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

Interventions

No intervention OTHER

No intervention

girls with adnexal mass

Eligibility Criteria

• Age: 1 Day - 21 Years
• Gender Eligibility Details: All girls who presented with adnexal mass from 0-21 years old (inclusive)
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• Girls older than 21 years old

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (7)

• 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.

  PMID: 32346848 BACKGROUND

• 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.

  PMID: 26630227 BACKGROUND

• 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.

  PMID: 19244063 BACKGROUND

• 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.

  PMID: 31687921 BACKGROUND

• 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.

  PMID: 28137453 BACKGROUND

• 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.

  PMID: 18504770 BACKGROUND

• 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.

  PMID: 29106919 BACKGROUND

MeSH Terms

Conditions

Ovarian Cysts; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Urogenital Neoplasms

Study Officials

• KAREN NG, PI

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KAREN NG, PI

CONTACT

852-96144255; ngkaren@cuhk.edu.hk

KATHERINE LEE, Investigator

CONTACT

852-35052583; kayankatherinelee@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 18, 2022
• Study Start: August 12, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 15, 2022

Record last verified: 2022-08

Locations

HK (1)