Adnexal MassNCT05461872
Retrospective Review on PAEDIATRIC and ADOLESCENT ADNEXAL MASSES
An observational study of Adnexal Mass, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 1 day to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adnexal Mass
- How many people
- 300 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Aug 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- girls who presented with adnexal mass
- aged 0-21 years old
Who cannot join
- Girls older than 21 years old
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
KAREN NG, 852-96144255, ngkaren@cuhk.edu.hk
KATHERINE LEE, 852-35052583, kayankatherinelee@cuhk.edu.hk
About this study
To review the characteristic, presentation and outcome of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses.
Read the 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.
- Conditions
- Adnexal Mass
- Being tested
- No intervention
- Keywords
- Paediatric, ovarian cyst, ovarian tumor, torsion, adolescent adnexal mass
- Medical subject headings
- Ovarian Cysts, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start12 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Adnexal MassStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NG Karen, Chinese University of Hong Kong
- Investigators
- KAREN NG, PI, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461872
- Sponsor's protocol ID
- CRE 2022.205
- Status last verified
- Aug 2022
- First submitted
- 23 Jun 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32346848Akakpo 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.
PubMed 26630227Amor 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.
PubMed 19244063Andreotti 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.
PubMed 31687921Stankovic 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.
PubMed 28137453Timmerman 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.
PubMed 18504770Aldrink 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.
PubMed 29106919
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review on PAEDIATRIC and ADOLESCENT ADNEXAL MASSES
- ClinicalTrials.gov ID
- NCT05461872
- Acronym / sponsor ID
- CRE 2022.205
- Conditions
- Adnexal Mass
- Keywords
- Paediatric, ovarian cyst, ovarian tumor, torsion, adolescent adnexal mass
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| girls with adnexal mass | – | Other: No interventionAll 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. |
Who may qualify
- Ages
- 1 day to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- girls who presented with adnexal mass
- aged 0-21 years old
Key exclusion criteria (1 listed)
- Girls older than 21 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | girls with adnexal mass |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Background: PubMed 32346848Takayasu 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.
- Background: PubMed 26630227Akakpo 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.
- Background: PubMed 19244063Amor 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.
- Background: PubMed 31687921Andreotti 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.
- Background: PubMed 28137453Stankovic 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.
- Background: PubMed 18504770Timmerman 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.
- Background: PubMed 29106919Aldrink 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KAREN NG, PI principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adnexal Mass, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KAREN NG, PI (852-96144255, ngkaren@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To review the characteristic of girls presented with adnexal masses to hopefully develop a management algorithm for girls with adnexal masses. (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05461872, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.