Ovarian CystsOvaMa-PEDsNCT05800613
Management of Ovarian Masses in Pediatric Patients: an Italian Survey
An observational study of Ovarian Cysts and Pediatric ALL, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Objectives: The International Ovarian Tumor Analysis (IOTA) provides a specific terminology for adult ovarian masses, while, currently, there is no systematic classification for preoperative assessment of adnexal lesions in childhood and adolescence. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ovarian Cysts, Pediatric ALL, Diagnosis
- What is being tested?
- Survey
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jun 2022to 30 Dec 2022
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Pediatric surgeons who work in public hospitals that have managed or collaborated in the management of pediatric patients affected by ovarian cyst. Signed informed consent for participation in the study and for the use of personal data.
Who may be able to join
- Pediatric surgeons who work in public hospitals that have managed or collaborated in the management of pediatric patients affected by ovarian cyst.
- Signed informed consent for participation in the study and for the use of personal data.
- Exclusion Criteria No answer and/or non-completion of the questionnaire within 1 month after sending our e-mail.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome
Roma, 00168
About this study
Objectives: The International Ovarian Tumor Analysis (IOTA) provides a specific terminology for adult ovarian masses, while, currently, there is no systematic classification for preoperative assessment of adnexal lesions in childhood and adolescence. This study aims to survey Italian pediatric surgeons to evaluate ovarian masses' management (from diagnosis to treatment) in patients aged 1-18.
Methods: A 27-question survey was distributed. It consisted of questions regarding the management and use of ultrasound and IOTA terminology in diagnosing ovarian masses in childhood and adolescence, in emergency regimes and in planned surgeries.
Read the detailed description
PURPOSE AND OBJECTIVES OF THE CLINICAL TRIAL The aim of the present study is to propose a survey among Italian Pediatric Surgeons (inside the Società Italiana di Chirurgia Pediatrica-SICP) to evaluate the current management of ovarian masses in patients aged 1 -18, in terms of preoperative work up and surgical modalities.
EXPERIMENTAL DESIGN
PRIMARY OBJECTIVE:
To evaluate the current management of ovarian masses in patients aged between 1 and 18.
EXPERIMENTAL PLAN:
Observational study, survey.
SETTING:
This is an online survey designed using REDCap forms feature. Data will be collected in a period of 6 months. The informed consent forms for participation, use of personal data and the link for the questionnaire will be sent by e-mail to all Italian Pediatric Surgeons belonging to the SICP. The surgeons who accept to participate, will return both signed consent forms and a copy of their Identity Card.
The survey is divided into seven sections.
- Section 1: demographic data.
- Section 2: data on surgical background of the institution and the pediatric surgeons.
- Section 3: management of pediatric patients in emergency.
- Section 4: management of pediatric patients who had planned surgery.
- Section 5: additional management data.
- Section 6: knowledge of the IOTA group and terminology.
- Section 7: availability to participate in a multi-center retrospective study.
Questions asked for responses using yes/no, multiple-choice, or short freeform written answers. More than one response could be given for many questions, it is specified.
(The detailed description is reported in the attachment 1).
- Conditions
- Ovarian Cysts, Pediatric ALL, Diagnosis
- Being tested
- Survey
- Keywords
- ovarian cysts, Pediatric patients, Ultrasound, Survey
- Medical subject headings
- Ovarian Cysts, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the current management of ovarian masses in patients aged between 1 and 18
Collect data from the survey
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start16 Jun 2022
- Primary completion30 Nov 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CystsStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moro Francesca, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800613
- Sponsor's protocol ID
- 5003
- Acronym
- OvaMa-PEDs
- Status last verified
- Mar 2023
- First submitted
- 24 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Ovarian Masses in Pediatric Patients: an Italian Survey
- ClinicalTrials.gov ID
- NCT05800613
- Acronym / sponsor ID
- OvaMa-PEDs / 5003
- Conditions
- Ovarian Cysts, Pediatric ALL, Diagnosis
- Keywords
- ovarian cysts, Pediatric patients, Ultrasound, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 5 Apr 2023 (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.
Objectives: The International Ovarian Tumor Analysis (IOTA) provides a specific terminology for adult ovarian masses, while, currently, there is no systematic classification for preoperative assessment of adnexal lesions in childhood and adolescence. This study aims to survey Italian pediatric surgeons to evaluate ovarian masses' management (from diagnosis to treatment) in patients aged 1-18.
Methods: A 27-question survey was distributed. It consisted of questions regarding the management and use of ultrasound and IOTA terminology in diagnosing ovarian masses in childhood and adolescence, in emergency regimes and in planned surgeries.
Detailed description
PURPOSE AND OBJECTIVES OF THE CLINICAL TRIAL The aim of the present study is to propose a survey among Italian Pediatric Surgeons (inside the Società Italiana di Chirurgia Pediatrica-SICP) to evaluate the current management of ovarian masses in patients aged 1 -18, in terms of preoperative work up and surgical modalities.
EXPERIMENTAL DESIGN
PRIMARY OBJECTIVE:
To evaluate the current management of ovarian masses in patients aged between 1 and 18.
EXPERIMENTAL PLAN:
Observational study, survey.
SETTING:
This is an online survey designed using REDCap forms feature. Data will be collected in a period of 6 months. The informed consent forms for participation, use of personal data and the link for the questionnaire will be sent by e-mail to all Italian Pediatric Surgeons belonging to the SICP. The surgeons who accept to participate, will return both signed consent forms and a copy of their Identity Card.
The survey is divided into seven sections.
- Section 1: demographic data.
- Section 2: data on surgical background of the institution and the pediatric surgeons.
- Section 3: management of pediatric patients in emergency.
- Section 4: management of pediatric patients who had planned surgery.
- Section 5: additional management data.
- Section 6: knowledge of the IOTA group and terminology.
- Section 7: availability to participate in a multi-center retrospective study.
Questions asked for responses using yes/no, multiple-choice, or short freeform written answers. More than one response could be given for many questions, it is specified.
(The detailed description is reported in the attachment 1).
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric surgeons who work in public hospitals that have managed or collaborated in the management of pediatric patients affected by ovarian cyst. Signed informed consent for participation in the study and for the use of personal data.
Key inclusion criteria (3 listed)
- Pediatric surgeons who work in public hospitals that have managed or collaborated in the management of pediatric patients affected by ovarian cyst.
- Signed informed consent for participation in the study and for the use of personal data.
- Exclusion Criteria No answer and/or non-completion of the questionnaire within 1 month after sending our e-mail.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SurveyQuestionnaire | Other | – |
Primary outcome
To evaluate the current management of ovarian masses in patients aged between 1 and 18
Time frame: 6 months
Collect data from the survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ovarian Cysts and Pediatric ALL, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 3 inclusion and 0 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: finished, as of the sponsor's last update on 5 Apr 2023. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the current management of ovarian masses in patients aged between 1 and 18 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2023.