Medical EducationUltra-teachingNCT07028229
Ultrasound Training Program for Gynecologic Cancer Staging in Residents
A study testing Training Group in people with Medical Education and Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This is a prospective, interventional study aiming to develop and validate an ultrasound training program for gynecology and obstetrics residents, focused on the staging of gynecologic cancers, including ovarian, endometrial, and cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Education, Ovarian Cancer, Endometrial Cancer
- What is being tested?
- Training Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jun 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least six gynecology residents who will regularly attend the ultrasound center daily, with overlapping shifts.
- All patients with a diagnosis or suspected diagnosis of gynecological cancer, including ovarian, endometrial, and cervical cancers, will be included in the study and scanned by both residents and experts.
- Signing of the informed consent by the participants.
Who cannot join
- non-gynecology specialists, with attendance schedules at the center other than daily.
- Failure to sign the informed consent by the participants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
About this study
Official title: Development and Validation of an Ultrasound Training Program for Residents in Staging Gynecological Cancers (Ovarian Cancer, Endometrial Cancer and Cervical Cancer)
This is a prospective, interventional study aiming to develop and validate an ultrasound training program for gynecology and obstetrics residents, focused on the staging of gynecologic cancers, including ovarian, endometrial, and cervical cancer. The program consists of theoretical lectures, practical hands-on sessions, and supervised clinical case evaluations over a six-month period. Residents will perform ultrasound examinations independently, which will be compared to those conducted by expert sonographers. The primary objective is to assess the learning curve of each trainee by evaluating diagnostic concordance with expert findings across specific staging parameters.
- Conditions
- Medical Education, Ovarian Cancer, Endometrial Cancer, Cervix Cancer
- Being tested
- Training Group
- Keywords
- Resident Training, Learning Curve, Gynecologic Oncology, Transvaginal Ultrasound
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training GroupBehavioural
Also called Ultrasound Training Program for Gynecologic Cancer Staging
A structured educational and practical training program in gynecologic oncology ultrasound designed for residents. The intervention includes lectures, clinical case discussions, supervised and independent ultrasound examinations, and performance assessments to evaluate learning progression and diagnostic concordance with experts.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Gynecology and obstetrics residents enrolled in a structured ultrasound training program focused on staging of gynecologic cancers. The program includes theoretical lessons, supervised hands-on sessions, and independent ultrasound assessments compared with expert findings. Receives: Behavioral: Training Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Rate Between Residents and Experts in Ultrasound-Based Staging of Gynecologic Cancers
Assessment of the diagnostic concordance between ultrasound staging performed by residents and expert sonographers, measured across defined anatomical and pathological parameters (e.g., lymph node involvement, carcinomatosis, tumor size and spread). Concordance will be quantified as the percentage of agreement per case and per parameter.
Measured: Up to 6 months (from the start to the end of the training program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start16 Jun 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EducationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonia Carla Testa, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028229
- Sponsor's protocol ID
- 7738
- Acronym
- Ultra-teaching
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Ultrasound Training Program for Residents in Staging Gynecological Cancers (Ovarian Cancer, Endometrial Cancer and Cervical Cancer)
- ClinicalTrials.gov ID
- NCT07028229
- Acronym / sponsor ID
- Ultra-teaching / 7738
- Conditions
- Medical Education, Ovarian Cancer, Endometrial Cancer, Cervix Cancer
- Keywords
- Resident Training, Learning Curve, Gynecologic Oncology, Transvaginal Ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 16 Jun 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 19 Jun 2025 (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.
This is a prospective, interventional study aiming to develop and validate an ultrasound training program for gynecology and obstetrics residents, focused on the staging of gynecologic cancers, including ovarian, endometrial, and cervical cancer. The program consists of theoretical lectures, practical hands-on sessions, and supervised clinical case evaluations over a six-month period. Residents will perform ultrasound examinations independently, which will be compared to those conducted by expert sonographers. The primary objective is to assess the learning curve of each trainee by evaluating diagnostic concordance with expert findings across specific staging parameters.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Behavioral: Training GroupGynecology and obstetrics residents enrolled in a structured ultrasound training program focused on staging of gynecologic cancers. The program includes theoretical lessons, supervised hands-on sessions, and independent ultrasound assessments compared with expert findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least six gynecology residents who will regularly attend the ultrasound center daily, with overlapping shifts.
- All patients with a diagnosis or suspected diagnosis of gynecological cancer, including ovarian, endometrial, and cervical cancers, will be included in the study and scanned by both residents and experts.
- Signing of the informed consent by the participants.
Key exclusion criteria (2 listed)
- non-gynecology specialists, with attendance schedules at the center other than daily.
- Failure to sign the informed consent by the participants.
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 |
|---|---|---|
| Training GroupAlso: Ultrasound Training Program for Gynecologic Cancer StagingA structured educational and practical training program in gynecologic oncology ultrasound designed for residents. The intervention includes lectures, clinical case discussions, supervised and independent ultrasound examinations, and performance assessments to evaluate learning progression and diagnostic concordance with experts. | Behavioural | Training Group |
Primary outcome
Agreement Rate Between Residents and Experts in Ultrasound-Based Staging of Gynecologic Cancers
Time frame: Up to 6 months (from the start to the end of the training program)
Assessment of the diagnostic concordance between ultrasound staging performed by residents and expert sonographers, measured across defined anatomical and pathological parameters (e.g., lymph node involvement, carcinomatosis, tumor size and spread). Concordance will be quantified as the percentage of agreement per case and per parameter.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
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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.
Antonia Carla Testa principal investigator
Fondazione Policlinico Universitario Agostino Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training Group in people with Medical Education and Ovarian Cancer, 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 2 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: opening soon, as of the sponsor's last update on 19 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonia Carla Testa (0630156399, antoniacarla.testa@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Rate Between Residents and Experts in Ultrasound-Based Staging of Gynecologic Cancers (time frame: Up to 6 months (from the start to the end of the training program)). 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 19 Jun 2025.