Ovary CancerMIONCT06331130
Mesenteric Infiltration in Ovarian Cancer
An observational study of Ovary Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
To evaluate if CT features at diagnosis in patients with HGSOC can be used to build an Artificial Intelligence model capable of discerning the pathological involvement of the mesentery, assessing the potential impediments for an optimal debulking surgery and predicting the development of resistance to platinum based… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovary Cancer
- What is being tested?
- Computed Tomography
- How many people
- 510 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 31 Dec 2025
- Phase
- Observational
- 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
- Women only
- Adult, Older adult
Study population: Women with confirmed HGSOC who exhibited mesenteric disease, including mesenteric retraction or diffuse mesenteric carcinomatosis, during diagnostic laparoscopy (or without mesenteric disease for the control cohort)
Who may be able to join
- Women with confirmed HGSOC wiht mesenteric involvment
- Age > 18 years
- FIGO STAGE IIIB-IV
- Primary diagnosis
- Signed informed consent
Who cannot join
- Non-serous high grade epithelial ovarian cancer (serous low grade, mucinous, clear cell carcinoma, endometrioid or non-epithelial ovarian cancer)
- Early stage disease (I and II stage)
- CT scan not available
- Non-primary diagnosis or patient subjected to neoadjuvant chemotherapy
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, 1 recruiting
- Recruiting
Advanced Radiology Center
Roma, 00168
Camilla Panico, MD, +390630158637, camilla.panico@policlinicogemelli.it
About this study
Official title: CT Detected Tumour Infiltration Patterns of the Mesentery in High Grade Ovarian Carcinoma (HGSOC) Patients, Their Role in Treatment Planning and Outcome Prediction and How Machine Learning Can be Applied to Identify Them.
To evaluate if CT features at diagnosis in patients with HGSOC can be used to build an Artificial Intelligence model capable of discerning the pathological involvement of the mesentery, assessing the potential impediments for an optimal debulking surgery and predicting the development of resistance to platinum based chemotherapeutic agents.
- Conditions
- Ovary Cancer
- Being tested
- Computed Tomography
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyDiagnostic test
Computed Tomography done according to Clinical Practice to assess mesenteric involvment
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | Patients affected by High Grade Seruous Ovarian Cancer with mesenteric infiltration confirmed by diagnostic laparoscopy, from January 2021 to December 2023 Receives: Diagnostic Test: Computed Tomography | |
| Prospective cohort | Patients affected by High Grade Seruous Ovarian Cancer with mesenteric infiltration confirmed by diagnostic laparoscopy Receives: Diagnostic Test: Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Artificial Intelligence assisted CT-based evaluation
Preoperative Artificial Intelligence assisted CT-based prediction of patients with suboptimal debulking at surgery due to diffuse mesenteric disease or mesenteric retraction.
Measured: 1 year
Secondary outcomes (3)
Evaluation of the Radiologist Assessment of the CT
Identification of mesenteric infiltration from CT images using Artificial Intelligence at a comparable performance with human/radiologist assessment.
Measured: 1 year
Prediction of Platinum Resistance
AI-assisted CT-based prediction of patients who will develop platinum resistance
Measured: 1 year
Prediction of Progression Free Survival (PFS) and Overall Survival (OS)
Prediction of Progression Free Survival (PFS) and Overall Survival (OS) with Artificial Intelligence
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Mar 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary CancerStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Danube University Krems, Institut du Cancer de Montpellier - Val d'Aurelle, Ente Ospedaliero Cantonale, Ticino, Switzerland
- Responsible party
- Sponsor
- Investigators
- Camilla Panico, Dr, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331130
- Sponsor's protocol ID
- 6363
- Acronym
- MIO
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2024
- Last updated
- 12 Mar 2025
- 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 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Detected Tumour Infiltration Patterns of the Mesentery in High Grade Ovarian Carcinoma (HGSOC) Patients, Their Role in Treatment Planning and Outcome Prediction and How Machine Learning Can be Applied to Identify Them.
- ClinicalTrials.gov ID
- NCT06331130
- Acronym / sponsor ID
- MIO / 6363
- Conditions
- Ovary Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Danube University Krems, Institut du Cancer de Montpellier - Val d'Aurelle, Ente Ospedaliero Cantonale, Ticino, Switzerland
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Mar 2024 (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 evaluate if CT features at diagnosis in patients with HGSOC can be used to build an Artificial Intelligence model capable of discerning the pathological involvement of the mesentery, assessing the potential impediments for an optimal debulking surgery and predicting the development of resistance to platinum based chemotherapeutic agents.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Diagnostic Test: Computed TomographyPatients affected by High Grade Seruous Ovarian Cancer with mesenteric infiltration confirmed by diagnostic laparoscopy, from January 2021 to December 2023 |
| Prospective cohort | – | Diagnostic Test: Computed TomographyPatients affected by High Grade Seruous Ovarian Cancer with mesenteric infiltration confirmed by diagnostic laparoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women with confirmed HGSOC who exhibited mesenteric disease, including mesenteric retraction or diffuse mesenteric carcinomatosis, during diagnostic laparoscopy (or without mesenteric disease for the control cohort)
Key inclusion criteria (5 listed)
- Women with confirmed HGSOC wiht mesenteric involvment
- Age > 18 years
- FIGO STAGE IIIB-IV
- Primary diagnosis
- Signed informed consent
Key exclusion criteria (4 listed)
- Non-serous high grade epithelial ovarian cancer (serous low grade, mucinous, clear cell carcinoma, endometrioid or non-epithelial ovarian cancer)
- Early stage disease (I and II stage)
- CT scan not available
- Non-primary diagnosis or patient subjected to neoadjuvant chemotherapy
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 |
|---|---|---|
| Computed TomographyComputed Tomography done according to Clinical Practice to assess mesenteric involvment | Diagnostic test | Prospective cohort, Retrospective cohort |
Primary outcome
Preoperative Artificial Intelligence assisted CT-based evaluation
Time frame: 1 year
Preoperative Artificial Intelligence assisted CT-based prediction of patients with suboptimal debulking at surgery due to diffuse mesenteric disease or mesenteric retraction.
3 secondary outcomes
Evaluation of the Radiologist Assessment of the CT
Time frame: 1 year
Prediction of Platinum Resistance
Time frame: 1 year
Prediction of Progression Free Survival (PFS) and Overall Survival (OS)
Time frame: 2 years
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 12 Mar 2025.
- 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.
Camilla Panico, Dr principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Ovary 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 12 Mar 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 Camilla Panico, Dr (+390630155701, camilla.panico@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Artificial Intelligence assisted CT-based evaluation (time frame: 1 year). 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 12 Mar 2025.