Mesenteric Infiltration in Ovarian Cancer
MIO
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.
1 other identifier
observational
510
1 country
1
Brief 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 chemotherapeutic agents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2024
CompletedFirst Submitted
Initial submission to the registry
March 19, 2024
CompletedFirst Posted
Study publicly available on registry
March 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMarch 12, 2025
March 1, 2025
1.3 years
March 19, 2024
March 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (3)
Evaluation of the Radiologist Assessment of the CT
1 year
Prediction of Platinum Resistance
1 year
Prediction of Progression Free Survival (PFS) and Overall Survival (OS)
2 years
Study Arms (2)
Retrospective cohort
Patients affected by High Grade Seruous Ovarian Cancer with mesenteric infiltration confirmed by diagnostic laparoscopy, from January 2021 to December 2023
Prospective cohort
Patients affected by High Grade Seruous Ovarian Cancer with mesenteric infiltration confirmed by diagnostic laparoscopy
Interventions
Computed Tomography done according to Clinical Practice to assess mesenteric involvment
Eligibility Criteria
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)
You may qualify if:
- Women with confirmed HGSOC wiht mesenteric involvment
- Age \> 18 years
- FIGO STAGE IIIB-IV
- Primary diagnosis
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Advanced Radiology Center
Roma, 00168, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Camilla Panico, Dr
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2024
First Posted
March 26, 2024
Study Start
March 1, 2024
Primary Completion
June 30, 2025
Study Completion
December 31, 2025
Last Updated
March 12, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share