Mesenteric Infiltration in Ovarian Cancer (MIO)

March 19, 2024 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

510

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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)

Description

Inclusion Criteria:

  1. Women with confirmed HGSOC wiht mesenteric involvment
  2. Age > 18 years
  3. FIGO STAGE IIIB-IV
  4. Primary diagnosis
  5. Signed informed consent

Exclusion Criteria:

  1. Non-serous high grade epithelial ovarian cancer (serous low grade, mucinous, clear cell carcinoma, endometrioid or non-epithelial ovarian cancer)
  2. Early stage disease (I and II stage)
  3. CT scan not available
  4. Non-primary diagnosis or patient subjected to neoadjuvant chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective cohort
Patients affected by High Grade Seruous Ovarian Cancer with mesenteric infiltration confirmed by diagnostic laparoscopy, from January 2021 to December 2023
Diagnostic test: Computed Tomography
Computed Tomography done according to Clinical Practice to assess mesenteric involvment
Prospective cohort
Patients affected by High Grade Seruous Ovarian Cancer with mesenteric infiltration confirmed by diagnostic laparoscopy
Diagnostic test: Computed Tomography
Computed Tomography done according to Clinical Practice to assess mesenteric involvment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the Radiologist Assessment of the CT
Time Frame: 1 year
Identification of mesenteric infiltration from CT images using Artificial Intelligence at a comparable performance with human/radiologist assessment.
1 year
Prediction of Platinum Resistance
Time Frame: 1 year
AI-assisted CT-based prediction of patients who will develop platinum resistance
1 year
Prediction of Progression Free Survival (PFS) and Overall Survival (OS)
Time Frame: 2 years
Prediction of Progression Free Survival (PFS) and Overall Survival (OS) with Artificial Intelligence
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

Institut du Cancer de Montpellier - Val d'Aurelle
Danube University Krems
Ente Ospedaliero Cantonale, Ticino, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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