Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-25 @ 4:20 PM
Study NCT ID:
NCT06017557
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2023-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predicting Outcome of Cytoreduction in Advanced Ovarian Cancer
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
Official Title:
Predicting Outcome of Cytoreduction in Advanced Ovarian Cancer, Using a Machine Learning Algorithm and Patterns of Disease Distribution at Laparoscopy (PREDAtOOR)
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREDAtOOR
Brief Summary:
PREDAtOOR is a pilot study and this study aims at improving the selection of the best treatment strategy for patients with advanced ovarian cancer by using Camera Vision (CV) to predict outcomes of cyto reduction at the time of Diagnostic laparoscopy.
Detailed Description:
For the treatment of advanced ovarian cancer, the decision to undergo primary surgery is complex and decided by the surgeon while multiple considering multiple elements. Sometimes, chemotherapy is needed before surgery to shrink some of the tumours. To choose the best patients for primary surgery, several prediction tools have been developed. CT and MRI have most commonly been used to identify sites and amounts of tumors in the abdomen and can help determine if these tumours can be safely removed by surgery. However, these imaging methods are only a prediction, and sometimes a diagnostic laparoscopy (putting a camera in the abdomen to look at all sites of disease) is performed to help this decision process.
With the introduction of artificial intelligence and machine learning, there is a possibility to create more precise prediction models using images from these diagnostic laparoscopy videos. In particular, the investigators would like to use images from the diagnostic laparoscopy to create machine-learning models to help predict if the tumours can be successfully taken out at primary surgery, or if chemotherapy before surgery would be needed.
The investigators will enroll patients at a one-time point (being the time of surgery) and follow them forward in time and There will be no additional visits other than the surgery.
During surgery time the surgical team takes images however, what makes this different is that these images will be used to help create an algorithm to predict surgical outcomes. These images will be stored in a secure database with an anonymous number not linking these pictures to any of the participants.
With the introduction of artificial intelligence and machine learning, there is a possibility to create more precise prediction models using images from these diagnostic laparoscopy videos. In particular, the investigators would like to use images from the diagnostic laparoscopy to create machine-learning models to help predict if the tumours can be successfully taken out at primary surgery, or if chemotherapy before surgery would be needed.
The investigators will enroll patients at a one-time point (being the time of surgery) and follow them forward in time and There will be no additional visits other than the surgery.
During surgery time the surgical team takes images however, what makes this different is that these images will be used to help create an algorithm to predict surgical outcomes. These images will be stored in a secure database with an anonymous number not linking these pictures to any of the participants.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: