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Search / Trial NCT07057167

Prediction of Ovarian Cancer Histotypes and Surgical Outcome

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jun 27, 2025

Trial Information

Current as of August 27, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how to better predict the type of ovarian cancer a patient has and how well surgery might work for them. In advanced ovarian cancer, surgery to remove as much tumor as possible is the usual first step, followed by chemotherapy. But sometimes, surgery can’t remove enough of the cancer, especially if the tumor is large or the patient is not strong enough. In these cases, doctors may give chemotherapy first to shrink the tumor before doing surgery. The trial aims to improve how doctors decide which patients should have surgery right away and which should start with chemotherapy by using new tools, including artificial intelligence (AI), to analyze videos from diagnostic procedures and better understand the tumor’s biology during surgery.

Women who are 18 or older, diagnosed with advanced ovarian cancer, and considered fit for initial surgery may be eligible to participate. These patients will undergo a diagnostic laparoscopy, a minimally invasive procedure where doctors look inside the abdomen to assess the tumors before deciding on surgery. The study will use AI technology to help doctors make more accurate, objective decisions during surgery, potentially leading to more personalized and effective treatment plans. This research is important because ovarian cancer varies a lot between patients, and better tools could help improve outcomes by tailoring treatment to each person’s specific cancer type.

Gender

FEMALE

Eligibility criteria

  • Inclusion criteria:
  • Patients over 18 years of age
  • Patients fit for upfront cytoreductive surgery.
  • Patients undergoing diagnostic laparoscopy as part of the upfront decision-making algorithm.
  • Patients with a primary diagnosis of advanced ovarian carcinoma, FIGO stage IIIB - IVB
  • Signature of the informed consent / consent for the processing of personal data and associated data for research purposes in patients treated at the Fondazione Policlinico Universitario A. Gemelli IRCCS (form 743 or form pro.1145.001) / substitute declaration for the consent form for deceased patients.
  • Exclusion criteria:
  • Lack of information on surgical outcome and clinical-pathological characteristics.
  • Ovarian carcinoma patients without evidence of macroscopic peritoneal carcinomatosis (FIGO stage I-IIIA).
  • Secondary cytoreductive surgery.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Patients applied

0 patients applied

Trial Officials

Anna Fagotti

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported