Artificial Intelligence - Assisted Model for Optimal Timing of Surgery in Advanced Ovarian Cancer

February 23, 2026 updated by: Shanghai Gynecologic Oncology Group

An Artificial Intelligence - Assisted Model for Predicting Optimal Timing of Surgery in Advanced Ovarian Cancer: the Combined Study of the SUNNY Trial and the Real World Data

This study integrates data from the randomized controlled SUNNY trial (RCT) and real-world (RWD) data, and employs multimodal data fitting to construct a medical artificial intelligence model to identify the clinical characteristics of patient subgroups suitable for primary debulking surgery (PDS) or interval debulking surgery (IDS), and the cutoff values for selecting different timings of surgery for advanced ovarian cancer.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1025

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

No

Sampling Method

Non-Probability Sample

Study Population

Patients who were included in the SUNNY study or who were newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer during the SUNNY study period (2015-2023)

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients who were included in the SUNNY study or who were newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer during the SUNNY study period (2015-2023)
  • Underwent primary debulking surgery or interval debulking surgery
  • Data avaliable on first-line treatment and follow-up

Exclusion Criteria:

  • Non-epithelial ovarian cancer or borderline tumors.
  • Low-grade tumors.
  • Mucinous ovarian cancer.
  • Missing data on first-line treatment and follow-up

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
Cohort 1- SUNNY RCT Trial
489 patients who were enrolled and randomized in the SUNNY RCT trials.
Cohort 2- Pragmatic Trial
536 patients who were newly diagnosed as stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer between 2021 and 2025

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The accuracy of predicting the 3-year overall survival (OS) difference between primary debulking surgery (PDS) and interval debulking surgery (IDS).
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Shanghai Gynecologic Oncology Group

Collaborators

Zhejiang Cancer Hospital
Fudan University
Shanghai Zhongshan Hospital
Sun Yat-sen University Cancer Centre

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)

August 22, 2016

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

February 21, 2025

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • SUNNY-AI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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