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

Shanghai Gynecologic Oncology Group

Status: Begins enrollment in a year or more

Conditions: Artificial Intelligence (AI); Ovarian, Fallopian, and Primary Peritoneal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06839157

SUNNY-AI

Details and patient eligibility

About

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.

Enrollment: 4,489 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4,489 participants in 2 patient groups

Cohort 1- SUNNY RCT Trial

Description:

489 patients who were enrolled and randomized in the SUNNY RCT trials.

Cohort 2- Pragmatic Trial

Description:

4000 patients who were newly diagnosed as stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer between 2015 and 2024