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

NCT ID: NCT06839157

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

4489 participants

Study Classification

OBSERVATIONAL

Study Start Date

2027-03-31

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1- SUNNY RCT Trial

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

No interventions assigned to this group

Cohort 2- Pragmatic Trial

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

UNKNOWN

Sponsor Role collaborator

Sun Yat-sen University Cancer Centre

UNKNOWN

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

Shanghai Gynecologic Oncology Group

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SUNNY-AI

Identifier Type: -

Identifier Source: org_study_id

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