NCT06839157

Brief Summary

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,025

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Aug 2016

Longer than P75 for all trials

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Aug 2016Jun 2027

Study Start

First participant enrolled

August 22, 2016

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 25, 2026

Status Verified

February 1, 2025

Enrollment Period

10.8 years

First QC Date

February 18, 2025

Last Update Submit

February 23, 2026

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • The accuracy of predicting the 3-year overall survival (OS) difference between primary debulking surgery (PDS) and interval debulking surgery (IDS).

    3 years

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

The treatment-naive paraffin specimens will be retrospectively collected.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2025

First Posted

February 21, 2025

Study Start

August 22, 2016

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

February 25, 2026

Record last verified: 2025-02