Prediction of Platinum Resistance and Prognosis of High-grade Serous Ovarian Cancer (PPRPHGSOC)

January 21, 2025 updated by: Qiu Bi, The First People's Hospital of Yunnan

Prediction of Platinum Resistance and Prognosis in Patients with High-grade Serous Ovarian Cancer Based on MRI Habitat Imaging and Radiopathomics

High-grade serous ovarian carcinoma (HGSOC) is the most common subtype of ovarian carcinoma. Platinum-based drugs are the first-line chemotherapeutic agents for HGSOC, but platinum resistance and prognosis are difficult to predict. Domestic and foreign studies have found that multi-functional MRI could reflect the macroscopic heterogeneity of tumors from different perspectives; habitat imaging contributed to reflecting the spatial heterogeneity of tumors; the attention mechanism could integrate features of different scales; and multi-omics were capable to improve predictive performance. Previously, our team has demonstrated the importance of MRI and its functional imaging in the diagnosis and histological evaluation of gynecological tumors. And conventional MRI habitat imaging, multi-instance learning based on whole slide image (WSI), and multi-omics model could effectively predict platinum resistance in HGSOC patients. Therefore, this study aims to perform habitat imaging on multi-functional MRI such as multi b-value DWI and DCE-MRI and to train WSI-based multi-instance learning to construct pathological signature. Then, combined with clinical indicators, radiomics based on MRI habitat, and pathomics, a multi-omics fusion model trained by attention mechanism was constructed. Finally, to explore the value of MRI habitat, WSI, and multi-omics in predicting platinum resistance and prognosis in HGSOC patients. This study combines macroscopic functional imaging and microscopic pathological information to construct a multi-omics complementary model, which can predict platinum resistance and prognosis of HGSOC patients more comprehensively and accurately, and further guide the formulation of clinical treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1129

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China, 400016
        • The First People's Hospital of Yunnan Province

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

HGSOC patients confirmed by surgery and pathology

Description

Inclusion Criteria:

  • Patients diagnosed as HGSOC based on surgery and pathology.
  • The standard treatment including surgical cytoreduction followed by at least three cycles of regular platinum-based chemotherapy after surgery.
  • Follow-up records available for more than six months after postoperative chemotherapy.
  • For MRI analysis, pelvic MRI examination including axial T2-weighted imaging (T2WI), contrast-enhanced T1-weighted imaging (CE-T1WI), and diffusion-weighted imaging (DWI) was performed within two weeks prior to treatment, and patients had no any treatments other than neoadjuvant chemotherapy (NACT) performed between MRI and surgery.

Exclusion Criteria:

  • Patients with a history of platinum-based chemotherapy for other malignancies.
  • Absence of essential clinical data.
  • For MRI analysis, patients with poor MRI imaging quality and registration, or a tumor maximum diameter < 1 cm on MRI needed to be excluded.
  • For pathology analysis, patients without H&E-stained WSIs or with poor WSI imaging quality should be excluded.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
platinum resistance
Time Frame: within 6 months
Platinum resistance is determined based on whether there is disease progression during or within 6 months after termination of platinum-based chemotherapy.
within 6 months

Collaborators and Investigators

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

Sponsor

The First People's Hospital of Yunnan

Investigators

  • Principal Investigator: Qiu Bi, The First People's Hospital of Yunnan

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)

November 1, 2022

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHLL2023-KY208
  • 82460340 (Other Grant/Funding Number: National Natural Science Foundations of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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