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

NCT06787170 | Completed

• 2 other identifiers: KHLL2023-KY20882460340
• Study Type: observational
• Target: 1,129
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

High-grade Serous Ovarian Cancer (HGSOC)

Outcome Measures

Primary Outcomes (1)

• platinum resistance

  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

Interventions

MRI habitat imaging DIAGNOSTIC_TEST

Habitat imaging, a data-driven image processing technique that divides the entire lesion into multiple sub-regions without assuming anything prior, has capacity to noninvasively evaluate the intratumoral heterogeneity.

Also known as: radiopathomics

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HGSOC patients confirmed by surgery and pathology

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First People's Hospital of Yunnan: lead

Study Sites (1)

the First People's Hospital of Yunnan Province

Kunming, Yunnan, 400016, China

Location

Study Officials

• Qiu Bi

  The First People's Hospital of Yunnan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 22, 2025
• Study Start: November 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: May 31, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)