Clinical trial NCT06787170: Prediction of Platinum Resistance and Prognosis of High-grade Serous Ovarian Cancer
Official title: Prediction of Platinum Resistance and Prognosis in Patients with High-grade Serous Ovarian Cancer Based on MRI Habitat Imaging and Radiopathomics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High-grade Serous Ovarian Cancer (HGSOC)
Lead sponsor: The First People's Hospital of Yunnan
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 1129
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HGSOC patients confirmed by surgery and pathology

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.


Eligibility criteria: 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.

Primary outcomes:
measure: platinum resistance
timeFrame: within 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: the First People's Hospital of Yunnan Province
state: Yunnan
Study officials:
affiliation: The First People's Hospital of Yunnan
name: Qiu Bi
role: PRINCIPAL_INVESTIGATOR
References: