Clinical trial NCT06909643: Development and Prospective Validation of a Multimodal Fusion Artificial Intelligence Model for Predicting the Efficacy of Neoadjuvant Treatment of Bladder Cancer
Official title: Development and Prospective Validation of a Multimodal Fusion Artificial Intelligence Model for Predicting the Efficacy of Neoadjuvant Treatment of Bladder Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Neoadjuvant Therapy
Keywords: Artificial Intelligence
Multimodal Fusion
Therapy Prediction
Magnetic Resonance Imaging
Digital Pathology
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 550
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pathologically confirmed bladder cancer who undergo neoadjuvant therapy and radical cystectomy are planned to be enrolled in this diagnostic test to assess the model's clinical application capability.

Brief summary: This study is a multi-center observational study without interventions, including the construction of an AI diagnostic model and retrospective testing of a multi-center cohort. The study participants are bladder cancer patients who have undergone imaging examinations, been pathologically diagnosed, and received neoadjuvant treatment, with complete clinical and pathological data. The study plans to enroll 130 patients from our center, collecting corresponding imaging images, and gathering clinical and genomic data to build and internally validate a multimodal AI model. The model's generalization and robustness will be tested to explore the association between multimodal data and the efficacy of neoadjuvant treatment for bladder cancer. The aim is to assist clinicians in predicting and evaluating the efficacy of neoadjuvant treatment for bladder cancer, with the goal of improving patient diagnosis, treatment outcomes, and prognosis.

Detailed description: Bladder cancer is one of the most common malignancies of the genitourinary system worldwide. For muscle - invasive bladder cancer amenable to radical resection, the standard treatment is neoadjuvant therapy combined with radical cystectomy, with neoadjuvant therapy playing a crucial role. Currently, numerous studies have shown that cisplatin - based neoadjuvant chemotherapy can downstage tumors, reduce the risk of mortality in bladder cancer patients, improve survival rates, and enhance prognosis. Other treatment approaches such as neoadjuvant immunotherapy, targeted therapy, and combination therapies are also under investigation. However, responses to neoadjuvant therapy vary among bladder cancer patients, with some not achieving the desired therapeutic goals. Therefore, accurately predicting participants' response to treatment can provide an important reference for personalized and precise treatment of bladder cancer.

In recent years, as advancements in computational power and data storage capacity, artificial intelligence (AI) has been widely applied in the field of digital diagnostics. AI technologies can extract and integrate a large number of features from multimodal data such as pathology, imaging, and clinical records, enabling precise disease diagnosis, prognosis assessment, and treatment prediction. In the field of tumor treatment prediction, multimodal AI technologies have achieved numerous breakthroughs, developing efficacy prediction models for tumors such as rectal and breast cancer based on imaging and pathological data, and validating the models' generalization capabilities through external validation.

Therefore, the investigators plan to construct and validate a "Bladder Cancer Neoadjuvant Treatment Efficacy Prediction Model" based on multimodal data such as MRI images, digital pathology images, and clinical records of bladder cancer patients, and develop an AI - assisted prediction software for neoadjuvant treatment efficacy in bladder cancer. The investigators hope that this AI diagnostic model can serve as an auxiliary tool to assist clinicians in stratifying neoadjuvant treatment efficacy in bladder cancer patients, thereby formulating precise treatment plans, reducing the consumption of human and material resources, and seizing the optimal treatment opportunities.

Eligibility criteria: Inclusion Criteria:

* Bladder occupying lesions, with histopathological confirmation of bladder cancer after resection.
* Planned neoadjuvant therapy and radical cystectomy.

Exclusion Criteria:

* Patients who have not undergone standard bladder imaging examinations or have missing imaging or pathological data.
* Patients who have received local treatments (such as interventional embolization) or systemic treatments (such as radiotherapy, chemotherapy, immunotherapy, or targeted therapy).
* Poor quality of imaging or pathological images.

Primary outcomes:
measure: sensitivity
timeFrame: For each enrolled patient, the diagnosis results of AI model will be obtained in several days after neoadjuvant therapy, and the sensitivity of the AI model will be evaluated through study completion, an average of 3 year.
Secondary outcomes:
measure: specificity
timeFrame: For each enrolled patient, the diagnosis results of AI model will be obtained in several days after neoadjuvant therapy, and the specificity of the AI model will be evaluated through study completion, an average of 3 year.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: