Clinical trial NCT05767528: Clinical Study of Neoadjuvant Therapy Outcome Prediction of Muscle-invasive Bladder Cancer Based on PTC Drug Sensitivity Detection
Official title: Clinical Study of Neoadjuvant Therapy Outcome Prediction of Muscle-invasive Bladder Cancer Based on PTC Drug Sensitivity Detection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Muscle-Invasive Bladder Carcinoma
Keywords: Muscle-Invasive Bladder Carcinoma (MIBC)
Patient-derived tumor-like cell clusters (PTC)
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Beijing GeneX Health Technology Co., Ltd
First posted: 2023-03-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Urology patients with muscle-invasive bladder carcinoma above 18 years of age, at Chinese PLA General Hospital

Brief summary: In this study, investigators plan to conduct the 3D in vitro culture PTC drug sensitivity testing of fresh tumor specimen which obtained by endoscopic biopsy or other methods. Through assessing the consistency between the testing results and the patients' neoadjuvant treatment outcomes, they would evaluate the accuracy of PTC drug sensitivity testing and its application value in the individualized precision medicine for muscle-invasive bladder carcinoma.

Detailed description: This is a prospective observational study. In this study, researchers propose to enroll 40 participants above 18 years of age with muscle-invasive bladder carcinoma, who are going to receive the neoadjuvant therapy before surgery. Collecting fresh tumor samples for PTC drug sensitivity testing, conducting neoadjuvant therapy for the subjects simultaneously. By combining PTC prediction results with the patients' clinical treatment process and medication feedback, researchers could estimate the accuracy of PTC drug sensitivity testing. Completion of this research would provide real-world figures to support for the clinical application for PTC drug sensitivity testing, and a method is going to be established to guide the clinical treatment regimen for patients with muscle-invasive bladder carcinoma.

Eligibility criteria: Inclusion Criteria:

* 1 The lesion of biopsy was diagnosed as muscle-invasive bladder cancer
* 2 Age ≥ 18 years old, regardless of gender
* 3 Treatment plan of bladder removal surgery
* 4 Neoadjuvant therapy before surgery
* 5 Adequate fresh tumor tissue can be obtained by endoscopic biopsy for PTC drug sensitivity testing
* 6 ECOG 0-1, expected survival is more than 3 months
* 7 Normal or stable hepatic, renal, and hematopoietic function
* 8 Normal or stable blood pressure
* 9 The subjects are willing to participate, sign an informed consent form, and have good compliance

Exclusion Criteria:

* 1 Patients with incomplete clinical data
* 2 Central nervous system metastasis
* 3 The presence of other malignant diseases was discovered during treatment, which is going to interfere the study
* 4 Researchers believe that the patient is not suitable for participation after comprehensive evaluation
* 5 Refuse the treatment or follow-up plans

Primary outcomes:
measure: Complete Response (CR)
timeFrame: 3 months
measure: Partial Response (PR)
timeFrame: 3 months
measure: Progressive Disease (PD)
timeFrame: 3 months
measure: Stable Disease (SD)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Xu Zhang, M.D.&Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA General Hospital
name: Hongzhao Li, M.D.&Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA General Hospital
name: Shaoxi Niu, M.D.&Ph.D.
role: PRINCIPAL_INVESTIGATOR
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