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| Name | Class |
|---|---|
| Beijing GeneX Health Technology Co., Ltd | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case Group | Participants who were diagnosed as MIBC and plan to receive neoadjuvant therapy before the surgery, above 18 years of age, regardless of gender |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing | Diagnostic Test | Conducting the neoadjuvant therapy of FDA-approved drugs for patients with muscle-invasive bladder carcinoma, culturing the patient-derived tumor-like cell clusters for drug sensitivity testing simultaneously, then assess the accuracy of the diagnostic test by combination and analysis of these results |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) | Disappearance of all target lesions. Any pathological lymph nodes（whether target or non-target）must have reduction in short axis to <10 mm. Length is measured in millimeters, refers to RECIST 1.1. | 3 months |
| Partial Response (PR) | At least a 30ï¼… decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Length is measured in millimeters, refers to RECIST 1.1. | 3 months |
| Progressive Disease (PD) | At least a 20％ increase in the sum of diameters of target lesions, taking as reference the smallest sum on study（this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20％, the sum must also demonstrate an absolute increase of at least 5 mm.（the appearance of one or more new lesions is also considered progression). Length is measured in millimeters, refers to RECIST 1.1. | 3 months |
| Stable Disease (SD) | Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Length is measured in millimeters, refers to RECIST 1.1. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Urology patients with muscle-invasive bladder carcinoma above 18 years of age, at Chinese PLA General Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaoxi Niu, M.D.&Ph.D. | Contact | +8613911353443 | g4niuniu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xu Zhang, M.D.&Ph.D. | Chinese PLA General Hospital | Principal Investigator |
| Hongzhao Li, M.D.&Ph.D. | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32581131 | Background | Yin S, Xi R, Wu A, Wang S, Li Y, Wang C, Tang L, Xia Y, Yang D, Li J, Ye B, Yu Y, Wang J, Zhang H, Ren F, Zhang Y, Shen D, Wang L, Ying X, Li Z, Bu Z, Ji X, Gao X, Jia Y, Jia Z, Li N, Li Z, Ji JF, Xi JJ. Patient-derived tumor-like cell clusters for drug testing in cancer therapy. Sci Transl Med. 2020 Jun 24;12(549):eaaz1723. doi: 10.1126/scitranslmed.aaz1723. | |
| 31030667 |
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| Shaoxi Niu, M.D.&Ph.D. |
| Chinese PLA General Hospital |
| Principal Investigator |
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