Building Organoid-on-chips models
OtherThis project obtains surgical or biopsy samples from prostate cancer patients with visceral metastasis for the construction of organoids.
NCT Number: NCT06536725
This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans.
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Request Info18 year and older
Male
Observational
Tianjin Medical Unversity Second Hospital, Tianjin, Tianjin Municipality, China
This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans;The final medication regimen for patients is determined by doctors based on their experience and in vitro drug sensitivity results. The actual clinical efficacy of medication is tracked for patients, and the organoid chip drug sensitivity detection model is analyzed as a predictor of the sensitivity, specificity, and accuracy of anti-tumor chemotherapy drugs, providing data reference for clinical applications.At the same time, analyze the accuracy of drug sensitivity testing results and clinical empirical medication.If patients are treated with a chemotherapy combined with immunotherapy regimen, the in vitro sensitivity of immune drugs will be determined using organoid-immune co-culture technology, and exploratory research on the predictive performance of immune models will be conducted in conjunction with clinical medication.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This project obtains surgical or biopsy samples from prostate cancer patients with visceral metastasis for the construction of organoids.
Time frame: 18 months
Selecting ORR as the primary endpoint from clinical efficacy evaluation indicators.Evaluation of the best objective response rate (ORR) for each treatment according to RECIST 1.1. The best ORR is the best response reached during treatment according to RECIST 1.1 criteria.
Time frame: 18 months
Sensitivity, specificity, and accuracy of drug sensitivity testing results based on successfully constructed organoids for predicting the main clinical efficacy evaluation indicators.
Time frame: 18 months
The main tumor marker monitored is TPSA.The levels of PSA will be monitored every 3 (or 4) weeks for comparison to baseline levels until the time of PSA progression, as defined by PCWG3 criteria.The levels of other tumor markers will be monitored every 3 (or 4) weeks for comparison to baseline levels until the time of tumor markers progression.
Time frame: 18 months
Progression-free survival (PFS) is defined as the time from the date of the first administration of patients medication plan based on organoids drug sensitivity test to the date of the first documentation of disease progression or death due to any cause, whichever comes first, censored at the last date at which the participant was determined to be progression-free.
Contact information is provided by the study sponsor or research team.
Haitao Wang, Ph.D
CONTACT
Jinhuan Wang, Ph.D
CONTACT
Tianjin Medical University Second Hospital
Other
Observation of Clinical Consistency of Organoid-on-chips Drug Sensitivity Detection in Chemotherapy for Prostate Cancer Patients With Visceral Metastasis
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