Observation of Clinical Consistency of Organoid-chips Drug Sensitivity in Chemotherapy for PCa With Visceral Metastasis
Recruiting · NCT06536725 · Observational (researchers observe without assigning treatment) · Lead sponsor: Tianjin Medical University Second Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Building Organoid-on-chips models
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Patients with visceral metastasis of prostate cancer diagnosed clinically or pathologically;
- Age ≥ 18 years old;
- ECOG score ≤ 2 points or ECOG score 3-4 points due to tumor progression;
- Normal liver and kidney function, serum transaminase ALT\<66 U/L, AST\<36 U/L, total bilirubin\<22 umol/L, creatinine\<106 umol/L, urea nitrogen\<6.1 mmol/L; Normal bone marrow function: neutrophil count ≥ 1800/mm3 and platelet count ≥ 100000/mm3;
- Can obtain surgical or biopsy samples;
- Patients voluntarily join this study and sign an informed consent form.
Exclusion criteria
- Patients with severe heart, liver, kidney, and peripheral nervous system diseases, as well as autoimmune diseases such as hyperthyroidism and hypothyroidism; Systemic lupus erythematosus, etc;
- Patients who are unable to obtain tissue samples;
- Subjects with active pulmonary tuberculosis (TB);
- Subjects who are preparing for or have previously undergone tissue/organ transplantation;
- Exclusion criteria are not listed, but the researchers believe that patients who are not suitable to participate in this clinical study.
Where it is running
2 locations listed.
- Tianjin Medical Unversity Second Hospital - Tianjin, Tianjin Municipality, China
- Tianjin Medical Unversity Second Hospital - Tianjin, Tianjin Municipality, China