Observation of Clinical Consistency of Organoid-chips Drug Sensitivity in Chemotherapy for PCa With Visceral Metastasis

NCT ID: NCT06536725

Last Updated: 2024-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer Organoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PCa Patients With Visceral Metastasis

Prostate cancer patients with visceral metastasis.

Building Organoid-on-chips models

Intervention Type OTHER

This project obtains surgical or biopsy samples from prostate cancer patients with visceral metastasis for the construction of organoids.

Interventions

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Building Organoid-on-chips models

This project obtains surgical or biopsy samples from prostate cancer patients with visceral metastasis for the construction of organoids.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients with visceral metastasis of prostate cancer diagnosed clinically or pathologically;
2. Age ≥ 18 years old;
3. ECOG score ≤ 2 points or ECOG score 3-4 points due to tumor progression;
4. 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;
5. Can obtain surgical or biopsy samples;
6. Patients voluntarily join this study and sign an informed consent form.

Exclusion Criteria

1. 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;
2. Patients who are unable to obtain tissue samples;
3. Subjects with active pulmonary tuberculosis (TB);
4. Subjects who are preparing for or have previously undergone tissue/organ transplantation;
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Second Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haitao Wang, Ph.D

Role: CONTACT

+86-022-88326385

Jinhuan Wang, Ph.D

Role: CONTACT

+86-022-88326610

Facility Contacts

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Haitao Wang

Role: primary

+86-02288326610

Lili Wang

Role: backup

+86-13516108466

Haitao Wang, Ph.D

Role: primary

+86-022-88326385

Lili Wang, MM

Role: backup

+86-022-88326610

Other Identifiers

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Organoid-on-chips-PCa

Identifier Type: -

Identifier Source: org_study_id

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