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Clinical Trials/NCT03952793
NCT03952793
Terminated
Not Applicable

Development of the Organoids Technique From Metastases From Patients With Advanced Form of Prostate Cancer: Use in Basic Research

Centre Antoine Lacassagne1 site in 1 country1 target enrollmentDecember 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostatic Neoplasm
Sponsor
Centre Antoine Lacassagne
Enrollment
1
Locations
1
Primary Endpoint
Success rate of establishment of the organoid culture
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

The aim of the study is the development of the organoid culture technique from metastases from patients with advanced form of prostate cancer. Once the technique is set up, the organoid will serve to test several antitumor molecules.

Registry
clinicaltrials.gov
Start Date
December 4, 2019
End Date
October 25, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient with metastatic prostate cancer
  • Patient having a biopsy programmed as part of his care.
  • Patient having a biopsy programmed as part of hiscare.
  • Patient with sufficient tumor volume after imaging data review by the radiologist to guarantee a sufficient quantity of material for the diagnosis of biopsy and additional material for the study.
  • INR \<1.5; Platelets \> 50000 / μL

Exclusion Criteria

  • Patient under age of 18 years.
  • Patient under Plavix or Effient or Ticlid without possibility of suspension for 5 days, low molecular weight heparin without possibility of suspension of the dose before the intervention, or Fondaparinux without possibility of suspension, or ReoPro without possibility of suspension for 24h and aPTT \<50s and ACT \<150s, or Integrilin or Aggrastat or Argatroban without possibility of suspension 4 H before the intervention, or Angiomax without possibility of suspending 2H to 3H if CrCL\> 50 mL / min or 3H to 5h if CrCL \<50 mL / min before the intervention or and Pradaxa without possibility of suspension 2 to 3 days if CrCL\> 50 mL / min or 3 to 5 days if CrCL \<50 mL / min before the procedure
  • Patient under desmopressin acetate (DDAVP)
  • Patient with HIV or Hepatitis C positive or Hepatitis B infection, defined by either a detection of the HBs antigen or the presence of anti HBc antibodies without HBs antibody detectable.

Outcomes

Primary Outcomes

Success rate of establishment of the organoid culture

Time Frame: 15 days

The success rate is defined by the rate of successful cell culture. A Cell culture is successful when organoids grow from dividing cells

Secondary Outcomes

  • Cell proliferation Molecular and cellular on mechanisms of drugs responses(20 days)
  • Drugs testing on organoid for cell viability(20 days)
  • Cell Apoptosis Molecular and cellular mechanisms of drugs responses(20 days)

Study Sites (1)

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