- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07820566
Development of a Preclinical 3D Vascularized and Perfused Tumoroid Model in Oncology and Urology Developed From Patient Tumors (Kidney, Bladder, and Prostate Cancers) (3DBlood)
This is a study :
- Single-center
- Prospective
- Translational
- Based on data and blood samples. In this context, the aim is to collect approximately 10 ml of blood from each patient included in the 3D tumoroid development project.
The main objective is to establish and validate a panel of vascularized and perfused 3D tumoroids for personalized medicine based on patient tumors for urological cancers, incorporating autologous immune cells.
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Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hervé LANG, PUPH
- Phone Number: 33369550974
- Email: Herve.Lang@chru-strasbourg.fr
Study Locations
-
-
-
Strasbourg, France, 67091
- Recruiting
- Service de Chirurgie Urologique _ Hôpitaux Universitaires de Strasbourg
-
Contact:
- Hervé LANG, PUPH
- Phone Number: 33 3 69 55 09 74
- Email: herve.lang@chru-strasbourg.fr
-
Principal Investigator:
- Hervé LANG, PUPH
-
Sub-Investigator:
- Nicolas MEYER, PUPH
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
- Male or female subject (≥18 years old);
- Diagnosed with kidney cancer, prostate cancer, or bladder cancer;
- whose tumor tissue and associated data are reused as part of the SphéroUro protocol (study outside the Jardé law, retrospective study on tumor tissue and associated data, from the biobank registered with the Ministry of Education and Research under reference No. DC 2016-2677)
Description
Inclusion Criteria:
Inclusion criteria:
Criteria common to all patients:
- Male or female subject (≥18 years old);
- Diagnosed with kidney cancer, prostate cancer, or bladder cancer;
- whose tumor tissue and associated data are reused as part of the SphéroUro protocol (study outside the Jardé law, retrospective study on tumor tissue and associated data, from the biobank registered with the Ministry of Education and Research under reference No. DC 2016-2677);
- affiliated with a social security health insurance scheme or beneficiary of such a scheme;
- agreeing to participate in the 3DBlood study.
Specific criteria for patients with renal cell carcinoma (RCC):
- Extended nephrectomy (EN) (larger tumor, closer to the sinus; therefore at greater risk of metastasis): with a cavo, cavectomy (neoplastic thrombus in the vena cava), or renal vein bud, or lymph node dissection, or with adrenalectomy (often for tumors, therefore possible metastases).
Or
- Partial nephrectomy (PN): with tumors at stage T2 or T3a)
Exclusion Criteria:
- Patient refusal to participate in the study;
- Inability to provide the subject with informed consent (subject in an emergency situation, difficulties in understanding the subject, etc.);
- Patient under legal protection, guardianship, or conservatorship;
- Patient currently participating in a therapeutic clinical trial (i.e., gene therapy or other).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Constitute and validate a panel of vascularized and perfused 3D tumoroids for personalized medicine based on patient tumors for urological cancers, incorporating autologous immune cells.
Time Frame: Day 1 after surgery
|
For the establishment of the models, it is necessary to have: sufficient cell viability after enzymatic dissociation of the tissues and a correspondence of patient/model 3D therapeutic responses.
The patients' blood will be collected to isolate immune cells using a Ficoll gradient, to integrate them into the forming 3D structures, taking into account the proportion present in the primary tumor tissues of each patient, for the 3D structures developed from their tumor.
|
Day 1 after surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urologic Neoplasms
- Urinary Bladder Diseases
- Prostatic Neoplasms
- Urinary Bladder Neoplasms
- Kidney Neoplasms
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
Other Study ID Numbers
- 9310
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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