- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Translated with DeepL.com (free version)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Hervé LANG, PUPH
- Telefonnummer: 33369550974
- E-post: Herve.Lang@chru-strasbourg.fr
Studieorter
-
-
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Strasbourg, Frankrike, 67091
- Rekrytering
- Service de Chirurgie Urologique _ Hôpitaux Universitaires de Strasbourg
-
Kontakt:
- Hervé LANG, PUPH
- Telefonnummer: 33 3 69 55 09 74
- E-post: herve.lang@chru-strasbourg.fr
-
Huvudutredare:
- Hervé LANG, PUPH
-
Underutredare:
- Nicolas MEYER, PUPH
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
- 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)
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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.
Tidsram: 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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Genitala neoplasmer, manliga
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Genitala sjukdomar, manliga
- Prostatasjukdomar
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Urologiska neoplasmer
- Sjukdomar i urinblåsan
- Prostatiska neoplasmer
- Neoplasmer i urinblåsan
- Neoplasmer i njurarna
- Undersökningstekniker
- Provhantering
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Punktering
- Kirurgiska ingrepp, operativ
- Blodprovsamling
Andra studie-ID-nummer
- 9310
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