- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04944550
New Models for the Evaluation of Preclinical Treatment for Urothelial Carcinomas of the Upper Excretory Tract. (CICLOP)
Development of New Models for the Evaluation of Preclinical Treatment for Urothelial Carcinomas of the Upper Excretory Tract.
Upper Urinary Tract Urothelial Carcinomas are rare, aggressive tumors, accounting for 5 to 10% of all urothelial tumors. These include tumors which develop in the renal cavities (renal pelvis, calices) and ureteral tumors. Nephro-ureterectomy is the standard treatment but 80% of patients will have a relapse within 2 years. Only one trial has (Birtle et al. 2020), has shown the interest of postoperative chemotherapy. Neoadjuvant systemic treatment seems particularly interesting for a population which is going to undergo a nephronic loss and therefore reduction in kidney function which is likely to make patients ineligible for cisplatin. In favor of additional immunotherapy, it has been described that upper excretory tract tumors have a high immunogenic potential with a high rate of microsatellite instability.
From surgical samples of patient tumors obtained after nephroureterectomy or biopsy material collected before treatment, we are going to generate patient-derived cell lines and xenograft models in the mouse. A recent publication has demonstrated the feasibility of this approach by specifying that the capture rate of tumor cells is 50% for patient-derived xenografts and 25% for patient-derived cells (Coleman et al. 2020). As tumors harvested from biopsies do not grow in patient-derived xenografts,we plan to graft the biopsies onto chorioallantoic chicken embryo membranes, a model which has never been used for this indication and which is one of the original features of our approach. These three concomitant approaches will allow us to increase our chances of obtaining stable upper urinary tract urothelial carcinoma lines to be used for the screening and identification of new treatments or new combinations of molecules that would benefit patients with upper urinary tract urothelial carcinomas, knowing that very few studies dedicated to this type of cancer have been conducted or published due to the rarity of the disease and the lack of existing models published on the subject of these particular tumors.
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Visão geral do estudo
Status
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Contato de estudo
- Nome: Nadine HOUEDE, Pr.
- Número de telefone: +33 4.66.68.33.01
- E-mail: nadine.houede@chu-nimes.fr
Estude backup de contato
- Nome: Anissa MEGZARI, Mme.
- Número de telefone: 04.66.68.42.36
- E-mail: drc@chu-nimes.fr
Locais de estudo
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Gard
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Nîmes, Gard, França, 30029
- Recrutamento
- Centre Hospitalier Universitaire de Nîmes
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Contato:
- Anissa MEZGARI
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Patients treated consecutively at the Urology Andrology Department of Nîmes University Hospital for high grade carcinoma of the pelvis or renal ureter with an indication for total nephroureterectomy decided during a multidisciplinary meeting.
- Patient with a diagnosis of high-grade urothelial carcinoma of the pelvis or renal ureter confirmed by histology (biopsy, biopsy of the ureteroscopic) or by cytology with the presence of :
- High-grade disease on ureteroscopic biopsy OR ;
- High grade disease on urinary cytology AND infiltrating appearance of the renal pelvic wall / ureter on the scanner (the presence of hydronephrosis will be considered as pervasive by definition) with a negative cytoscopy.
Exclusion Criteria:
- Any patient who has undergone previous systemic treatment.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Histological characteristics of patient-derived xenograft models after staining.
Prazo: 1-6 months after harvesting
|
Microscopic observation of cells after staining with hematoxylin and eosin
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1-6 months after harvesting
|
Study of genomes of tumor specimens
Prazo: 1-6 months after harvesting
|
Exome sequencing of DNA cells isolated from original patient tumor specimens.
|
1-6 months after harvesting
|
Alterations in the genomes of patient-derived xenograft tumor models
Prazo: 1-6 months after harvesting
|
Exome sequencing of DNA cells isolated from patient-derived xenograft tumor models.
|
1-6 months after harvesting
|
Alterations in the genomes of patient-derived cell line models
Prazo: 1-6 months after harvesting
|
Exome sequencing of DNA cells isolated from patient-derived cell line models.
|
1-6 months after harvesting
|
Study of the transcriptome of patient tumor specimens.
Prazo: 1-6 months after harvesting
|
RNA-sequencing of cells isolated from patient tumor specimens.
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1-6 months after harvesting
|
Transcriptome of the patient-derived xenograft tumor models.
Prazo: 1-6 months after harvesting
|
RNA-sequencing of cells isolated from patient-derived xenograft tumor models.
|
1-6 months after harvesting
|
Transcriptome of the patient-derived cell line models.
Prazo: 1-6 months after harvesting
|
RNA-sequencing of cells isolated from patient-derived cell line models.
|
1-6 months after harvesting
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Sensitivity to Cisplatin: patient-derived cell line models
Prazo: 6-8 months after harvesting
|
The MIC 50 test (Minimum Inhibitory Concentration required for cell growth to be inhibited by 50%) will be used in vitro to test the tumor cells' response to Cisplatin.
|
6-8 months after harvesting
|
Sensitivity to Carboplatin: patient-derived cell line models
Prazo: 6-8 months after harvesting
|
The MIC 50 test (Minimum Inhibitory Concentration required for cell growth to be inhibited by 50%) will be used in vitro to test the tumor cells' response to Carboplatin.
|
6-8 months after harvesting
|
Sensitivity to Oxaliplatin: patient-derived cell line models
Prazo: 6-8 months after harvesting
|
The MIC 50 test (Minimum Inhibitory Concentration required for cell growth to be inhibited by 50%) will be used in vitro to test the tumor cells' response to Oxaliplatin.
|
6-8 months after harvesting
|
Sensitivity to Gemcitabin: patient-derived cell line models
Prazo: 6-8 months after harvesting
|
The MIC 50 test (Minimum Inhibitory Concentration required for cell growth to be inhibited by 50%) will be used in vitro to test the tumor cells' response to Gemcitabin.
|
6-8 months after harvesting
|
Tumor size in non-treated patient-derived xenograft models
Prazo: 1-6 months after harvesting
|
The volume of tumors will be measured in mm3.
|
1-6 months after harvesting
|
Sensitivity to Cisplatin: tumor size in treated patient-derived xenograft models
Prazo: 6-8 months after harvesting
|
To test the tumor cells' response to Cisplatin in xenograft models, the volume of tumors will be measured in mm3 and compared with the volume of tumors in the non-treated control group.
|
6-8 months after harvesting
|
Sensitivity to Cisplatin: tumor growth rate in patient-derived xenograft models
Prazo: 6-8 months after harvesting
|
To test the tumor cells' response to Cisplatin in xenograft models, the Tumor Growth Inhibition index, which is defined as (1 - (mean volume of treated tumors)/(mean volume of control tumors)) × 100% will be used.
|
6-8 months after harvesting
|
Sensitivity to Carboplatin: tumor size in treated patient-derived xenograft models
Prazo: 6-8 months after harvesting
|
To test the tumor cells' response to Carboplatin in xenograft models, the volume of tumors will be measured in mm3 and compared with the volume of tumors in the non-treated control group.
|
6-8 months after harvesting
|
Sensitivity to Carboplatin: tumor growth rate in treated patient-derived xenograft models
Prazo: 6-8 months after harvesting
|
To test the tumor cells' response to Carboplatin in xenograft models, the Tumor Growth Inhibition index, which is defined as (1 - (mean volume of treated tumors)/(mean volume of control tumors)) × 100% will be used.
|
6-8 months after harvesting
|
Sensitivity to Oxiplatin: tumor size in treated patient-derived xenograft models
Prazo: 6-8 months after harvesting
|
To test the tumor cells' response to Oxiplatin in xenograft models, the volume of tumors will be measured in mm and compared with the volume of tumors in the non-treated control group.
|
6-8 months after harvesting
|
Sensitivity to Oxiplatin: tumor growth rate in treated patient-derived xenograft models
Prazo: 6-8 months after harvesting
|
To test the tumor cells' response to Oxiplatin in xenograft models, the Tumor Growth Inhibition index, which is defined as (1 - (mean volume of treated tumors)/(mean volume of control tumors)) × 100% will be used.
|
6-8 months after harvesting
|
Sensitivity to Gemcitabine: tumor size in treated patient-derived xenograft models
Prazo: 6-8 months after harvesting
|
To test the tumor cells' response to Gemcitabine in xenograft models, the tumor volume will be measured in mm3 and compared with the volume of tumors in the non-treated control group.
|
6-8 months after harvesting
|
Sensitivity to Gemcitabin: tumor growth rate in treated patient-derived xenograft models
Prazo: 6-8 months after harvesting
|
To test the tumor cells' response to Gemcitabin in xenograft models, the Tumor Growth Inhibition index, which is defined as (1 - (mean volume of treated tumors)/(mean volume of control tumors)) × 100% will be used.
|
6-8 months after harvesting
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Patients' gender
Prazo: Day 0
|
The sex of patients will be recorded at the inclusion as Male/Female/Transgender
|
Day 0
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Patients' age
Prazo: Day 0
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The age of patients will be recorded at the inclusion in years
|
Day 0
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Primitive tumor site
Prazo: Day 0
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The site of the patient's primitive tumor will be recorded at the inclusion
|
Day 0
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Infiltrative tumor
Prazo: Day 0
|
The tumor will be noted as infiltrative or not (YES/NO) at the inclusion.
|
Day 0
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nadine HOUEDE, Pr., Chu de Nimes
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NIMAO/2020-2/NH01
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