Upper Urinary Tract Urothelial CarcinomaCICLOPNCT04944550
New Models for the Evaluation of Preclinical Treatment for Urothelial Carcinomas of the Upper Excretory Tract.
An observational study of Upper Urinary Tract Urothelial Carcinoma and Nephroureterectomy, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Urinary Tract Urothelial Carcinoma, Nephroureterectomy, Tumor
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population consists of patients treated consecutively at the Urology Andrology department of Nîmes University Hospital for high-grade carcinomas of the pelvis or renal ureter for whom a total nephroureterectomy has been indicated during a multidisciplinary meeting. The tumor samples used for our study come from specimens removed surgically. Patients must not have undergone any prior systemic treatment.
Who may be able to join
- 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.
Who cannot join
- Any patient who has undergone previous systemic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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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- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological characteristics of patient-derived xenograft models after staining.
Microscopic observation of cells after staining with hematoxylin and eosin
Measured: 1-6 months after harvesting
Study of genomes of tumor specimens
Exome sequencing of DNA cells isolated from original patient tumor specimens.
Measured: 1-6 months after harvesting
Alterations in the genomes of patient-derived xenograft tumor models
Exome sequencing of DNA cells isolated from patient-derived xenograft tumor models.
Measured: 1-6 months after harvesting
Alterations in the genomes of patient-derived cell line models
Exome sequencing of DNA cells isolated from patient-derived cell line models.
Measured: 1-6 months after harvesting
Study of the transcriptome of patient tumor specimens.
RNA-sequencing of cells isolated from patient tumor specimens.
Measured: 1-6 months after harvesting
Transcriptome of the patient-derived xenograft tumor models.
RNA-sequencing of cells isolated from patient-derived xenograft tumor models.
Measured: 1-6 months after harvesting
Transcriptome of the patient-derived cell line models.
RNA-sequencing of cells isolated from patient-derived cell line models.
Measured: 1-6 months after harvesting
Secondary outcomes (13)
Sensitivity to Cisplatin: patient-derived cell line models
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.
Measured: 6-8 months after harvesting
Sensitivity to Carboplatin: patient-derived cell line models
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.
Measured: 6-8 months after harvesting
Sensitivity to Oxaliplatin: patient-derived cell line models
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.
Measured: 6-8 months after harvesting
Sensitivity to Gemcitabin: patient-derived cell line models
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.
Measured: 6-8 months after harvesting
Tumor size in non-treated patient-derived xenograft models
The volume of tumors will be measured in mm3.
Measured: 1-6 months after harvesting
Sensitivity to Cisplatin: tumor size in treated patient-derived xenograft models
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.
Measured: 6-8 months after harvesting
Sensitivity to Cisplatin: tumor growth rate in patient-derived xenograft models
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.
Measured: 6-8 months after harvesting
Sensitivity to Carboplatin: tumor size in treated patient-derived xenograft models
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.
Measured: 6-8 months after harvesting
Sensitivity to Carboplatin: tumor growth rate in treated patient-derived xenograft models
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.
Measured: 6-8 months after harvesting
Sensitivity to Oxiplatin: tumor size in treated patient-derived xenograft models
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.
Measured: 6-8 months after harvesting
Sensitivity to Oxiplatin: tumor growth rate in treated patient-derived xenograft models
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.
Measured: 6-8 months after harvesting
Sensitivity to Gemcitabine: tumor size in treated patient-derived xenograft models
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.
Measured: 6-8 months after harvesting
Sensitivity to Gemcitabin: tumor growth rate in treated patient-derived xenograft models
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.
Measured: 6-8 months after harvesting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Mar 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Urinary Tract Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM U1194, Institut de Recherche en Cancérologie de Montpellier, Campus Val d'Aurelle, 34298 Montpellier cedex 5
- Responsible party
- Sponsor
- Investigators
- Nadine HOUEDE, Pr., Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944550
- Sponsor's protocol ID
- NIMAO/2020-2/NH01
- Acronym
- CICLOP
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2021
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Birtle A, Johnson M, Chester J, Jones R, Dolling D, Bryan RT, Harris C, Winterbottom A, Blacker A, Catto JWF, Chakraborti P, Donovan JL, Elliott PA, French A, Jagdev S, Jenkins B, Keeley FX Jr, Kockelbergh R, Powles T, Wagstaff J, Wilson C, Todd R, Lewis R, Hall E. Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, open-label, randomised controlled trial. Lancet. 2020 Apr 18;395(10232):1268-1277. doi: 10.1016/S0140-6736(20)30415-3. Epub 2020 Mar 5.
PubMed 32145825
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of New Models for the Evaluation of Preclinical Treatment for Urothelial Carcinomas of the Upper Excretory Tract.
- ClinicalTrials.gov ID
- NCT04944550
- Acronym / sponsor ID
- CICLOP / NIMAO/2020-2/NH01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- INSERM U1194, Institut de Recherche en Cancérologie de Montpellier, Campus Val d'Aurelle, 34298 Montpellier cedex 5
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients treated consecutively at the Urology Andrology department of Nîmes University Hospital for high-grade carcinomas of the pelvis or renal ureter for whom a total nephroureterectomy has been indicated during a multidisciplinary meeting. The tumor samples used for our study come from specimens removed surgically. Patients must not have undergone any prior systemic treatment.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Any patient who has undergone previous systemic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Histological characteristics of patient-derived xenograft models after staining.
Time frame: 1-6 months after harvesting
Microscopic observation of cells after staining with hematoxylin and eosin
Study of genomes of tumor specimens
Time frame: 1-6 months after harvesting
Exome sequencing of DNA cells isolated from original patient tumor specimens.
Alterations in the genomes of patient-derived xenograft tumor models
Time frame: 1-6 months after harvesting
Exome sequencing of DNA cells isolated from patient-derived xenograft tumor models.
Alterations in the genomes of patient-derived cell line models
Time frame: 1-6 months after harvesting
Exome sequencing of DNA cells isolated from patient-derived cell line models.
Study of the transcriptome of patient tumor specimens.
Time frame: 1-6 months after harvesting
RNA-sequencing of cells isolated from patient tumor specimens.
Transcriptome of the patient-derived xenograft tumor models.
Time frame: 1-6 months after harvesting
RNA-sequencing of cells isolated from patient-derived xenograft tumor models.
Transcriptome of the patient-derived cell line models.
Time frame: 1-6 months after harvesting
RNA-sequencing of cells isolated from patient-derived cell line models.
13 secondary outcomes
Sensitivity to Cisplatin: patient-derived cell line models
Time frame: 6-8 months after harvesting
Sensitivity to Carboplatin: patient-derived cell line models
Time frame: 6-8 months after harvesting
Sensitivity to Oxaliplatin: patient-derived cell line models
Time frame: 6-8 months after harvesting
Sensitivity to Gemcitabin: patient-derived cell line models
Time frame: 6-8 months after harvesting
Tumor size in non-treated patient-derived xenograft models
Time frame: 1-6 months after harvesting
Sensitivity to Cisplatin: tumor size in treated patient-derived xenograft models
Time frame: 6-8 months after harvesting
Sensitivity to Cisplatin: tumor growth rate in patient-derived xenograft models
Time frame: 6-8 months after harvesting
Sensitivity to Carboplatin: tumor size in treated patient-derived xenograft models
Time frame: 6-8 months after harvesting
Sensitivity to Carboplatin: tumor growth rate in treated patient-derived xenograft models
Time frame: 6-8 months after harvesting
Sensitivity to Oxiplatin: tumor size in treated patient-derived xenograft models
Time frame: 6-8 months after harvesting
Sensitivity to Oxiplatin: tumor growth rate in treated patient-derived xenograft models
Time frame: 6-8 months after harvesting
Sensitivity to Gemcitabine: tumor size in treated patient-derived xenograft models
Time frame: 6-8 months after harvesting
Sensitivity to Gemcitabin: tumor growth rate in treated patient-derived xenograft models
Time frame: 6-8 months after harvesting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 32145825Birtle A, Johnson M, Chester J, Jones R, Dolling D, Bryan RT, Harris C, Winterbottom A, Blacker A, Catto JWF, Chakraborti P, Donovan JL, Elliott PA, French A, Jagdev S, Jenkins B, Keeley FX Jr, Kockelbergh R, Powles T, Wagstaff J, Wilson C, Todd R, Lewis R, Hall E. Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, open-label, randomised controlled trial. Lancet. 2020 Apr 18;395(10232):1268-1277. doi: 10.1016/S0140-6736(20)30415-3. Epub 2020 Mar 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadine HOUEDE, Pr. principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Urinary Tract Urothelial Carcinoma and Nephroureterectomy, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological characteristics of patient-derived xenograft models after staining. (time frame: 1-6 months after harvesting). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04944550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.