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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02648100
Other study ID # NI 13021
Secondary ID
Status Recruiting
Phase N/A
First received January 5, 2016
Last updated June 19, 2017
Start date March 2014
Est. completion date December 2019

Study information

Verified date June 2017
Source Assistance Publique - Hôpitaux de Paris
Contact Yves ALLORY, MD, PhD
Phone (0)1 49 81 27 29
Email yves.allory@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Muscle invasive (MIBC) and/or metastatic bladder cancer is associated with poor prognosis and no target therapies for this pathology are currently validated. By 40 gene expression signature realized on frozen samples, we have previously identified an aggressive sub-class of MIBC, called basal. This sub-class (20% of MIBC) showed strong EGFR dependence in vitro and in vivo (Rebouissou et al. Science Translational Medicine 2014). This observation suggests a possible response to EGFR targeted therapy in patients of this subgroup. Our aim is to establish a standard diagnostic tool to differentiate the basal subtype of bladder cancer and evaluate the effect of anti-EGFR therapy, by analyzing previous clinical trial (GETUG19) and preclinical models, which compare the classical chemotherapy to anti-EGFR associated chemotherapy.


Description:

The aim of this study is:

1. To validate a diagnostic test for formalin-fixed paraffin-embedded (FFPE) samples by Nanostring technology, using the 40 genes signature as reference. First, we will compare frozen and FFPE tissues (n=120), to establish a transcriptional signature in FFPE samples. Secondly, to further characterize basal subtype of bladder cancer, we will study the mutational and gain/loss landscape and immunohistochemistry markers in a new series of tumors after classifying them by our gene signature (n=510). These characteristics will be included in a new signature by defining the optimal prediction discrimination AIC et Net Reclassification Index.

2. To assess the prognosis after cisplatine treatment in 510 patients treated by cystectomy with or without adjuvant chemotherapy (pT2/pT3/pT4, N0 or N+) and in another multicentric series of 188 patients treated by cystectomy and adjuvant chemotherapy (pT3/pT4 et/ou N+). Uni and multi variant analysis will be realized by adjusted Cox model, and the added value of basal subtype as compared to standard prognostic factors will be evaluated. The propensity score will be realized to assess the association of basal subtype and response to chemotherapy. The anti-EGFR response will be analyzed in the clinical trial GETUG19 which uses Panitumumab in patients with metastatic urothelial carcinomas (n=93)

3. To study the treatment response in preclinical models. We characterized previously preclinical murine models derived from xenografts of MIBC (n=14 and new xenografts will be added). We will study the effect of anti-EGFR alone or in combination with chemotherapy in basal and non basal subtypes of xenografts.

By this study we will be able to better characterize the basal subtype of bladder cancer and confirm its aggressive behaviour as compared to other subtypes of MIBC. These results will further help to establish new clinical trials which include anti-EGFR in patients of basal subtype.


Recruitment information / eligibility

Status Recruiting
Enrollment 911
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

Muscle invasive bladder cancer Treatment by cystectomy Adjuvant chemotherapy for 3rd cohort Clinical trial GETUG 19 for 4th cohort

Exclusion Criteria:

FFPE material not available Follow-up data not available

Study Design


Intervention

Other:
biomarker study


Locations

Country Name City State
France Henri Mondor Hospital Creteil

Sponsors (6)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris INSERM (French National Medicine Research Agency), Institut Curie, Ministry of Health, France, National Cancer Institute, France, Paris 12 Val de Marne University

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival 5 years
Secondary Overall survival 5 years
Secondary Specific survival 5 years
See also
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Terminated NCT02716896 - Radical Cystectomy Compared With Chemoradiation for Muscle Invasive Bladder Cancer N/A
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Terminated NCT03397394 - Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Phase 2
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Recruiting NCT04813107 - A Study to Evaluate the Safety and Efficacy of Oral APL-1202 in Combination With Tislelizumab Compared to Tislelizumab Alone as Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer Phase 1/Phase 2
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Recruiting NCT04960709 - Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin Phase 3
Not yet recruiting NCT05860543 - Clinical Performance Evaluation of the C2i Test
Recruiting NCT05979740 - RC48 Combined With Toripalimab and Radiotherapy for Bladder Sparing Treatment in MIBC Phase 2
Active, not recruiting NCT04053101 - Role of FDG-PET CT in the Management of Muscle Invasive Bladder Cancer