NCT02648100

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
911

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

5.8 years

First QC Date

January 5, 2016

Last Update Submit

June 19, 2017

Conditions

Muscle Invasive Bladder CancerMolecular Taxonomy

Keywords

Muscle invasive bladder cancerBasal subtypeAnti-EGFR treatmentNanostring

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    5 years

Secondary Outcomes (2)

  • Overall survival

    5 years

  • Specific survival

    5 years

Study Arms (4)

A

120 patients from Carte d'Identité des Tumeurs (CIT), Henri Mondor and Foch hospitals.

Other: biomarker study

B

510 cystectomy patients operated between 2005 and 2010 in Henri Mondor and Foch hospitals.

Other: biomarker study

C

188 patients treated by cystectomy and adjuvant chemotherapy for locally advanced bladder cancer from a national multicentric study.

Other: biomarker study

D

93 patients from the clinical trial GETUG 19 (UNICANCER)

Other: biomarker study

Interventions

biomarker studyOTHER
ABCD

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Bladder Cancer from 4 cohorts * 2 observational cohorts of patients with muscle invasive bladder cancer (all stages) from two Henri Mondor (Créteil) and Foch (Suresnes) hospitals * 1 multicentric observational cohort of patients with locally advanced muscle invasive bladder cancer trated by adjuvantchemotherapy after cystectomy * 1 clinical trial GETUG 19 (MVAC + panitumumab)

You may qualify if:

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

You may not qualify if:

  • FFPE material not available Follow-up data not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue : frozen (n=120), FFPE (n=911)

Study Officials

  • Yves ALLORY, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yves ALLORY, MD, PhD

CONTACT

(0)1 49 81 27 29yves.allory@aphp.fr

François RADVANYI, PhD

CONTACT

(0)1 42 34 63 39francois.radvanyi@curie.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 6, 2016

Study Start

March 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

June 20, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

Locations

FR(1)