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Multicenter Safety Trial Assessing an Innovative Tumor Molecular and Cellular Print Medical Device in Glioma (ProTool)

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ClinicalTrials.gov Identifier: NCT02077543
Recruitment Status : Recruiting
First Posted : March 4, 2014
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
The purpose of the study is to determine the innocuity and operability of the innovative tumor molecular and cellular print ProTool.

Condition or disease Intervention/treatment Phase
Glioma : Oligodendroglioma or Astrocytoma Device: Molecular and cellular tumor print Medical Device (ProTool) Phase 1

Detailed Description:
Diagnostic in cancerology keeps based on biopsy or exeresis tissues anatomopathologic analysis. Micro-invasive biopsy approaches reduces chirurgical aggressivity but also tissue amount The innovative Medical Device ProTool offers a micro-invasive biopsy approach in parallel with classical chirurgical proceeding. It allows to complete heterogeneity tumoral analysis and peri-tumoral tissue environment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Molecular and Cellular Print Medical Device Validation in Adult Glioma Tumors
Study Start Date : October 2013
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ProTool
Device: Molecular and cellular tumor print Medical Device (ProTool)
Device: Molecular and cellular tumor print Medical Device (ProTool)
Proteomic, genomic and cellular culture




Primary Outcome Measures :
  1. Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma [ Time Frame: 2 hours after surgery ]
  2. Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma [ Time Frame: one month after surgery ]
  3. Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma [ Time Frame: 3 months after surgery ]

Secondary Outcome Measures :
  1. Molecular measurements in intra-operative cellular samples : transcriptome, micro-RNA, proteome and cellular cultur analysis [ Time Frame: up to 1 month after surgery ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • more or equal than 18 years old
  • patient affiliated to social security or similarly regime
  • informed consent form signed
  • glial tumor suspicion
  • Stereotaxic biopsy indication
  • Karnofsky score > 70%
  • Hematological assessment :
  • neutrophils > 1500/mm3
  • Platelet > 150 000
  • blood Creatinin normal
  • alkaline Phosphatases and transaminases no more than two times normal
  • Bilirubin < 1.5 times normal

Exclusion Criteria:

  • Pregnant women and lactating mothers
  • Ward of court or under guardianship
  • Adult unable to express their consent
  • Person deprived of freedom by judicial or administrative decision
  • Person hospitalized without their consent
  • Person under legal protection
  • Person participating in another clinical study
  • Intratumoral hemorrhage MRI detected
  • Treatment anticoagulant or antisludge treatments
  • Active Infections and non controled or medical affection or psychiatric intercurrent non treated
  • Evolutive cerebral oedema without corticoid response
  • Non controled Epilepsy without antiepileptics response
  • Susceptibility to Medical Device materials allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077543


Contacts
Contact: François BERGER, MD, PhD + 33 4 38 78 15 18 francois.berger@cea.fr
Contact: Caroline SANDRE-BALLESTER, PhD + 33 4 38 78 28 51 csandreballester@chu-grenoble.fr

Locations
France
Angers University Hospital Not yet recruiting
Angers, France
Contact: Philippe MENEI, MD, PhD         
Contact: Caroline SANDRE-BALLESTER, PhD    +33 4 38 78 28 51      
Principal Investigator: Philippe MENEI, Pr         
Henri Mondor University Hospital Not yet recruiting
Creteil, France
Contact: Stéphane PALFI, MD, PhD         
Contact: Caroline SANDRE-BALLESTER, PhD    +33 4 38 78 28 51    csandreballester@chu-grenoble.fr   
Principal Investigator: Stéphane PALFI, Pr         
CLINATEC Recruiting
Grenoble, France, 38000
Contact: François , MD, PhD       francois.berger@cea.fr   
Contact: Caroline SANDRE-BALLESTER, PhD       csandreballester@chu-grenoble.fr   
Principal Investigator: François BERGER, MD, PhD         
Grenoble University Hospital Recruiting
Grenoble, France, 38000
Contact: Emmanuel GAY, MD, PhD       EGay@chu-grenoble.fr   
Contact: Caroline SANDRE-BALLESTER, PhD    +33 4 38 78 28 51    csandreballester@chu-grenoble.fr   
Principal Investigator: Emmanuel GAY, Pr         
Sainte-Anne Hospital Not yet recruiting
Paris, France, 75000
Contact: Bertrand DEVAUX, Pr         
Contact: Caroline SANDRE-BALLESTER, PhD    +33 4 38 78 28 51    csandreballester@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: François BERGER, MD, PhD University Grenoble Hospital

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02077543     History of Changes
Other Study ID Numbers: ProTool
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Glioma
Astrocytoma
Oligodendroglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue