Multicenter Safety Trial Assessing an Innovative Tumor Molecular and Cellular Print Medical Device in Glioma
NCT ID: NCT02077543
Last Updated: 2020-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
150 participants
INTERVENTIONAL
2013-10-31
2020-12-31
Brief Summary
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Detailed Description
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Conventional biopsy devices can cause severe side effects, thus limiting the amount of tissue that can be collected for molecular characterization. The Brain-Tissue-Imprint Devices evaluated in this trial offers a unique opportunity to perform multiple non-lesion sampling in both tumor tissue and peritumoral areas. The approach relies on the use of tailored silicon chips integrated in surgical devices enabling tissue sampling through a brief "silicon to tissue contact", thus limiting potential side effects, and opening a way to extensive molecular investigation of brain tumors and their microenvironment.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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ProTool
Device: Brain Tissue Imprint - Medical Device (ProTool)
Brain Tissue Imprint - Medical Device (ProTool)
genomic, transcriptomic and proteomic studies.
Interventions
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Brain Tissue Imprint - Medical Device (ProTool)
genomic, transcriptomic and proteomic studies.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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MEDIMPRINT
UNKNOWN
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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François BERGER, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Grenoble Hospital
Locations
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Angers University Hospital
Angers, , France
Henri Mondor University Hospital
Créteil, , France
CLINATEC
Grenoble, , France
Grenoble University Hospital
Grenoble, , France
Sainte-Anne Hospital
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Philippe MENEI, MD, PhD
Role: primary
Stéphane PALFI, MD, PhD
Role: primary
Role: backup
Bertrand DEVAUX, Pr
Role: primary
Other Identifiers
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ProTool
Identifier Type: -
Identifier Source: org_study_id
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