Multicenter Safety Trial Assessing an Innovative Tumor Molecular and Cellular Print Medical Device in Glioma
ProTool
Molecular and Cellular Print Medical Device Validation in Adult Glioma Tumors
1 other identifier
interventional
150
1 country
5
Brief Summary
The purpose of the study is to determine the clinical safety and operability of the innovative tissue imprint device ProTool.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Oct 2013
Longer than P75 for early_phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 10, 2013
CompletedFirst Posted
Study publicly available on registry
March 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 25, 2020
March 1, 2020
6.7 years
October 10, 2013
March 24, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
2 hours after surgery
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
one month after surgery
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
3 months after surgery
Secondary Outcomes (1)
Molecular measurements in intra-operative cellular samples : transcriptome, micro-RNA, proteome and cellular cultur analysis
up to 1 month after surgery
Study Arms (1)
ProTool
EXPERIMENTALDevice: Brain Tissue Imprint - Medical Device (ProTool)
Interventions
genomic, transcriptomic and proteomic studies.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Grenoblelead
- MEDIMPRINTcollaborator
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
Study Sites (5)
Angers University Hospital
Angers, France
Henri Mondor University Hospital
Créteil, France
CLINATEC
Grenoble, 38000, France
Grenoble University Hospital
Grenoble, 38000, France
Sainte-Anne Hospital
Paris, 75000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François BERGER, MD, PhD
University Grenoble Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2013
First Posted
March 4, 2014
Study Start
October 1, 2013
Primary Completion
June 1, 2020
Study Completion
December 1, 2020
Last Updated
March 25, 2020
Record last verified: 2020-03