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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02077543 |
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Date of registration:
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10/10/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Multicenter Safety Trial Assessing an Innovative Tumor Molecular and Cellular Print Medical Device in Glioma
ProTool |
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Scientific title:
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Molecular and Cellular Print Medical Device Validation in Adult Glioma Tumors |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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150 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02077543 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Early Phase 1
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Countries of recruitment
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France
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Contacts
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Name:
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François BERGER, MD, PhD |
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Address:
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Telephone:
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Email:
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francois.berger@inserm.fr |
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Affiliation:
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Name:
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François BERGER, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Grenoble Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Glioma : Oligodendroglioma or Astrocytoma
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Intervention(s)
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Device: Brain Tissue Imprint - Medical Device (ProTool)
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Primary Outcome(s)
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Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
[Time Frame: 3 months after surgery]
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Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
[Time Frame: one month after surgery]
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Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
[Time Frame: 2 hours after surgery]
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Secondary Outcome(s)
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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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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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