Glioma : Oligodendroglioma or AstrocytomaEarly Phase 1ProToolNCT02077543
Multicenter Safety Trial Assessing an Innovative Tumor Molecular and Cellular Print Medical Device in Glioma
A Early Phase 1 study testing Brain Tissue Imprint - Medical Device (ProTool) in people with Glioma : Oligodendroglioma or Astrocytoma, run by University Hospital, Grenoble at 5 sites in France.
Trial summary
The purpose of the study is to determine the clinical safety and operability of the innovative tissue imprint device ProTool. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioma : Oligodendroglioma or Astrocytoma
- What is being tested?
- Brain Tissue Imprint - Medical Device (ProTool)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesFrance
- Study dates
- Oct 2013to Dec 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
François BERGER, MD, PhD contact
Clinical Research Department contact
5 sites in 1 country
France5 sites, 4 recruiting
- Not yet recruiting
Angers University Hospital
Angers
Philippe MENEI, MD, PhD
Caroline, PhD, ArcPromoteur@chu-grenoble.fr
- Not yet recruiting
Henri Mondor University Hospital
Créteil
Stéphane PALFI, MD, PhD
ArcPromoteur@chu-grenoble.fr
- Active, not recruiting
CLINATEC
Grenoble, 38000
- Recruiting
Grenoble University Hospital
Grenoble, 38000
Emmanuel GAY, MD, PhD, EGay@chu-grenoble.fr
PhD, ArcPromoteur@chu-grenoble.fr
- Not yet recruiting
Sainte-Anne Hospital
Paris, 75000
Bertrand DEVAUX, Pr
PhD, ArcPromoteur@chu-grenoble.fr
About this study
Official title: Molecular and Cellular Print Medical Device Validation in Adult Glioma Tumors
The purpose of the study is to determine the clinical safety and operability of the innovative tissue imprint device ProTool.
Read the detailed description
Current limitations in the management of high grade brain tumors partly reside in the lack of access to pathological tissue.
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.
- Being tested
- Brain Tissue Imprint - Medical Device (ProTool)
- Medical subject headings
- Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Tissue Imprint - Medical Device (ProTool)Device
genomic, transcriptomic and proteomic studies.
| Study group | Role | What they receive |
|---|---|---|
| ProTool | Experimental | Device: Brain Tissue Imprint - Medical Device (ProTool) Receives: Device: Brain Tissue Imprint - Medical Device (ProTool) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
Measured: 2 hours after surgery
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
Measured: one month after surgery
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
Measured: 3 months after surgery
Secondary outcomes (1)
Molecular measurements in intra-operative cellular samples : transcriptome, micro-RNA, proteome and cellular cultur analysis
Measured: up to 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startOct 2013
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma : Oligodendroglioma or AstrocytomaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- MEDIMPRINT, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- François BERGER, MD, PhD, Principal investigator, University Grenoble Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077543
- Sponsor's protocol ID
- ProTool
- Acronym
- ProTool
- Status last verified
- Mar 2020
- First submitted
- 10 Oct 2013
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Cellular Print Medical Device Validation in Adult Glioma Tumors
- ClinicalTrials.gov ID
- NCT02077543
- Acronym / sponsor ID
- ProTool / ProTool
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- MEDIMPRINT, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Oct 2013
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the clinical safety and operability of the innovative tissue imprint device ProTool.
Detailed description
Current limitations in the management of high grade brain tumors partly reside in the lack of access to pathological tissue.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ProTool | Experimental | Device: Brain Tissue Imprint - Medical Device (ProTool)Device: Brain Tissue Imprint - Medical Device (ProTool) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Tissue Imprint - Medical Device (ProTool)genomic, transcriptomic and proteomic studies. | Device | ProTool |
Primary outcome
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
Time frame: 2 hours after surgery
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
Time frame: one month after surgery
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
Time frame: 3 months after surgery
1 secondary outcome
Molecular measurements in intra-operative cellular samples : transcriptome, micro-RNA, proteome and cellular cultur analysis
Time frame: up to 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François BERGER, MD, PhD contact
Clinical Research Department contact
François BERGER, MD, PhD principal investigator
University Grenoble Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Brain Tissue Imprint - Medical Device (ProTool) in people with Glioma : Oligodendroglioma or Astrocytoma, run by University Hospital, Grenoble at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François BERGER, MD, PhD (francois.berger@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma (time frame: 2 hours after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.