Study of Tumor Metabolism by Isotopic Tagging in Patients With High-grade Glioma (CARBONOMIC)

NCT ID: NCT02305056

Last Updated: 2018-05-09

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-01-30

Brief Summary

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The purpose of the study is to follow tumoral proteins metabolism by in vivo no radioactive isotopic tagging (carbon 13 and nitrogen 15).

Detailed Description

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The project aims to study protein turnover in glioblastoma using mass spectrometry after 13C-valine incorporation. This will allow to identify proteins in circulation secreted by tumor which could be diagnostic and pronostic biomarkers in patients With High-grade Glioma.

Conditions

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High-grade Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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C13 N15 Valine

Intervention C13 N15 Valine

Group Type EXPERIMENTAL

C13 N15 Valine

Intervention Type DRUG

C13 N15 Valine administration

Interventions

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C13 N15 Valine

C13 N15 Valine administration

Intervention Type DRUG

Other Intervention Names

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CARBONOMIC

Eligibility 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
* High-grade Glioma tumor suspicion
* Resective surgery indication
* 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

* 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
* Karnofsky score \< 40%
* Weight \> 100 kg
* No possibility of resective surgery

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
* Precedent complete macroscopic tumor resective surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François BERGER, Pr

Role: PRINCIPAL_INVESTIGATOR

University Grenoble Hospital

Locations

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CLINATEC

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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CARBONOMIC

Identifier Type: -

Identifier Source: org_study_id

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