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

May 3, 2018 updated by: University Hospital, Grenoble
The purpose of the study is to follow tumoral proteins metabolism by in vivo no radioactive isotopic tagging (carbon 13 and nitrogen 15).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • CLINATEC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • No valid inclusion criteria
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C13 N15 Valine
Intervention C13 N15 Valine
Drug: C13 N15 Valine
C13 N15 Valine administration
Other Names:
  • CARBONOMIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mass spectrometry measurement of C13 labelled proteins
Time Frame: during 30 hours
during 30 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

National Cancer Institute, France

Investigators

  • Principal Investigator: François BERGER, Pr, university grenoble hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

January 30, 2018

Study Completion (Actual)

January 30, 2018

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARBONOMIC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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