Study of Tumor Metabolism by Isotopic Tagging in Patients... | NCT02305056

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

NCT02305056

Sponsor

University Hospital, Grenoble

Status

Terminated

Last Update Posted

May 9, 2018Actual

Enrollment

6Actual

Phase

Phase 1

Conditions

High-grade Glioma

Interventions

C13 N15 Valine

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Jan 30, 2018Actual

Completion Date

Jan 30, 2018Actual

First Submitted Date

Nov 20, 2014

First Submission Date that Met QC Criteria

Dec 1, 2014

First Posted Date

Dec 2, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2018

Last Update Posted Date

May 9, 2018Actual

Name	Class
National Cancer Institute, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Label	Type	Description	Intervention Names
C13 N15 Valine	Experimental	Intervention C13 N15 Valine	Drug: C13 N15 Valine

Name	Type	Description	Arm Group Labels	Other Names
C13 N15 Valine	Drug	C13 N15 Valine administration	C13 N15 Valine	CARBONOMIC

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type