NCT02473484

Brief Summary

The aim is to classify high grade glioma by matrix-assisted laser desorption/ionization mass spectrometry imaging (MALDI MSI). In order to provide more specific informations for the diagnosis and the prognosis of high grade glioma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

December 22, 2017

Status Verified

December 1, 2017

Enrollment Period

3.3 years

First QC Date

June 12, 2015

Last Update Submit

December 21, 2017

Conditions

Glioblastoma

Keywords

High Grade GliomaProteomicsMALDI-MSI

Outcome Measures

Primary Outcomes (1)

  • To evaluate the correlation between the WHO classification 2007 only established standard diagnostic and classification by mass spectrometry gliomas (lipids, peptides, proteins)

    2.5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

high grade glioma

You may qualify if:

  • Patients with grade III or IV glioma newly diagnosed with histological evidence
  • Surgical indication
  • Tumor tissue available at biobank of Lille
  • Men and women aged ≥ 18 years
  • Informed Consent signed by the patient or his legal representative.

You may not qualify if:

  • Antecedents of other cancers except basal cell skin cancer or carcinoma in situ of the uterus cervix
  • Previous history of brain radiotherapy
  • Anti-tumor systemic treatments (chemotherapy or targeted therapy) prior to surgery of glioma
  • Genetic disease that may cause brain tumor, potentially radiation-induced tumor
  • History of degenerative neurological disease prior to diagnosis
  • contraindication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Le Rhun

Lille, 59000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

tumoral DNA

MeSH Terms

Conditions

GlioblastomaGlioma

Condition Hierarchy (Ancestors)

AstrocytomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Emilie Le RHUN, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 16, 2015

Study Start

June 24, 2014

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

December 22, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)