NCT03630861

Brief Summary

MIRNA is a prospective multi-center observational study designed to explore 762 plasma microRNAs in patients with malignant CNS tumours: 60 primary glioblastoma (GBM), 20 primary CNS lymphomas and 40 brain metastases in an attempt to establish plasma microRNA signatures specific to GBM capable of distinguishing them from malignant non-glial brain tumours. 20 patients with cerebral stroke and 20 healthy volunteers will also participate in the study, and for each patient, a panel of 762 microRNAs will be screened in plasma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

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

January 10, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2017

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
Last Updated

August 15, 2018

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

April 10, 2018

Last Update Submit

August 10, 2018

Conditions

Brain Tumors

Keywords

MicroRNAsGlioblastomanonglial tumorsstrokediagnosis

Outcome Measures

Primary Outcomes (1)

  • QR (relative amount)

    QR (relative amount) of each plasma microRNA for GBM and non-glial tumors (PCNSL, BM).

    Up to 3 months after the end of all samplings.

Secondary Outcomes (3)

  • QR value of each microRNA for all groups

    Up to 3 months after the end of all samplings

  • Genetic abnormalities

    Up to 3 months after the end of the study

  • Main imaging and anatomopathology characteristics

    Up to 3 months after the end of the study

Study Arms (5)

GBM

Primary glioblastoma (GBM)

PCNSL

Primary CNS lymphomas (PCNSL)

Brain metastases

Brain metastases (BM)

Cerebral Stroke

Cerebral Stroke (CS)

Healthy Volunteers

Healthy Volunteers (HV)

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Brain tumors: GBM, PCNSL, BM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum samples aliquoted and stored may be used either for re-analysis if necessary for the current study or as part

MeSH Terms

Conditions

Brain NeoplasmsGlioblastomaStrokeDisease

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

April 10, 2018

First Posted

August 15, 2018

Study Start

January 10, 2016

Primary Completion

October 5, 2017

Study Completion

November 1, 2017

Last Updated

August 15, 2018

Record last verified: 2018-04

Locations

FR(1)