NCT04461002

Brief Summary

From the medical records of a series of patients operated on for incident grade II and III glioma, the primary objective is to evaluate the correlation between the molecular profile of tumours and preoperative imaging data (by FDG and FDOPA PET-scan and multimodal MRI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 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

September 30, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

4.8 years

First QC Date

July 2, 2020

Last Update Submit

July 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary outcome

    Evaluate the correlation between tumour molecular profile and preoperative imaging data (FDG and FDOPA PET-scan and multimodal MRI).

    4 years

Secondary Outcomes (2)

  • Molecular profile

    4years

  • Imaging data

    4 years

Study Arms (1)

Cohort

Retrospective cohort

Other: Retrospective analysis

Interventions

Evaluate the correlation between tumour molecular profile and preoperative imaging data (FDG and FDOPA PET-scan and multimodal MRI).

Cohort

Eligibility Criteria

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

The study population represents the totality of patients with a glioma surgery in the centre between February 2015 and May 2019, with a complete and usable medical file.

You may qualify if:

  • Subject 18 years of age or older, having been informed of the research
  • Subject operated on with an incident glioma of grade II or III, histologically confirmed (WHO 2016 classification)
  • Subject for which all preoperative imaging data is available (MRI, FDG and FDOPA PET-scan)
  • Subject for which molecular data of the lesion are available

You may not qualify if:

  • Subject having signified his opposition to the use of his medical data
  • Subject under safeguard of justice, guardianship or trusteeship
  • Subject with incomplete or missing part of the molecular and/or imaging data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Privé Clairval

Marseille, 13009, France

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Philippe METELLUS, MD PD

    Hôpital Privé Clairval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 8, 2020

Study Start

September 30, 2019

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations