Identification by Transcriptomic Approach of New Prognost... | NCT05259332

Studies
Identification by Transcriptomic Approach of New Prognostic and Predictive Markers in a Cohort of Atypical Meningiomas

NCT05259332

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Feb 28, 2022Actual

Enrollment

85Estimated

Phase

Not provided

Conditions

Meningioma Atypical

Interventions

Not provided

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

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 25, 2022Estimated

Primary Completion Date

Apr 1, 2022Estimated

Completion Date

Oct 31, 2023Estimated

First Submitted Date

Feb 8, 2022

First Submission Date that Met QC Criteria

Feb 18, 2022

First Posted Date

Feb 28, 2022Actual

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

Feb 18, 2022

Last Update Posted Date

Feb 28, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Guillaume GAUCHOTTE, University professor and Hospital practitioner, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Determine by a transcriptomic approach new prognostic and predictive markers in atypical meningiomas (WHO grade II).

Retrospective observational study, on a cohort of 85 atypical meningiomas. Transcriptomic study first, on cryopreserved tumor samples. Then identify, thanks to the transcriptomic study, prognostic and predictive factors (study of the link between the quantity of certain RNA transcripts and progression-free survival). Finally, set up immunohistochemical applications, which can be used routinely by the pathologist.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

85Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival	Progression being defined by a growth (mm3) of the tumor objectified by imaging.	through study completion an average of 5 years.

Secondary Outcomes

Measure	Description	Time Frame
Tumor volume assessed by imaging pre- and post-operative	mm3; RECIST criteria	before and within 3 months after surgery
mRNA quantities of transcripts of interest	µg.mL-1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary operated patients for an atypical meningioma (WHO grade II) in the Neurosurgery department of the University Hospital of Nancy.
At least one postoperative follow-up visit.
Adult patients (>18 yo) at the time of the intervention.
Surgical excision.

Exclusion Criteria:

History of meningioma in the same location.
Neo-adjuvant treatment.
Absence of non-objection form.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients included in the collection of biological samples from the Department of Pathological Anatomy and Cytology and the Biological Resource Center (CHRU Nancy).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guillaume GAUCHOTTE, PUPH	Contact	+33 3 83 65 60 17		g.gauchotte@univ-lorraine.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guillaume GAUCHOTTE	Recruiting	Vandœuvre-lès-Nancy	Lorraine	54511	France