Molecular Characterization of Gliomas Using a Broad Next... | NCT05486247

Studies
Molecular Characterization of Gliomas Using a Broad Next Generation Sequencing (NGS)Panel

NCT05486247

Sponsor

Hellenic Cooperative Oncology Group

Status

Completed

Last Update Posted

Aug 3, 2022Actual

Enrollment

32Actual

Phase

Not provided

Conditions

Malignant Glioma

Interventions

Not provided

Countries

Not provided

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

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 4, 2015Actual

Primary Completion Date

Dec 1, 2021Actual

Completion Date

May 1, 2022Actual

First Submitted Date

Aug 2, 2022

First Submission Date that Met QC Criteria

Aug 2, 2022

First Posted Date

Aug 3, 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

Aug 2, 2022

Last Update Posted Date

Aug 3, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rania Romanidou, Dr Ourania Romanidou, Hellenic Cooperative Oncology GroupPrincipal Investigator

Lead Sponsor

Hellenic Cooperative Oncology GroupOTHER

Collaborators

Not provided

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

Gliomas are the most common malignant primary brain tumors with poor prognosis. The genotyping of tumors using NGS platforms enables the identification of genetic alterations that constitute diagnostic, prognostic and predictive biomarkers.Here in, we investigated the molecular profile of 32 tumor samples from 32 patients with high grade gliomas by implementing a broad 80-gene targeted NGS panel while reporting their clinicopathological characteristics and outcomes.

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

32Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The prevalence of genetic alterations in patients with high grade glioma using a 80 gene NGS panel	The prevalence of genetic alterations in patients with high grade glioma using a 80 gene NGS panel	April 2019 - December 2021

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of high grade glioma based on tissue biopsy

Exclusion Criteria:

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 with diagnosis of high grade glioma treated in 2 centers of the Hellenic Cooperative Oncology Group (HeCOG).

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D005910	Glioma

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided