Glioma Brain Tumours - E12513 - SensiScreen Glioma | NCT04539431

Studies
Glioma Brain Tumours - E12513 - SensiScreen Glioma

NCT04539431

Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Status

Unknown status

Last Update Posted

Jan 24, 2022Actual

Enrollment

220Estimated

Phase

Not provided

Conditions

Glioma

Interventions

validation of new technologies

Countries

Switzerland

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

Jan 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

Jan 7, 2022Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Aug 31, 2020

First Submission Date that Met QC Criteria

Aug 31, 2020

First Posted Date

Sep 7, 2020Actual

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

Jan 7, 2022

Last Update Posted Date

Jan 24, 2022Actual

Name	Class
Istituto Cantonale di Patologia	OTHER
Neurocenter of Southern Switzerland	OTHER

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

Validation of a new platform for the molecular characterization of patients affected by glioma. The new platform includes a series of faster, less expensive real-time PCR methodologies that, in comparison to standard analyses (DS, MS-PCR), are also characterized by higher sensitivity and consequently can be able to identify mutations in ctDNA extracted from liquid biopsies as well. The development of these assays will allow the analysis of molecular markers alteration even in liquid biopsies, providing a less invasive sampling than tissue biopsies, a procedure that sometimes is characterized by side effects or that allow the collection of few tissues for the histological and molecular diagnosis.

This study will not interfere with the patients routine treatment pathway and there will be no deviation from the standard of care: the molecular characterization of the tissues will be performed according to the standard diagnostic routine using the currently approved methodologies. For the retrospective study, it will be used the left-over DNA. For the cohort, that includes the collection and the subsequent analysis of liquid biopsies (prospective study), blood and CSF will be sampled during surgery.

The mutations in the molecular markers will be analyzed in tissue as well as in plasma and CFS samples by the new real-time based assays. Then, the qualitative and quantitative values obtained on liquid biopsies with the new methodology will be compared to the results of the standard methodologies already obtained, for diagnostic routine, on surgical tissue samples of the same patients.

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

220Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Retrospective		The cases with glioma will be identified in the databases of hospital, the material will be preliminarily evaluated in order to see if there is sufficient tissue left for analysis.	Genetic: validation of new technologies
Prospective		A blood sample for molecular analyses will be collected in all the cases, CSF samples will be taken only if recommended by the normal surgical routine.	Genetic: validation of new technologies

Interventions

Name	Type	Description	Arm Group Labels	Other Names
validation of new technologies	Genetic	Development of a new molecular assay on tissue as well as on liquid biopsies (plasma and CSF), based on a single, open, real-time PCR platform with unprecedented sensitivity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Demonstration that the new methodology improves the features	Demostrate that are found at least the same number of mutations in comparison with respect to standard tests	2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Retrospective Cohort

Inclusion Criteria:

Patient with available tissue material or with available molecular data concerning the tissue biopsy obtained during surgery and analyzed for diagnosis

Exclusion Criteria:

Insufficient amount of tumor cells in the tissue biopsy for the molecular characterization
Inability to consent and follow the procedures of the study (for alive patients)

Prospective Cohort

Inclusion Criteria:

Age ≥ 18 years old
Affected by suspected glioma and requiring surgery
Patient with available tissue material or with available molecular data concerning the tissue biopsy obtained during surgery and analyzed for diagnosis
Written informed consent

Exclusion Criteria:

Insufficient amount of tumor cells in the tissue biopsy for the molecular characterization
Inability to consent and follow the procedures of the study
Women who are pregnant or breast feeding

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 affected by suspected glioma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Milo Frattini, PhD	Contact	+ 41 (0)91 816 08 05		milo.frattini@eoc.ch

Overall Officials

Name	Affiliation	Role
Milo Frattini, PhD	Institute of Pathology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Pathology Ente Ospedaliero Cantonale	Recruiting	Locarno		6600	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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

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Browse Branches

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