Grafts of GSCs Into Brain Organoids for Testing Anti-inva... | NCT05772741

Studies
Grafts of GSCs Into Brain Organoids for Testing Anti-invasion Drugs

NCT05772741

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Unknown status

Last Update Posted

Mar 16, 2023Actual

Enrollment

160Estimated

Phase

Not Applicable

Conditions

Glioblastoma
Glioma, Malignant

Interventions

Biological sample collection

Countries

Italy

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 2023

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

Dec 3, 2018Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Feb 23, 2023

First Submission Date that Met QC Criteria

Mar 6, 2023

First Posted Date

Mar 16, 2023Actual

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

Mar 6, 2023

Last Update Posted Date

Mar 16, 2023Actual

Name	Class
Catholic University of the Sacred Heart	OTHER
Istituto Superiore di Sanità	OTHER
Heinrich-Heine University, Duesseldorf	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

In patients operated for glioblastoma, glioma stem-like cell lines will be obtained from tumor tissue, and IPSCs from skin fibroblasts or PBMCs. Brain organoids will be generated from IPSCs and co-cultured with IPSCs to study brain invasion and ciliogenesis. 3D genome architecture of glioma stem-like cells will be investigated. Gene modulation and pharmacologic strategies to inhibit invasion and restore ciliogenesis will be explored.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biological sample collection	Other	Tumor tissue for glioma stem-like cell culture generation. Skin or PBMC for organoid generation	Other: Biological sample collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biological sample collection	Other	Collection of biological samples	Biological sample collection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Invasion	Distance travelled by glioma stem cells into brain organoids	through study completion, an average of 4 years
Gene assessment	Identification of genes responsible of GSC invasion, among those reportedly involved in self-renewal and ciliogenesis	through study completion, an average of 4 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

o be enrolled in the study patients must:

Have a radiological diagnosis of supratentorial glioblastoma, or
Have a radiological diagnosis of first recurrence of a primary supratentorial glioblastoma (for which a formal histopathologic diagnosis of glioblastoma had made at first surgery), according with RANO criteria (Wen, 2010);
Be a candidate to neurosurgery for glioblastoma;
Be of an age of 18 years or above;
Provide written informed consent for participation to the study.

Exclusion criteria

To be enrolled in the study patients must not:

Have not enough pathological material removed at surgery available both for mandatory routine histopathological diagnosis and for the present study, as judged by the Principal Investigator;
Have not a definitive pathological diagnosis of a primary supratentorial glioblastoma, according with 2016 WHO classification.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Roberto Pallini, MD, PhD	Contact	+39 06 3015 5414		roberto.pallini@unicatt.it
Lucia Ricci-Vitiani, PhD	Contact	+39 06 49901		lucia.riccivitiani@iss.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Universitario A. Gemelli IRCCS	Recruiting	Rome		00168	Italy

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
D005909	Glioblastoma
D005910	Glioma

Ancestor Terms

ID	Term
D001254	Astrocytoma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal

Browse Leaves

Not provided

Browse Branches

Not provided