Engineering Immune Organoids to Study Pediatric Cancer | NCT05890781

Studies
Engineering Immune Organoids to Study Pediatric Cancer

NCT05890781

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Recruiting

Last Update Posted

Feb 9, 2026Actual

Enrollment

108Estimated

Phase

Not Applicable

Conditions

Brain Tumor
Kidney Tumor
Neuroblastoma
Sarcoma

Interventions

Skin biopsy
Fresh tumor sample
Blood sample
Healthy tissue from the tumor
Spinal cerebrospinal fluid (SCF)

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

ID	Type	Description	Link
2020/3712	Other Identifier	CSET number

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 12, 2023Actual

Primary Completion Date

May 2028Estimated

Completion Date

May 2028Estimated

First Submitted Date

May 26, 2023

First Submission Date that Met QC Criteria

May 26, 2023

First Posted Date

Jun 6, 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

Feb 5, 2026

Last Update Posted Date

Feb 9, 2026Actual

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

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

108Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immune organoids from pediatric patient tissues using iPSC	Other	To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC)	Procedure: Skin biopsy Procedure: Fresh tumor sample Biological: Blood sample Procedure: Healthy tissue from the tumor Procedure: Spinal cerebrospinal fluid (SCF)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Skin biopsy	Procedure	Skin biopsy	Immune organoids from pediatric patient tissues using iPSC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of viable and exploitable immune organoids with engrafted tumor cells		until 5 years after enrolment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age at diagnosis ≤ 25 years except for patients with malignant gliomas and renal tumors for whom no upper age limit is applied
Medical suspicion or diagnosis of one of the following diseases, regardless of stage:
Brain tumors
Renal tumors
Neuroblastoma
Sarcomas
Adult patient or parents or guardians should understand, sign and date the appropriate written informed consent from prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
Affiliated to a social security system or beneficiary of the same.

Exclusion Criteria:

Any histology not mentioned in the inclusion criteria
Adult patient or parents/guardians incapable/incapable of giving its/their consent
Patients deprived of their liberty by a judicial or administrative decision

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Claudia PASQUALINI, MD	Contact	+33 (0)1 42 11 55 31		claudia.pasqualini@gustaveroussy.fr
Jérémy MIONE, MS	Contact	+33 (0)1 42 11 42 11	38 61	jeremy.mione@gustaveroussy.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gustave Roussy	Recruiting	Villejuif		94805	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms
D002292	Carcinoma, Renal Cell
D009447	Neuroblastoma
D012509	Sarcoma

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection
D015170	Cerebrospinal Fluid Pressure

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided