NCT05890781

Brief Summary

To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
May 2023May 2028

Study Start

First participant enrolled

May 12, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

May 26, 2023

Last Update Submit

February 5, 2026

Conditions

Brain TumorKidney TumorNeuroblastomaSarcoma

Outcome Measures

Primary Outcomes (1)

  • Proportion of viable and exploitable immune organoids with engrafted tumor cells

    until 5 years after enrolment

Study Arms (1)

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 biopsyProcedure: Fresh tumor sampleBiological: Blood sampleProcedure: Healthy tissue from the tumorProcedure: Spinal cerebrospinal fluid (SCF)

Interventions

Skin biopsyPROCEDURE

Skin biopsy

Immune organoids from pediatric patient tissues using iPSC
Blood sampleBIOLOGICAL

Blood sample in heparin tubes (highly recommended), to be collected before starting treatment or as soon as hematological recovery has been reached

Immune organoids from pediatric patient tissues using iPSC
Spinal cerebrospinal fluid (SCF)PROCEDURE

Spinal cerebrospinal fluid (SCF) whenever possible

Immune organoids from pediatric patient tissues using iPSC
Fresh tumor samplePROCEDURE

Fresh tumor sample

Immune organoids from pediatric patient tissues using iPSC
Healthy tissue from the tumorPROCEDURE

Healthy tissue from the tumor site whenever possible

Immune organoids from pediatric patient tissues using iPSC

Eligibility Criteria

AgeUp to 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Adult patient or parents/guardians incapable/incapable of giving its/their consent
  • Patients deprived of their liberty by a judicial or administrative decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gustave Roussy

Villejuif, 94805, France

RECRUITING

Hopital Necker

Paris, Île-de-France Region, 75015, France

RECRUITING

MeSH Terms

Conditions

Brain NeoplasmsCarcinoma, Renal CellNeuroblastomaSarcoma

Interventions

Blood Specimen CollectionCerebrospinal Fluid Pressure

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNeoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Claudia PASQUALINI, MD

CONTACT

+33 (0)1 42 11 55 31claudia.pasqualini@gustaveroussy.fr

Jérémy MIONE, MS

CONTACT

+33 (0)1 42 11 42 11jeremy.mione@gustaveroussy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 6, 2023

Study Start

May 12, 2023

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

FR(2)