Engineering Immune Organoids to Study Pediatric Cancer (IMMUNEORGANOID)

Engineering Immune Organoids to Study Pediatric Cancer (IMMUNE-ORGANOIDS)

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

Study Overview

• Status: Recruiting
• Conditions: Sarcoma; Brain Tumor; Neuroblastoma; Kidney Tumor
• Intervention / Treatment: Procedure: Skin biopsy; Procedure: Fresh tumor sample; Biological: Blood sample; Procedure: Healthy tissue from the tumor; Procedure: Spinal cerebrospinal fluid (SCF)

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jérémy MIONE, MS; Phone Number: 38 61 +33 (0)1 42 11 42 11; Email: jeremy.mione@gustaveroussy.fr
• Study Contact Backup: Name: Claudia PASQUALINI, MD; Phone Number: +33 (0)1 42 11 55 31; Email: claudia.pasqualini@gustaveroussy.fr

Study Locations

• France
  • Villejuif, France, 94805
    • Recruiting
    • Gustave Roussy
    • Contact: Claudia PASQUALINI; Phone Number: +33 (0)1 42 11 55 31; Email: claudia.pasqualini@gustaveroussy.fr
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75015
      • Recruiting
      • Hopital Necker
      • Contact: Kevin BECCARIA; Phone Number: +33 1 71 19 63 40; Email: kevin.beccaria@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Procedure: Skin biopsy; Skin biopsy; Procedure: Fresh tumor sample; Fresh tumor sample; Biological: Blood sample; Blood sample in heparin tubes (highly recommended), to be collected before starting treatment or as soon as hematological recovery has been reached; Procedure: Healthy tissue from the tumor; Healthy tissue from the tumor site whenever possible; Procedure: Spinal cerebrospinal fluid (SCF); Spinal cerebrospinal fluid (SCF) whenever possible

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): June 6, 2023

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Kidney Neoplasms; Neoplasms, Connective and Soft Tissue; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Central Nervous System Neoplasms; Carcinoma, Renal Cell; Neuroblastoma; Sarcoma; Brain Neoplasms; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Nervous System Physiological Phenomena; Blood Specimen Collection; Cerebrospinal Fluid Pressure
• Other Study ID Numbers: 2020-A03021-38; 2020/3712 (Other Identifier: CSET number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No