Engineering Immune Organoids to Study Pediatric Cancer (IMMUNEORGANOID)

February 5, 2026 updated by: Gustave Roussy, Cancer Campus, Grand Paris

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75015
        • Recruiting
        • Hôpital Necker
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: until 5 years after enrolment
until 5 years after enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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