Brain TumorIMMUNEORGANOIDNCT05890781
Engineering Immune Organoids to Study Pediatric Cancer
A study testing Skin biopsy, Fresh tumor sample and Blood sample in people with Brain Tumor and Kidney Tumor, run by Gustave Roussy, Cancer Campus, Grand Paris at 2 sites in France.
Trial summary
To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC) Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Brain Tumor, Kidney Tumor, Neuroblastoma
- What is being tested?
- Skin biopsy, Fresh tumor sample and Blood sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesFrance
- Study dates
- 12 May 2023to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hopital Necker
Paris, Île-de-France Region, 75015
Kevin BECCARIA, +33 1 71 19 63 40, kevin.beccaria@aphp.fr
- Recruiting
Gustave Roussy
Villejuif, 94805
Claudia PASQUALINI, +33 (0)1 42 11 55 31, claudia.pasqualini@gustaveroussy.fr
About this study
Official title: Engineering Immune Organoids to Study Pediatric Cancer (IMMUNE-ORGANOIDS)
To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC)
- Conditions
- Brain Tumor, Kidney Tumor, Neuroblastoma, Sarcoma
- Being tested
- Skin biopsy, Fresh tumor sample, Blood sample, Healthy tissue from the tumor, Spinal cerebrospinal fluid (SCF)
- Medical subject headings
- Brain Neoplasms, Carcinoma, Renal Cell, Neuroblastoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsyProcedure or surgery
Skin biopsy
Fresh tumor sampleProcedure or surgery
Fresh tumor sample
Blood sampleBiological
Blood sample in heparin tubes (highly recommended), to be collected before starting treatment or as soon as hematological recovery has been reached
Healthy tissue from the tumorProcedure or surgery
Healthy tissue from the tumor site whenever possible
Spinal cerebrospinal fluid (SCF)Procedure or surgery
Spinal cerebrospinal fluid (SCF) whenever possible
| Study group | Role | What they receive |
|---|---|---|
| Immune organoids from pediatric patient tissues using iPSC | Other | To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC) Receives: Procedure: Skin biopsy; Procedure: Fresh tumor sample; Biological: Blood sample; Procedure: Healthy tissue from the tumor; Procedure: Spinal cerebrospinal fluid (SCF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of viable and exploitable immune organoids with engrafted tumor cells
Measured: until 5 years after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start12 May 2023
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890781
- Sponsor's protocol ID
- 2020-A03021-38
- Other IDs
- 2020/3712
- Acronym
- IMMUNEORGANOID
- Status last verified
- Feb 2026
- First submitted
- 26 May 2023
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engineering Immune Organoids to Study Pediatric Cancer (IMMUNE-ORGANOIDS)
- ClinicalTrials.gov ID
- NCT05890781
- Acronym / sponsor ID
- IMMUNEORGANOID / 2020-A03021-38
- Conditions
- Brain Tumor, Kidney Tumor, Neuroblastoma, Sarcoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immune organoids from pediatric patient tissues using iPSC | Other | Procedure: Skin biopsy, Procedure: Fresh tumor sample, Biological: Blood sample, Procedure: Healthy tissue from the tumor, Procedure: Spinal cerebrospinal fluid (SCF)To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC) |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin biopsySkin biopsy | Procedure or surgery | Immune organoids from pediatric patient tissues using iPSC |
| Fresh tumor sampleFresh tumor sample | Procedure or surgery | Immune organoids from pediatric patient tissues using iPSC |
| Blood sampleBlood sample in heparin tubes (highly recommended), to be collected before starting treatment or as soon as hematological recovery has been reached | Biological | Immune organoids from pediatric patient tissues using iPSC |
| Healthy tissue from the tumorHealthy tissue from the tumor site whenever possible | Procedure or surgery | Immune organoids from pediatric patient tissues using iPSC |
| Spinal cerebrospinal fluid (SCF)Spinal cerebrospinal fluid (SCF) whenever possible | Procedure or surgery | Immune organoids from pediatric patient tissues using iPSC |
Primary outcome
Proportion of viable and exploitable immune organoids with engrafted tumor cells
Time frame: until 5 years after enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin biopsy, Fresh tumor sample and Blood sample in people with Brain Tumor and Kidney Tumor, run by Gustave Roussy, Cancer Campus, Grand Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia PASQUALINI, MD (+33 (0)1 42 11 55 31, claudia.pasqualini@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of viable and exploitable immune organoids with engrafted tumor cells (time frame: until 5 years after enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.