Recruiting NCT05890781
Engineering Immune Organoids to Study Pediatric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Skin biopsy, Fresh tumor sample, Blood sample, Healthy tissue from the tumor.
- Who it may be relevant to
- Registry conditions: Brain Tumor, Kidney Tumor, Neuroblastoma, Sarcoma. Basic parameters: up to 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Engineering Immune Organoids to Study Pediatric Cancer (IMMUNE-ORGANOIDS)
Overview
To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC)
Interventions
- 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
Primary outcome measures
- Proportion of viable and exploitable immune organoids with engrafted tumor cells [Time frame: until 5 years after enrolment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 2 centers
- Gustave Roussy — Villejuif
- Hopital Necker — Paris
Identifiers
NCT: NCT05890781 · 2020-A03021-38 · 2020/3712