Engineering Immune Organoids to Study Pediatric Cancer

Not Applicable

Recruiting

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

• Registration Number: NCT05890781
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05-12
• Study First Submitted: 2023-05-26
• Study First Submitted QC: 2023-05-26
• Last Update Submitted: 2023-05-26
• Study First Posted: 2023-06-06
• Last Update Posted: 2023-06-06
• Primary Completion: 2028-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immune organoids from pediatric patient tissues using iPSC	Fresh tumor sample	To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC)
Immune organoids from pediatric patient tissues using iPSC	Skin biopsy	To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC)
Immune organoids from pediatric patient tissues using iPSC	Blood sample	To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC)
Immune organoids from pediatric patient tissues using iPSC	Healthy tissue from the tumor	To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC)
Immune organoids from pediatric patient tissues using iPSC	Spinal cerebrospinal fluid (SCF)	To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC)

Primary Outcome Measures

Name	Time	Method
Proportion of viable and exploitable immune organoids with engrafted tumor cells	until 5 years after enrolment

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, France