IMMUNEORGANOID: Engineering Immune Organoids to Study Pediatric Cancer

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05890781
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 59.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor; Kidney Tumor; Neuroblastoma; Sarcoma	Procedure: Skin biopsy; Procedure: Fresh tumor sample; Biological: Blood sample; Procedure: Healthy tissue from the tumor; Procedure: Spinal cerebrospinal fluid (SCF)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 44 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Engineering Immune Organoids to Study Pediatric Cancer (IMMUNE-ORGANOIDS)
• Actual Study Start Date: May 12, 2023
• Anticipated Primary Completion Date: May 1, 2028
• Anticipated Study Completion Date: May 1, 2028

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of viable and exploitable immune organoids with engrafted tumor cells [until 5 years after enrolment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gustave Roussy	Villejuif		France	94805

Sponsors and Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
• ClinicalTrials.gov Identifier: NCT05890781
• Other Study ID Numbers: 2020-A03021-38; 2020/3712
• First Posted: Jun 6, 2023
• Last Update Posted: Jun 6, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neuroblastoma; Kidney Neoplasms

Study Results

No Results Posted as of Jun 6, 2023