Clinical trial

Engineering Immune Organoids to Study Pediatric Cancer (IMMUNE-ORGANOIDS)

ID

Name

2020-A03021-38

Description

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

Trial arms

Trial start

2023-05-12

Estimated PCD

2028-05-01

Trial end

2028-05-01

Status

Recruiting

Treatment

Skin biopsy

Skin biopsy

Arms:

Immune organoids from pediatric patient tissues using iPSC

Fresh tumor sample

Fresh tumor sample

Arms:

Immune organoids from pediatric patient tissues using iPSC

Blood sample

Blood sample in heparin tubes (highly recommended), to be collected before starting treatment or as soon as hematological recovery has been reached

Arms:

Immune organoids from pediatric patient tissues using iPSC

Healthy tissue from the tumor

Healthy tissue from the tumor site whenever possible

Arms:

Immune organoids from pediatric patient tissues using iPSC

Spinal cerebrospinal fluid (SCF)

Spinal cerebrospinal fluid (SCF) whenever possible

Arms:

Immune organoids from pediatric patient tissues using iPSC

Size

44

Primary endpoint

Proportion of viable and exploitable immune organoids with engrafted tumor cells

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 44, 'type': 'ESTIMATED'}}

Updated at

2023-06-06

1 organization

1 product

4 indications

Organization

Gustave Roussy, Cancer Campus, Grand Paris

Product

Indication

Indication

Indication

Indication