Engineering Immune Organoids to Study Pediatric Cancer

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 25 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05890781
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Tumor, Kidney Tumor, Neuroblastoma, Sarcoma
Arms & Interventions

Arms

Other: Immune organoids from pediatric patient tissues using iPSC

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Gustave Roussy, Villejuif, France

Status

Recruiting

Address

Gustave Roussy

Villejuif, , 94805

Site Contact

Claudia PASQUALINI

[email protected]

+33 (0)1 42 11 55 31

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