Kidney TransplantNCT07532382
Personalized Stories for Pediatric Kidney Recipients
An observational study of Kidney Transplant, run by Paris Translational Research Center for Organ Transplantation at 1 site in France.
Trial summary
Pediatric kidney transplant recipients often face major psychosocial challenges that are difficult to address with existing tools. This study evaluates whether clinically supervised AI can generate personalized, age-adapted therapeutic stories for these children and their families. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- AI-generated story and AI generated story
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric kidney recipients
Who may be able to join
- Age 5-12 years inclusive at enrolment.
- Recipient of a kidney transplant.
- Clinically stable at enrolment (no active rejection, acute infection, or current hospitalization for a graft-related complication).
- Fluency in French or English.
- Written informed consent from parent(s)/legal guardian(s); child assent when age-appropriate.
Who cannot join
- Severe cognitive impairment precluding engagement with narrative content.
- Mental state not allowing participation.
- Family unwilling or unable to commit to the study timeline and interview requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Necker hospital
Paris, Île-de-France Region, 75015
Evgenia Preka, MD, PhD, +33144494000, evgenia.preka@aphp.fr
About this study
Official title: Generating Personalized Stories With Artificial Intelligence for Pediatric Kidney Recipients
Pediatric kidney transplant recipients often face major psychosocial challenges that are difficult to address with existing tools. This study evaluates whether clinically supervised AI can generate personalized, age-adapted therapeutic stories for these children and their families.
Read the detailed description
Pediatric kidney transplant recipients face substantial psychosocial challenges, including anxiety, fear, difficulty understanding complex medical experiences, and challenges returning to school and social life. Therapeutic storytelling may help children process these experiences, but truly personalized stories are difficult to produce manually at scale. Large language models offer the opportunity to generate age-adapted, personalized, and clinically supervised stories. This study aims to develop and evaluate an AI-assisted storytelling workflow for pediatric kidney recipients and their families.
- Conditions
- Kidney Transplant
- Being tested
- AI-generated story, AI generated story
- Keywords
- Artificial intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-generated storyOther
A story generated by artificial intelligence is created and personalized for pediatric kidney recipient
AI generated storyOther
This is a minimal-risk observational study. Families complete a questionnaire and receive an AI-generated, clinically supervised personalized story. During the pilot phase, there is no direct child-AI interaction. All stories are reviewed by the clinical lead before delivery.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric kidney recipient | Not described Receives: Other: AI-generated story; Other: AI generated story |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child and family experience of the story after delivery.
Child and family experience of the story, assessed through qualitative feedback, thematic analysis, and satisfaction ratings collected after story delivery.
Measured: One month after story delivery
Child and family experience of the story after delivery.
Child and family experience of the story, assessed through qualitative feedback, thematic analysis, and satisfaction ratings collected after story delivery.
Measured: One month after the story is delivered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Mar 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paris Translational Research Center for Organ Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Raynaud, Paris Translational Research Center for Organ Transplantation
- Investigators
- Marc Raynaud, PhD, Principal investigator, Paris Institute for Transplantation and Organ RegenerationEvgenia Preka, MD, PhD, Principal investigator, Paris Institute for Transplantation and Organ Regeneration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532382
- Sponsor's protocol ID
- LLM_Kids
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: These will be data related to pediatric kidney recipients.
Publications
Lorenzini G, Arbelaez Ossa L, Milford S, Elger BS, Shaw DM, De Clercq E. The "Magical Theory" of AI in Medicine: Thematic Narrative Analysis. JMIR AI. 2024 Aug 19;3:e49795. doi: 10.2196/49795.
PubMed 39158953
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generating Personalized Stories With Artificial Intelligence for Pediatric Kidney Recipients
- ClinicalTrials.gov ID
- NCT07532382
- Acronym / sponsor ID
- LLM_Kids
- Conditions
- Kidney Transplant
- Keywords
- Artificial intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Paris Translational Research Center for Organ TransplantationUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pediatric kidney transplant recipients often face major psychosocial challenges that are difficult to address with existing tools. This study evaluates whether clinically supervised AI can generate personalized, age-adapted therapeutic stories for these children and their families.
Detailed description
Pediatric kidney transplant recipients face substantial psychosocial challenges, including anxiety, fear, difficulty understanding complex medical experiences, and challenges returning to school and social life. Therapeutic storytelling may help children process these experiences, but truly personalized stories are difficult to produce manually at scale. Large language models offer the opportunity to generate age-adapted, personalized, and clinically supervised stories. This study aims to develop and evaluate an AI-assisted storytelling workflow for pediatric kidney recipients and their families.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric kidney recipient | – | Other: AI-generated story, Other: AI generated story |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric kidney recipients
Key inclusion criteria (5 listed)
- Age 5-12 years inclusive at enrolment.
- Recipient of a kidney transplant.
- Clinically stable at enrolment (no active rejection, acute infection, or current hospitalization for a graft-related complication).
- Fluency in French or English.
- Written informed consent from parent(s)/legal guardian(s); child assent when age-appropriate.
Key exclusion criteria (3 listed)
- Severe cognitive impairment precluding engagement with narrative content.
- Mental state not allowing participation.
- Family unwilling or unable to commit to the study timeline and interview requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-generated storyA story generated by artificial intelligence is created and personalized for pediatric kidney recipient | Other | Pediatric kidney recipient |
| AI generated storyThis is a minimal-risk observational study. Families complete a questionnaire and receive an AI-generated, clinically supervised personalized story. During the pilot phase, there is no direct child-AI interaction. All stories are reviewed by the clinical lead before delivery. | Other | Pediatric kidney recipient |
Primary outcome
Child and family experience of the story after delivery.
Time frame: One month after story delivery
Child and family experience of the story, assessed through qualitative feedback, thematic analysis, and satisfaction ratings collected after story delivery.
Child and family experience of the story after delivery.
Time frame: One month after the story is delivered
Child and family experience of the story, assessed through qualitative feedback, thematic analysis, and satisfaction ratings collected after story delivery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Results publication: PubMed 39158953Lorenzini G, Arbelaez Ossa L, Milford S, Elger BS, Shaw DM, De Clercq E. The "Magical Theory" of AI in Medicine: Thematic Narrative Analysis. JMIR AI. 2024 Aug 19;3:e49795. doi: 10.2196/49795.
- Individual participant dataSharing planned: No. These will be data related to pediatric kidney recipients.
Related trials for Kidney Transplant
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
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A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Raynaud, PhD principal investigator
Paris Institute for Transplantation and Organ Regeneration
Evgenia Preka, MD, PhD principal investigator
Paris Institute for Transplantation and Organ Regeneration
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant, run by Paris Translational Research Center for Organ Transplantation at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Raynaud, PhD (+33613493009, mrayna06@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child and family experience of the story after delivery. (time frame: One month after story delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07532382, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.