Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000597695
Ethics application status
Approved
Date submitted
24/04/2023
Date registered
31/05/2023
Date last updated
27/10/2023
Date data sharing statement initially provided
31/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Paediatric Immune Cell Atlas: establishing an atlas of the immune system of children aged 0-18 years old.
Scientific title
Paediatric Immune Cell Atlas
Secondary ID [1] 309422 0
None
Universal Trial Number (UTN)
Trial acronym
PICA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune Diseases 329798 0
Condition category
Condition code
Inflammatory and Immune System 326693 326693 0 0
Normal development and function of the immune system
Inflammatory and Immune System 326694 326694 0 0
Autoimmune diseases
Inflammatory and Immune System 326695 326695 0 0
Other inflammatory or immune system disorders
Inflammatory and Immune System 326696 326696 0 0
Allergies

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study aiming to characterise the immune system of healthy children and children with immune diseases. There are three cohorts in this study, and each cohort has different biospecimen collection requirements:

- Healthy cohort: defined as children without any immune related diseases, such as autoimmune diseases, allergies diagnosed by a health professional, etc. Participants consenting to the Healthy cohort may choose to consent to the longitudinal arm, which will allow for serial blood collections.

- Cardiac Surgery cohort: participants who meet all criteria for the healthy cohort and are also undergoing open heart surgery, which will allow for thymus tissue collection. Thymus tissue is routinely discarded during open heart surgery.

-Immune Disease cohort: participants who are formally diagnosed with a immune disease, such as known Primary Immunodeficiencies or autoimmune diseases, including but not limited to lupus, rheumatoid arthritis, seronegative arthritis, type 1 diabetes, autoimmune thyroid disease, and vasculitis. Subjects with allergies diagnosed by an appropriately qualified medical practitioner can be included in this cohort.

All participants will be requested to provide a blood sample. Ideally, 4- 12 mL of peripheral blood must be collected in EDTA tubes. For very young and/or low weight participants the minimum acceptable amount of blood for collection is 0.5 mL. Participants in the Healthy cohort who are consented for longitudinal collection will be requested to provide a blood sample every 6 months for a period of two years.
Intervention code [1] 325946 0
Not applicable
Comparator / control treatment
Healthy cohort: comprised of children without any conditions related to the immune system. For a more detailed definition, please refer to the eligibility criteria.
Control group
Active

Outcomes
Primary outcome [1] 334559 0
Characterisation of immune cell populations in children by performing single-cell RNA sequencing in blood samples from participants enrolled in three cohorts: 1) Healthy cohort, 2) Immune disease cohort and 3) Heart Surgery cohort.
Timepoint [1] 334559 0
To be achieved by the end of the study. The study is expected to last 3 years.

There will be a single blood collection timepoint for all participants, except for a subset of participants in the healthy cohort who might choose to consent to optional longitudinal blood collections every 6 months for a period of 2 years.
Secondary outcome [1] 421183 0
nil
Timepoint [1] 421183 0
nil

Eligibility
Key inclusion criteria
Inclusion Criteria for Healthy Cohort
• Children aged less than 18 years old.

Inclusion criteria for Cardiac Surgery Cohort
• Undergoing open cardiac surgery with sternotomy approach will be eligible for the Cardiac Surgery Cohort.
• Meeting the same inclusion criteria as the Healthy Cohort.

Inclusion Criteria for Immune Disease Cohort
Children aged less than 18 years old who are diagnosed with immunological disease.
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria for Healthy Cohort
• Subjects with known immunological disease.
• Use of significant immune-modulating drug treatment.
• Subjects with allergic symptoms within the last two months and/or subjects with allergies diagnosed by a qualified medical practitioner.
• First degree relative (parent or sibling) with confirmed systemic autoimmune disease or primary immune deficiency.
• Subjects who have been organ transplant recipients or donors.
• Cancer or a history of cancer that is currently in remission.
• Type 2 diabetes.
• Known pregnancy.
• Known infection with HIV or Hepatitis C.
• Subjects who had a respiratory infection within the last two weeks, e.g., RSV, Influenza, SARS-CoV2, and/or flu-like symptoms for which no known causal agent could be determined.
• Subjects with insufficient or inadequate biospecimens available for analysis.
Children diagnosed with other conditions, not described above, will be considered eligible for the healthy cohort. Children with suspected allergies who haven’t shown any allergic symptoms in the last 2 months can be included in the healthy cohort.

Exclusion criteria for Cardiac Surgery Cohort
• Subjects with known immunological disease.
• Use of significant immune-modulating drug treatment.
• Subjects with allergic symptoms within the last two months and/or subjects with allergies diagnosed by a qualified medical practitioner.
• First degree relative (parent or sibling) with confirmed systemic autoimmune disease or primary immune deficiency.
• Subjects who have been organ transplant recipients or donors.
• Cancer or a history of cancer that is currently in remission.
• Type 2 diabetes.
• Known pregnancy.
• Known infection with HIV or Hepatitis C.
• Subjects who had a respiratory infection within the last two weeks, e.g., RSV, Influenza, SARS-CoV2, and/or flu-like symptoms for which no known causal agent could be determined.
• Subjects with insufficient or inadequate biospecimens available for analysis.
Children diagnosed with other conditions, not described above, will be considered eligible for this cohort. Children with suspected allergies who haven’t shown any allergic symptoms in the last 2 months can be included in this cohort.

Exclusion Criteria for Immune Disease Cohort
• Subjects who have been organ transplant recipients or donors.
• Cancer or a history of cancer that is currently in remission.
• Type 2 diabetes.
• Known pregnancy.
• Known infection with HIV or Hepatitis C.
• Subjects who had a respiratory infection within the last two weeks, e.g., RSV, Influenza, SARS-CoV2, and/or flu-like symptoms for which no known causal agent could be determined.
• Subjects with insufficient or inadequate biospecimens available for analysis.

Study design
Purpose
Duration
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
This is a prospective study with both a cross-sectional and a longitudinal component as described in the definition of the cohorts. To build a comprehensive reference atlas that accurately represents the healthy paediatric immune system, our goal is to recruit as many participants as possible. However, due to limitations in resources and costs, we have decided to cap our sample size at approximately 1000-1600 individuals over 3 years. This will allow us to collect and analyse a large enough sample size to generate a representative reference while being mindful of practical constraints. We will also ensure that our sample is diverse and representative of different age groups, genders, and ethnicities to ensure the atlas is comprehensive and applicable to a wide range of paediatric patients.

To compare cells across different patient samples - extracted at different timepoints – a series of data processing exercises are needed to generate meaningful results. Furthermore, given the complexity of scRNA-seq datasets, which can span over 20,000 parameters in ~50,000 cells, dimensionality reduction techniques must be employed to visualise such high-dimensional data. This step is necessary because not all genes are essential to classify cells into meaningful clusters, and thus dimensionality reduction techniques allow us to condense data complexity and to visualise the data. To accomplish this our bioinformatics team will handle these aspects, from data cleaning to data analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/11/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24596 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 40193 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 313617 0
Charities/Societies/Foundations
Name [1] 313617 0
Children's Hospital Foundation
Country [1] 313617 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Children's Hospital Foundation
Address
Level 14/199 Grey St, South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 315409 0
Other
Name [1] 315409 0
Ian Frazer Centre for Children's Immunotherapy Research
Address [1] 315409 0
Level 4 CCHR, 62 Graham St, South Brisbane, QLD, 4101
Country [1] 315409 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312790 0
Children’s Health Queensland Human Research Ethics Committee
Ethics committee address [1] 312790 0
Ethics committee country [1] 312790 0
Australia
Date submitted for ethics approval [1] 312790 0
17/04/2023
Approval date [1] 312790 0
30/10/2023
Ethics approval number [1] 312790 0
HREC/23/QCHQ/96967

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125930 0
Dr Wayne Nicholls
Address 125930 0
Queensland Children's Hospital
Level 6, 62 Graham Street
South Brisbane QLD 4101
Country 125930 0
Australia
Phone 125930 0
+61 7 3068 5416
Fax 125930 0
Email 125930 0
[email protected]
Contact person for public queries
Name 125931 0
Emely Hernandez
Address 125931 0
Queensland Children's Hospital
Level 6, 62 Graham Street
South Brisbane QLD 4101
Country 125931 0
Australia
Phone 125931 0
+61 7 30681749
Fax 125931 0
Email 125931 0
[email protected]
Contact person for scientific queries
Name 125932 0
Di Yu
Address 125932 0
Ian Frazer Centre for Children's Immunotherapy Research
Level 4, 62 Graham Street
South Brisbane QLD 4101
Country 125932 0
Australia
Phone 125932 0
+61 07 3443 6954
Fax 125932 0
Email 125932 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19318Study protocol  [email protected] Study protocol will be available after all approva... [More Details]



Results publications and other study-related documents

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