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Paediatric Immune Cell Atlas: establishing an atlas of the immune system of children aged 0-18 years old.

Paediatric Immune Cell Atlas

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12623000597695
Acronym
PICA
Enrollment
384
Registered
2023-05-31
Start date
2024-01-29
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The immune system defends us against infection by bacteria, viruses and cancer. An important part of the immune system is white blood cells, which include lymphocytes, neutrophils, macrophages, and dendritic cells. We can identify and classify different white blood cells according to molecules expressed on their surface, their size and function. We have established a substantial programme of research at the Ian Frazer Centre for Children’s Immunotherapy Research (IFCCIR), where we aim to investigate how we can harness the power of the immune system to fight paediatric diseases. To do so, we need to understand what is unique about children’s immune systems, so we can identify the best therapeutic strategies. Thanks to innovative technologies, we are now able to measure up to 20 thousand parameters in a single cell from thousands of individual cells from a single drop of blood. By analysing hundreds of healthy children across all ages, we will build a Paediatric Immune Cell Atlas. This atlas will act as a reference that will help us identify much needed immunotherapy targets for paediatric diseases, including cancer and auto-immune diseases. Who is it for? You might be eligible for this study if you are a child aged 0-18 years old. Children without immune diseases can be consented to the 'Healthy cohort', children with Immune diseases can be consented to the 'Immune disease cohort'. A subset of children who are considered healthy from the immunological point of view, but who are scheduled to have open heart surgery can be consented to the 'Cardiac Surgery cohort'. Additionally, children consented to the 'Healthy cohort' might opt to consent for serial blood collections every 6 months for a period of 2 years. Study details All participants will be requested to provide 1 to 2 teaspoons of blood. The study team will collect discarded thymus tissue from participants in the Cardiac surgery cohort. All participants will be requested to complete a study questionnaire at each collection timepoint.

Interventions

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 f

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.

Sponsors

Children's Hospital Foundation
Lead SponsorCharities/Societies/Foundations

Eligibility

Sex/Gender
All
Age
0 to 18 Years
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 23, 2026