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

Not Applicable

• Conditions: Immune Diseases; Inflammatory and Immune System - Normal development and function of the immune system; Inflammatory and Immune System - Autoimmune diseases; Inflammatory and Immune System - Other inflammatory or immune system disorders; Inflammatory and Immune System - Allergies

• Registration Number: ACTRN12623000597695
• Lead Sponsor: Children's Hospital Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-31
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 1600

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified