Eligibility information
Inclusion criteria
- Paediatric and adult patients with atopic eczema who due to the severity of their disease and/or impact on quality of life are commencing on or switching to another systemic immuno-modulatory agent (e.g. CyA, AZA, MTX or biologic treatments).
- Written informed consent for study participation obtained from the patient or parents / legal guardian, with assent as appropriate by the patient, depending on the level of understanding.
Participants consent to participate in long-term follow up and access to all medical records, including hospital admission records and linkage to data held by NHS bodies or other national providers of healthcare data. - Diagnosis of atopic eczema in keeping with the UK/Irish diagnostic criteria.
- Willingness to comply with all study requirements.
- Competent use of English language, according to patient’s age (capable of understanding patient questionnaires
Exclusion Criteria
- Insufficient understanding of the study by the patient and/or parent/guardian.
- Patients who are currently participating in a randomised clinical trial.
Adverse event reporting
| Event | When | How | To whom |
|---|---|---|---|
| All adverse events | Anytime | Via electronic CRF | Study co-ordinating centre |
| Drug-related serious adverse reactions and Adverse reactions for medicines under additional monitoring | Anytime | Electronic submission through:
Study Co-ordinating centre: eCRF | MHRA (UK) or HPRA (Ireland). Study co-ordinating centre |
Investigator site file checklist
| ISF section | Document name | Current version | Date |
|---|---|---|---|
| 1 | File Note Log ASTAR V1 13Aug18 | N/A | 13-Aug-2018 |
| 2 | Study Contact List | 6 | 01-May-2023 |
| 3 | Current approved protocol | 4.1 | 12-Mar-2024 |
| 4 | Initial REC Approval | N/A | 26-Jul-2018 |
| 4 | Substantial Amendment 1 | N/A | 28-Mar-2019 |
| 4 | Substantial Amendment 2 | N/A | 05-Jan-2022 |
| 4 | Substantial Amendment 3 | N/A | 10-Feb-2023 |
| 5 | Substantial Amendment 4 | N/A | 11-Sep-2024 |
| 5 | Initial HRA Approval | N/A | 09-Aug-2018 |
| 7 | Insurance and Indemnity Statement | VOI 2024-25 | 01-Aug-2024 |
| 8 | Site Staff Delegation Log | 2.1 | 23-Aug-2023 |
| 8 | Site Staff Training log | 1.1 | 13-Mar-2019 |
| 8 | A-STAR Skin examination protocol | 1 | N/A |
| 8 | A-STAR Recruitment Poster | 1 | 01-Jul-2022 |
Current Approved Main Consent Forms
| ISF section | Document name | Current version | Date |
|---|---|---|---|
| 9 | Adult PIS – ICF | 2.00 | 01-Feb-2019 |
| 9 | Children PIS – ICF | 2.00 | 01-Feb-2019 |
| 9 | Young Person PIS – ICF | 2.00 | 01-Feb-2019 |
| 9 | Very Young Person PIS – ICF | 2.00 | 01-Feb-2019 |
| 9 | Parent and Guardian PIS – ICF | 2.00 | 01-Feb-2019 |
Current approved Biorepository PIS-ICF
| ISF section | Document name | Current version | Date |
|---|---|---|---|
| 9 | Adult PIS – ICF | 3.2 | 20 May 2024 |
| 9 | Children PIS – ICF | 2.0 | 01 Feb 2019 |
| 9 | Young Person PIS – ICF | 3.0 | 09 Aug 2021 |
| 9 | Very Young Person PIS – ICF | 2.0 | 01 Feb 2019 |
| 9 | Parent and Guardian PIS – ICF | 3.2 | 20 May 2024 |
Current approved withdrawal forms:
| ISF section | Document name | Current version | Date |
|---|---|---|---|
| 9 | Patient withdrawal form | 2.0 | 01 Feb 2019 |
| 9 | Minor and carer withdrawal form | 2.0 | 01 Feb 2019 |
Current A-STAR Case Report Forms:
| ISF section | Document name | Current version | Date |
|---|---|---|---|
| 12 | Adverse Events CRF | 3.0 | 01-May-2023 |
| 12 | Baseline CRF | 3.0 | 01-May-2023 |
| 12 | Concomitant Medication CRF | 3.0 | 01-May-2023 |
| 12 | Current Phototherapy CRF | 3.0 | 01-May-2023 |
| 12 | Current Topical Therapy CRF | 3.0 | 01-May-2023 |
| 12 | End of Study CRF | 3.0 | 01-May-2023 |
| 12 | Follow-Up Visit CRF | 3.0 | 01-May-2023 |
| 12 | New Systemic Therapy CRF | 3.0 | 01-May-2023 |
| 12 | Safety Tests CRF | 3.0 | 01-May-2023 |
| ISF section | Document name | Current version | Date |
|---|---|---|---|
| 12 | Current Bioresource Samples CRF | 1.0 | 01 Jul 2022 |
| 12 | eCRF completion guidance | 1.03 | 26 Jun 2022 |
Blank POEM questionnaires
| ISF section | Document name | Current version | Date |
|---|---|---|---|
| 12 | POEM for self-completion | 1.0 | 18 Jul 2018 |
| 12 | POEM for proxy completion | 1.0 | 18 Jul 2018 |
Blank QoL questionnaires
| ISF section | Document name | Current version | Date |
|---|---|---|---|
| 12 | CDLQI | 1.0 | 18 Jul 2018 |
| 12 | CDLQI Cartoon version | 1.0 | 16 Oct 2018 |
| 12 | DLQI | 1.0 | 18 Jul 2018 |
| 12 | IDQOL | 1.0 | 18 Jul 2018 |
Blank EQ-5D questionnaires
| ISF Section | Document name | Current version | Date |
|---|---|---|---|
| 10 | EQ-5D-5L | 2.0 | 06 Dec 2018 |
| 10 | EQ-5D-Y | 1.0 | 13 Aug 2018 |
| 10 | EQ-5D-Y PROXY | 2.0 | 06 Dec 2018 |
| ISF section | Document name | Current version | Date |
|---|---|---|---|
| 12 | Blank Itch severity score questionnaire: (Modified for A-STAR Study) Itch Severity Index | 1.0 | 30-JAN-2019 |
| 12 | Blank Asthma Control Test questionnaire: (Modified for A-STAR Study) | 1.0 | 24-AUG-2018 |
| 12 | Blank EASI: (Modified for A-STAR Study) | 2.0 | 09-OCT-2018 |
| 12 | Blank Validated Investigator Global Assessment Scale vIGA: (Modified for A-STAR Study) | N/A | 2017 |
| 13 | DNA Lab Manual | 2.0 | 01-MAY-2023 |
| 13 | Bioresource Laboratory Manual | 1.1 | 16-OCT-2023 |
| 13 | A-STAR Sample labels | N/A | N/A |
| 13 | Shipment address labels | N/A | N/A |
| 13 | Sample and Freezer Storage Log | 1.0 | 16-APR-2021 |
| 13 | DNA Sample Shipping Form | 2.0 | 01-MAY-2023 |
| 13 | CAPTURE Manual | 2.1 | 16-DEC-2020 |
| 13 | CAPTURE Request Forms | 1.2 | 02-APR-2019 |
| 14 | Monitoring Visit Log | 2.0 | 16-MAR-2021 |
| 14 | Source Document Location List | 1.0 | 28-JUN-2021 |
Fieldworker Test
If a clinician is directly involved in making the decision to enrol patients into A-STAR, please can they carry out the following online diagnosis test:
Eczema diagnosis manual, including fieldworker test (read the sections on the UK diagnostic criteria, look at the 48 training photographs (Section 1.3 The UK diagnostic criteria for atopic eczema; Section 3.2. The sign of flexural dermatitis) and then take the fieldworker test: ‘test photographs’, Appendix
Data monitoring
Tanzeem Begum (Clinical Research Associate)
St John’s Institute of Dermatology, Guy’s and St Thomas’ NHS Foundation Trust and King’s College London.
Rebecca Carroll (Data Manager)
St John’s Institute of Dermatology, Guy’s and St Thomas’ NHS Foundation Trust and King’s College London.
Contact us
Get in touch with the A-STAR team to ask any questions about the project
- Address
Get in touch with the A-STAR team to ask any questions about the project
Email A-STAR@GSTT.NHS.UK
Telephone 02071887188
Unit for Paediatric & Population-Based Dermatology Research, St John's Institute of Dermatology
