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Tumor tissue samples from primary lesions and/or biopsy material will be collected and centralized assessment.
Inclusion criteria 1) Age 11 to 16 years; 2) T1diagnoseded for more than 1 year or C-peptide negative; 3) Centralized assessment of ACR based on six early morning urines deemed to be in upper tertile for risk after adjustment for age, gender, age at diagnosis and duration of disease.
Inclusion and exclusion criteria Inclusion criteria 1) Age 11 to 16 years; 2) T1diagnoseded for more than 1 year or C-peptide negative; 3) Centralized assessment of ACR based on six early morning urines deemed to be in middle or lower tertiles for risk after adjustment for age, gender, age at diagnosis and duration of disease.
No centralized assessment of laboratory tests was foreseen.
The subjects approached in the UK, Canada and Australia have already consented to screening through centralized assessment of ACR in three consecutive early morning urines.
Anonymised digital copies of the most recent retinal photographs, performed as part of the annual routine screening, will be collected and retained for centralized assessment.
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Anonymised digital copies of the most recent retinal photographs, performed as part of the routine annual screening, will be also collected for centralized assessments.
The WellChild laboratory at The Evelina Children's Hospital, London will undertake centralized assessments of all urinary screening samples, 6 monthly study urine samples and bloods for HbA1c, creatinine, SDMA, cystatin C, fasting lipids, lipoproteins, ADMA, and hsCRP.
These assessments will include: cIMT (and FMD, EndoPAT and PWV where facilities allow), blood samples for lipids and lipoproteins, CVD risk markers, SDMA, creatinine, cystatin C, three early morning urines for ACR and collection of anonymised digital copies of the most recent retinal photographs, performed as part of the annual routine screening, for centralized assessments.
Following this integration, Northwell was able to create a unified patient registry, offering a billion data points, and can practice centralized risk assessment, patient engagement and remote patient monitoring.
This assessment will be centralized and carried out independently and blindly (without knowing the treatment arms) by 2 of the 3 members of our Central Review Committee of Pathology.
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