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Sample management (1)

The short term effects of an AKT inhibitor (AZD5363) on biomarkers of the AKT pathway and anti-tumour activity in a breast cancer paired biopsy study (STAKT trial) Sample Management.

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Sample management (1)

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  1. The short term effects of an AKT inhibitor (AZD5363) on biomarkers of the AKT pathway and anti-tumour activity in a breast cancer paired biopsy study (STAKT trial) Sample Management Mr Kwok-Leung Cheung Clinical Associate Professor University of Nottingham STAKT Trial Co-investigator Alison McKendry Project Manager Quintiles

  2. Sample management (1) • Essentially a ‘paired biopsy study’ • Many samples – a) Tumour tissues (FFPE +/- fresh frozen) b) Platelet rich plasma (PRP) c) Pharmacokinetic (PK) plasma d) Hair (eyebrow) • Many laboratories

  3. Sample management (2) • Sponsor – University of Nottingham • Central laboratory – Quintiles • Other laboratories – a) Histopathology, Royal Derby Hospital b) Tenovus Institute, Cardiff c) University of Nottingham d) Other external laboratories

  4. Sample management (3) – Pathway Site A Tenovus Cardiff Derby – Pathology review and sectioning FFPE Site B Covance PK plasma Central Lab (Quintiles) Serum Site C Nottingham Bank Frozen tissue Hair PRP Site D ICR

  5. Sample management (4) • All specimens (tumour and others) are sent to Quintiles as the central laboratory. • Centralised tracking system of all specimens going in and out of Quintiles. • A single manual on sample logistics covers the whole pathway and all procedures regardless of individual laboratory involvements.

  6. Tumour sample management (1) • 2 tumour blocks are to be sent, one from the diagnostic core biopsy and the second from the post-treatment core biopsy (can be obtained from the operative specimen). • A standard validated FFPE protocol should be used – including taking multiple cores, immediate fixation in formalin, minimum fixation of 6 hrs, processing into one block to be sent etc.

  7. Tumour sample management (2) • Site  Quintiles central laboratory • Quintiles central lab  Derby Histopathology (for pathology review and sectioning) • Derby Histopathology  Tenovus @ Cardiff (for biomarker measurements) • Separate tracking between Derby and Cardiff

  8. Management of other samples • Site  Quintiles central laboratory external labs as appropriate

  9. ?

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