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Report of IBDC Breakout Session on Clinical Samples and Mouse Models

Report of IBDC Breakout Session on Clinical Samples and Mouse Models. IBDC Conference FHCRC, Seattle, WA, USA 12 October 2005. Yu-Sun Chang (Chang-Gung U) Judith Clements (QueenslandUTSLS) Michael Davis (FHCRC) Ken Evans (OCBN) Michael Gillette (Broad) Chris Kemp (FHCRC)

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Report of IBDC Breakout Session on Clinical Samples and Mouse Models

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  1. Report of IBDC Breakout Session on Clinical Samples and Mouse Models IBDC Conference FHCRC, Seattle, WA, USA 12 October 2005

  2. Yu-Sun Chang (Chang-Gung U) Judith Clements (QueenslandUTSLS) Michael Davis (FHCRC) Ken Evans (OCBN) Michael Gillette (Broad) Chris Kemp (FHCRC) Jeong Heon Ko (KRIBB) Cheolju Lee (KIST) Lance Miller (GIS) Hal Moses (Vanderbilt) Nallisivam Palanisamy (GIS) Incheol Shin (Hanyang U) Khay-Guan Yeoh (U Singapore) Participants

  3. Mandate • “The clinical members should identify best procedures for tissue procurement and handling. The mouse experts should identify best mouse models for human cancer and optimum experimental paradigms for identifying mouse biomarkers for disease and cross correlating them with human biomarkers.”

  4. Mouse Models • “Eliminate Red Herrings” • FHCRC (McIntosh / Paulovich / Kemp) dedicated to defining ideal characteristics of mouse models, sample acquisition, storage, processing • FHCRC standards and protocols available from Chris Kemp (cjkemp@fhcrc.org)

  5. Sample Materials • Need for best practices and detailed protocols • Prospective Collection • Blood products • Plasma • Serum • Urine • Tumor tissue • Representative sections for HP review • Details per tumor type & project requirement • “Pure” tumor vs. tumor with margins • Heterogenous tumors (prostate) especially difficult case • Disease specific materials: “proximal fluids” • Gastric Juice (gastric ca); Semen (prostate ca); pancreatic ductal lavage (pancreatic ca); CSF (CNS malignancy)

  6. Plasma • Ultimately BMs must survive vagaries of clinical laboratories • Discovery particularly challenging; standards more rigorous • Citrate or EDTA, not heparinized tubes • Ideally single vendor, single lot • Plan aliquots carefully at inception • Available volume; requirements for intended applications; storage constraints; FT minimization • Consider “moderate” initial aliquots, eg 0.5 – 1 mL, allowing single FT cycle for subaliquots • -80° C standard for storage

  7. All samples • Barcoding from time of initial sample collection • System should track all steps in sample handling & processing (21 CFR adherence) • SOP adherence complemented by careful documentation of collection / storage parameters for each sample (stopwatch in OR) • Samples may be used for initial validation as well as discovery • Regulatory compliance: Agencies care about details • *Rigorous adherence to GCP / GLP / GMP (Good Clinical / Laboratory / Manufacturing Practice)

  8. Controls critical • Always imperfect; often inadequate • Project-specific controls • Minimize site / batch signatures • Plasma requires “suitably matched” controls • Healthy • Confounding disease • Tumor – consider multiple “orthogonal” controls • Distant histopathologically uninvolved (“non-tumor”) • Contralateral uninvolved (eg prophylactic mastectomy) • Non-malignant diseased • “Healthy” • Other malignant

  9. The only missteps that are unrecoverable are those related to sample collection, storage, & annotation • IBDC standing committee for sample collection & storage • Review / incorporate / disseminate best practices & protocols • ? Limited empiric assessment across consortium • IBDC prospective longitudinal collection of carefully annotated plasma / urine samples dedicated to BM validation (cf Women’s health initiative, nurses health study)

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