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DIYgenomics - TA-65 Oncology Study

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Study Protocol


1. Confirm immunology protocol and recruit immunology advisors

  • Key questions
    • Is this the correct protocol (positive structure/function), what is missing, what would be logically measured
    • Effect was most pronounced in CMV+ individuals
  • Contacts
    • Monica Ranes-Goldberg, Immunology Professor, UCSC (8/3, call 8/10)
    • Daniel Kraft, Stanford Stem Cell Research (8/3)
    • Mark Hamalainen, Halcyon Molecular (8/3)
    • Mark M Davis, Dir Stanford Inst for Immunology
    • Chris Hogg, Gilean (8/3, no immediate contacts)
  • Cancer and telomere contacts


2. Recruit CROs

  • Accelovance, Inc.
  • Acme Bioscience, Inc.
  • BASi
  • Huntington Life Sciences
  • Integrium, LLC
  • ISIS Services, LL
  • Novella Clinical
  • ProteoSource, LLC
  • Quintiles Transnational Corporation
  • Tandem Sciences, Inc.
  • Teikoku Pharma USA, Inc.
  • assaydepot.com

3. Determine IRB (Institutional Review Board) strategy, informed consent, regulatory concerns, ethics, etc.

  • IRB
    • Academic partner
      • Sarah Joseph, SF State
      • Julielynn Wong, SUNY
    • WIRB, IRC
  • Informed consent
  • Regulatory issues, HIPAA, etc.
  • Ethical review


4. Recruit and confirm oncology contacts

  • Prostate cancer - Jonathan Oppenheimer
  • Breast (and ovarian?) cancer - Susan J Love Foundation representative


5. Develop protocol

  • Locate templates and/or examples of other study protocols
    • Cancer immunology trials from www.clinicaltrials.gov,
    • Identify relevant categories
      • Purpose
      • Function
      • Rationale
      • Design
      • Participants
      • Intervention
      • Demographics
      • Design
      • Endpoints
    • Complete protocol draft


6. Budget

  • Intervention - TA-65
  • Testing - blood sample collection and shipping, UCLA immunology tests, TelomeHealth critically-short telomere-length testing and storage, 23andMe genotyping 
  • Staff time - study planning, administration
  • Publication cost (if open-access journal selected (PLoSOne $1350, JMIR $1900)


Background information


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