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ta65

This version was saved 12 years, 7 months ago View current version     Page history
Saved by Thomas Pickard
on August 11, 2011 at 11:07:36 pm
 

Added IRC, Oppenheimer links

DIYgenomics - TA-65 Oncology Study

Back to DIYgenomics.org

 

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


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

  • IRB
    • Academic partner
      • Sarah Josef, SF State
      • Julielynn Wong, SUNY
    • WIRB, IRC www.irb-irc.com
  • Informed consent
  • Regulatory issues, HIPAA, etc.
  • Ethical review

 

4. Recruit and confirm oncology contacts

 

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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