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
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