Proposal for CARDIA ancillary study - Home | Rare Diseases ...



2847975-18224500Appendix C. Concept FormTitle PageStudy TitlePI Name AffiliationE-mail AddressMailing AddressCo-Investigators’ NamesProposed Start dateProposed End dateFunding Source and Application Date: FORMCHECKBOX Internal funds from your own institution FORMCHECKBOX Neptune Pilot funding FORMCHECKBOX NephCure Kidney International-NEPTUNE Ancillary Studies Grant Program FORMCHECKBOX Private sector funding (specify source) FORMCHECKBOX Extramural/Intramural FundingIf already funded, specify agency and grant number:If planned submission, specify agency and application date:Abstract (limit to one paragraph):Part 1. FeasibilityDefine the patient population for your ancillary study, including inclusion and exclusion requirements.How many adult and pediatric NEPTUNE patients meet your study requirements defined in Question #1 above? We encourage you to use tranSMART or work with a DACC member to assess case counts for your study design. If you need access to TranSMART to review NEPTUNE data, please contact NEPTUNE-STUDY@umich.edu.Biopsy Cohort: AdultBiopsy Cohort: PediatriccNEPTUNE CohortNumber of participants:Summarize your request for existing clinical data, including visits. Please refer to tranSMART or the tranSMART ontology map for data collected at baseline and follow up visits. If you need access to tranSMART to review NEPTUNE data, please contact NEPTUNE-STUDY@umich.edu.In the table below, please indicate the amount of existing sample, at each visit, you are requesting for your proposed study population (#1 & #2 above). Please work with a DACC member to determine current availability in the NEPTUNE biorepositories.The Ancillary Studies Policy states that you should indicate the absolute minimum amount to complete your proposed study. Attachment 1 shows original sample collections during the longitudinal study period.If your proposed project will use samples in addition to NEPTUNE samples (e.g., controls from healthy subjects or people with other diseases), list them separately in the table by adding rows, as needed.Visit SequenceBiopsyBaseline4Mos.8Mos.12Mos.18Mos.24Mos.30Mos.36Mos.42Mos.48Mos.54-60 Mos.PlasmaavailableSerumavailable24-hour UrineavailableSpot UrineavailableDNAavailableRNAavailableUnstained sectionavailablePlease specify required sample storage conditions: Will you need a statistician or data analyst from the DACC for you proposed ancillary study? YES381011874500The DACC will contact you to set up a time to discuss the details of the biostatistical support and will generate a cost estimate.NO508017462500Please provide a description of the biostatistical expertise that will be available from your team for this proposed study.Does your proposed study involve additional study visits, procedures or specimen acquisition beyond the core NEPTUNE protocol? 16328898318500YESNOGO TO Part 2. Study Design, next page.3695703506006a.Describe the rationale for additional procedures or visits.6b.Use the table below to specify the proposed visit schedule and procedures (questionnaires, intervention, laboratory sampling and tests). Provide a subject level time estimate of additional study procedures (e.g. self-administered questionnaire x 10 minutes).ProcedureVisit (Time)Visit (Time)Visit (Time)?????????6c.If the ancillary study requires additional blood or urine beyond that collected in the NEPTUNE protocol please describe in table below:Specimen (Plasma, Serum, Urine, Other - specify)Sampling Times*:Volume Requested????????*Specify NEPTUNE Visit (N) Month 0, 4, 8, 12, etc. or specify Additional (A) Visit TimePart 2. Study Design 3.Design and Methods Describe: the plan for data acquisition; sample collection and handling; specific assays and experiments; planned quality control measures.If you are proposing use of limited biospecimens, please provide:A justification for the request of limited and irreplaceable biomaterials. The justification should discuss how the proposed project will take advantage of the depth of larger NEPTUNE clinical data set and it should make the case clearly that the proposed study will have significant scientific impact.Preliminary data to support the proposal’s hypothesis and the technical feasibility of the approach proposed. The ancillary studies committee may consider the use of NEPTUNE biosamples to develop preliminary data in an iterative fashion in some cases. In this case, explain why alternative samples cannot be obtained from other sources.Consideration of the source and condition of requested biospecimens, such as how they were collected, prepared and stored if this might affect the proposed analysis.Assay details and methodology, including: amounts and type of samples (applicants should request the minimum volume required for their assay), anticipated assay variability, quality control (assay "robustness") assessment. Attachment 1. Original Sample Collections during Longitudinal StudyThe tables below show the samples and quantities requested at each visit in NEPTUNE study. Please note that actual amounts may vary.Baseline BloodSamples by TypeaNa CitSerum EpibSSTSSTEpibNa HepbEDTAEDTA-iced?Follow-up BloodSamples by TypeaNa CitSerum EpibSSTSSTEpibNa HepbEDTAEDTA-icedAdult: Baseline Approx Volume (mL)3.23.64.83.62.427.24.8?Adult: Follow-up Approx Volume (mL)3.21.24.81.21.217.64.8Peds > 52 lbs: Baseline Approx Volume (mL)3.23.64.83.62.422.43.2?Peds > 52 lbs: FU Approx Volume (mL)3.23.64.83.62.49.63.2Peds 21-51 lbs: Basline Approx Volume (mL)3.23.603.62.480?Peds 21-51 lbs: FU Approx Volume (mL)3.23.603.62.480Peds < 21 lbs: Baseline Approx Volume (mL)01.201.21.24.80?Peds < 21 lbs: FU Approx Volume (mL)01.201.21.24.80b Epi indicates samples procured for light sensitive product, stored in light sensitive eppendorf tubesc Volume variableUrine 24h & Spot Baseline & Follow-up50mLFalcon5 mLaliquots:Whole urinedNaN3 - # SN:RNA-L# pelletPI - # SNPI –# pellet:Whole urine samples Per Participant25?????Clean catch spot Per Participant??44242Total Volume90206.46.4-0-d Whole urine spot samples collected only if >60 mL sample obtainedColumns specified with a specimen type (Na Cit, 50 mL Falcon, etc) indicate the amount accounted for in the Baseline Biospecimens CRF by research coordinators, collectively.AbbrevSample TypeNa CitSodium CitrateSerum EpiSerum, light sensitiveSSTSSTSST EpiSST, light sensitiveNa HepSodium HeparinEDTAEthylenediaminetetraacetic Acid50 mL Falcon24 hour urine, 1-50mL unprocessed whole urine, 1-50 mL whole urine with protease inhibitor cocktail5 mL aliquots24 hour urine, 5-5mL unprocessed whole urineWhole urineSpot sample, 2 mL unprocessed whole urineNaN3 # SNSpot sample, 2 mL spun supernatant with sodium azideRNA-L # PelletSpot sample, 2 mL spun pellet stored in RNA-LaterPI - # SNSpot sample, 2 mL spun supernatant with protease inhibitor cocktailPI - # PelletSpot sample, 2 mL spun pellet, treated with protease inhibitor cocktail, stored in RNA-Later ................
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