Proposal for CARDIA Ancillary Study
Appendix C. Concept Form
Title Page
Study TitlePI Name
Affiliation
E-mail Address
Mailing Address
Co-Investigators’ Names
Proposed Start date
Proposed End date
Funding Source and
Application Date: / Internal funds from your own institution
Neptune Pilot funding
NephCure Kidney International-NEPTUNE Ancillary Studies Grant Program
Private sector funding (specify source)
Extramural/Intramural Funding
If already funded, specify agency and grant number:
If planned submission, specify agency and application date:
Abstract (limit to one paragraph):
Part 1. Feasibility
1. Define the patient population for your ancillary study, including inclusion and exclusion requirements.
2. 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 .
Biopsy Cohort: Adult / Biopsy Cohort: Pediatric / cNEPTUNE CohortNumber of participants:
3. 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 .
4. 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 Sequence /Biopsy / Base
line / 4
Mos. / 8
Mos. / 12
Mos. / 18
Mos. / 24
Mos. / 30
Mos. / 36
Mos. / 42
Mos. / 48
Mos. / 54-60 Mos. /
Plasma
available
Serum
available
24-hour Urine
available
Spot Urine
available
DNA
available
RNA
available
Unstained section
available
Please specify required sample storage conditions:
5. Will you need a statistician or data analyst from the DACC for you proposed ancillary study?
YES / / The DACC will contact you to set up a time to discuss the details of the biostatistical support and will generate a cost estimate.NO / / Please provide a description of the biostatistical expertise that will be available from your team for this proposed study.
6. Does your proposed study involve additional study visits, procedures or specimen acquisition beyond the core NEPTUNE protocol?
YES NO GO TO Part 2. Study Design, next page.
6a. 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).
Procedure / Visit (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 Time
Part 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. 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.
b. 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.
c. 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.
d. 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.
Revised August 21, 2015
Attachment 1. Original Sample Collections during Longitudinal Study
The tables below show the samples and quantities requested at each visit in NEPTUNE study. Please note that actual amounts may vary.
Baseline BloodSamples by Typea / Na Cit / Serum Epib / SST / SST
Epib / Na Hepb / EDTA / EDTA-iced / Follow-up Blood
Samples by Typea / Na Cit / Serum Epib / SST / SST
Epib / Na Hepb / EDTA / EDTA-iced
Adult: Baseline Approx Volume (mL) / 3.2 / 3.6 / 4.8 / 3.6 / 2.4 / 27.2 / 4.8 / Adult: Follow-up
Approx Volume (mL) / 3.2 / 1.2 / 4.8 / 1.2 / 1.2 / 17.6 / 4.8
Peds > 52 lbs: Baseline Approx Volume (mL) / 3.2 / 3.6 / 4.8 / 3.6 / 2.4 / 22.4 / 3.2 / Peds > 52 lbs: FU
Approx Volume (mL) / 3.2 / 3.6 / 4.8 / 3.6 / 2.4 / 9.6 / 3.2
Peds 21-51 lbs: Basline Approx Volume (mL) / 3.2 / 3.6 / 0 / 3.6 / 2.4 / 8 / 0 / Peds 21-51 lbs: FU
Approx Volume (mL) / 3.2 / 3.6 / 0 / 3.6 / 2.4 / 8 / 0
Peds < 21 lbs: Baseline Approx Volume (mL) / 0 / 1.2 / 0 / 1.2 / 1.2 / 4.8 / 0 / Peds < 21 lbs: FU
Approx Volume (mL) / 0 / 1.2 / 0 / 1.2 / 1.2 / 4.8 / 0
b Epi indicates samples procured for light sensitive product, stored in light sensitive eppendorf tubes
c Volume variable
Urine 24h & Spot Baseline & Follow-up / 50mLFalcon / 5 mL
aliquots: / Whole urined / NaN3 - # SN: / RNA-L
# pellet / PI - # SN / PI –
# pellet:
Whole urine samples Per Participant / 2 / 5
Clean catch spot Per Participant / 4 / 4 / 2 / 4 / 2
Total Volume / 90 / 20 / 6.4 / 6.4 / - / 0 / -
d Whole urine spot samples collected only if >60 mL sample obtained
Columns 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.
Abbrev Sample Type
Na Cit Sodium Citrate
Serum Epi Serum, light sensitive
SST SST
SST Epi SST, light sensitive
Na Hep Sodium Heparin
EDTA Ethylenediaminetetraacetic Acid
50 mL Falcon 24 hour urine, 1-50mL unprocessed whole urine, 1-50 mL whole urine with protease inhibitor cocktail
5 mL aliquots 24 hour urine, 5-5mL unprocessed whole urine
Whole urine Spot sample, 2 mL unprocessed whole urine
NaN3 # SN Spot sample, 2 mL spun supernatant with sodium azide
RNA-L # Pellet Spot sample, 2 mL spun pellet stored in RNA-Later
PI - # SN Spot sample, 2 mL spun supernatant with protease inhibitor cocktail
PI - # Pellet Spot sample, 2 mL spun pellet, treated with protease inhibitor cocktail, stored in RNA-Later
Revised August 21, 2015