Appendix D. Ancillary Study Application Form
Title Page
Study Title
PI 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):
Revised August 21, 2015
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
NEPTUNE-STUDY@umich.edu.
Biopsy Cohort:
Adult
Biopsy Cohort:
Pediatric
cNEPTUNE
Cohort
Number 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 NEPTUNE-STUDY@umich.edu.
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
Plasma
available
Serum
available
24-hour Urine
available
Spot Urine
available
DNA
available
RNA
available
Unstained section
available
Base
line
4
Mos.
8
Mos.
12
Mos.
18
Mos.
24
Mos.
30
Mos.
36
Mos.
42
Mos.
48
Mos.
54-60
Mos.
Please specify required sample storage conditions:
Revised August 21, 2015
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
6c.
Visit (Time)
Visit (Time)
Visit (Time)
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
Revised August 21, 2015
Part 2. Study Design (5 page limit excluding references)
1. Background and Rationale
2. Hypotheses and Specific Aims
3. Design and Methods
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.
4. Statistical Analysis
a. Power analysis and sample size justification
b. A detailed plan for data analysis
5. Anticipated Results and Project Timeline
6. Data Sharing Plan
The NEPTUNE Ancillary Studies Policy states that all data from ancillary studies will be made
available to the larger NEPTUNE consortium. At the conclusion of the data analysis and
publication of the main ancillary study hypothesis, or 24 months after transfer of samples or data
sets, the ancillary investigator shall send the newly collected data and/or laboratory results to
the NEPTUNE DACC. Once transferred to the DACC, all ancillary data will become part of the
aggregate NEPTUNE data and available to NEPTUNE participant sites and other requesting
third parties (via tranSMART or other ancillary study). Subsequent access to these data will be
governed by the NIH ORD data sharing policies. Any requested period of exclusivity for the data
generated by the ancillary study must be documented in the study proposal.
I agree to the NEPTUNE Data Sharing Policy (Please sign):
Part 3. References (limited to 15 maximum)
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 Blood
Serum
SST
Na
EDTASamples by Typea
Na Cit
Epib
SST
Epib
Hepb
EDTA
iced
Adult: Baseline Approx
Volume (mL)
3.2
3.6
4.8
3.6
2.4
27.2
4.8
Peds > 52 lbs: Baseline
Approx Volume (mL)
3.2
3.6
4.8
3.6
2.4
22.4
3.2
Peds 21-51 lbs: Basline
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
b Epi indicates samples procured for light sensitive product, stored in light sensitive eppendorf tubes
c Volume variable
Urine 24h & Spot Baseline & Follow-up
50mL
Falcon
Whole urine samples Per Participant
5 mL
aliquots:
2
Whole
urined
NaN3 - #
SN:
RNA-L
# pellet
PI - # SN
PI –
# pellet:
d Whole
90
4
4
2
4
2
6.4
6.4
-
0
-
Na Cit
Serum
Epib
SST
SST
Epib
Na
Hepb
EDTA
EDTAiced
3.2
1.2
4.8
1.2
1.2
17.6
4.8
3.2
3.6
4.8
3.6
2.4
9.6
3.2
3.2
3.6
0
3.6
2.4
8
0
0
1.2
0
1.2
1.2
4.8
0
5
Clean catch spot Per Participant
Total Volume
Follow-up Blood
Samples by Typea
Adult: Follow-up
Approx Volume (mL)
Peds > 52 lbs: FU
Approx Volume (mL)
Peds 21-51 lbs: FU
Approx Volume (mL)
Peds < 21 lbs: FU
Approx Volume (mL)
20
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
Na Cit
Serum Epi
SST
SST Epi
Na Hep
EDTA
50 mL Falcon
5 mL aliquots
Whole urine
NaN3 # SN
RNA-L # Pellet
PI - # SN
PI - # Pellet
Sample Type
Sodium Citrate
Serum, light sensitive
SST
SST, light sensitive
Sodium Heparin
Ethylenediaminetetraacetic Acid
24 hour urine, 1-50mL unprocessed whole urine, 1-50 mL whole urine with protease inhibitor cocktail
24 hour urine, 5-5mL unprocessed whole urine
Spot sample, 2 mL unprocessed whole urine
Spot sample, 2 mL spun supernatant with sodium azide
Spot sample, 2 mL spun pellet stored in RNA-Later
Spot sample, 2 mL spun supernatant with protease inhibitor cocktail
Spot sample, 2 mL spun pellet, treated with protease inhibitor cocktail, stored in RNA-Later
Revised August 21, 2015