Ancillary Studies

NEPTUNE welcomes and encourages investigators within and external to the network to use the observational clinical data, histopathology data, biosamples, whole slide images, and derived data sets from NEPTUNE patients for their own research. Investigators can also access NEPTUNE study participants to collect new data or biospecimens; or perform observational or interventional studies.

The NEPTUNE Ancillary Studies Program provides the mechanism for sharing NEPTUNE data and materials. This program is at the heart of the NEPTUNE mission as we consider NEPTUNE’s lasting impact on advancing the science of glomerular disease contingent on its ability to share its resources.

Ancillary studies using biospeciments, the NEPTUNE Digital Pathology Repository, or requesting access to NEPTUNE patients is subject to review by the NEPTUNE Ancillary Studies Committee

The main goal of the ancillary study review process is to ensure minimal burden to study participants and biorepository, manage project scope overlapy, and assess prudent use of limited NEPTUNE resources.

Note: Approved Ancillary Studies Collaborators will be expected to uphold the Ancillary Studies Policy

Biospecimens available for ancillary studies

The below tables show the biospecimens collected at study visits:
Blood
Serum/plasma samples
Plasma
(Sodium Citrate)
Serum
Serum
(SST)
Serum
(Sodium Heparin)
Serum
(EDTA)
Baseline
Adult
Peds > 52 lbs.
Peds 21-51 lbs.
Peds < 21 lbs.
Follow-up
Adult
Peds > 52 lbs.
Peds 21-51 lbs.
Peds < 21 lbs.
Urine
24-hr urine
(untreated)
24-hr urine
(PI)
Spot urine (PI)
Spot urine
(NaN3)
Spot urine pellets in RNA later
Spot urine pellets
(PI)
Baseline (all participants)
Follow-up (all participants)
A complete guide of all of the data available can be found here

Datasets available for Ancillary Studies

Data category
Baseline visit
Follow-up visits
Demographics
Follow-up (all participants)
Census tracts
Socio-economic status
Healthcare utilization
Renal function and proteinuria
Lab results
Patient-reported data
Endpoints
APOL1 risk haplotype
Nephrotic syndrome classification data
Family medical history
Medications
A complete guide of all of the data available can be found here

Explore the NEPTUNE databases through tranSMART!

NEPTUNE tranSMART is a web-based platform that provides available clinical, biospecimen, and biomarker data in an organized ontology.

Contact neptune-study@umich.edu to gain access.

How to Submit an Ancillary Study Application

An ancillary study proposal should be submitted to the NEPTUNE Ancillary Studies Committee 8-10 weeks prior to the anticipated date of submission for external funding.

Completed forms can be submitted to neptune-study@umich.edu.

The review process

NEPTUNE ancillary study review process figrure
The proposed study must:
  1. Not interfere with the completion of the main objectives of NEPTUNE or with continued study participant participation and adherence to the NEPTUNE protocol and policies.
  2. Have adequate resources to effectively carry out the project, including sufficient budget and staff with requisite expertise.
  3. Be subject to a pre-determined, external peer review by an external funding organization.
    If the nature of the proposed study is not subject to a pre-determined, external peer review (e.g. an NIH study section) by an external funding organization, the proposal will undergo a rigorous external peer review managed by the NEPTUNE Ancillary Studies Committee

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