NEPTUNE Match Study

Study Overview
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Brief Summary
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NEPTUNE Match is an additional opportunity offered to NEPTUNE study participants to prospectively recruit and communicate patient-specific clinical trial matching with kidney patients and their physician investigators.

Detailed Description
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This is a prospective, open-label study testing the ability to effectively communicate patient-specific clinical trial matching with kidney patients and clinician investigators. The study consists of four components: Recruitment of participants from the NEPTUNE observational cohort study Generation of participant profile-trial match assessment using data from the NEPTUNE observational study and profiling units by the NEPTUNE Molecular Nephrology Board Establishing and testing a framework to communicate disease-trial drug mechanism matching with investigators and patients Retrospective comparison of kidney health outcomes in subjects enrolled in trials that aligned with their match vs. trial subjects with mis-aligned or unknown match alignment.

Official Title
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Nephrotic Syndrome Study Network (NEPTUNE) Match Study

Conditions
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Nephrotic Syndrome in Children, Focal Segmental Glomerulosclerosis, Minimal Change Disease, Minimal Change Nephrotic Syndrome, Membranous Nephropathy, FSGS, MCD, MCD - Minimal Change Disease

Intervention / Treatment
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* Other: Communication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consented and eligible participants in the biopsied or non-biopsied cohorts of the NEPTUNE observational study Must be potentially eligible for the NEPTUNE Match partnering trials (e.g. if no trial is enrolling a participant under age 6, those under 6 are not eligible). Note: NEPTUNE Match partnering trials and associated eligibility criteria are expected to be dynamic and change as trial protocols are developed, activated, and amended. Regular nephrology healthcare provided at a NEPTUNE study site. Willing and able to consent, and as appropriate assent, to participate in NEPTUNE Match Exclusion Criteria: Currently non-NEPTUNE observational study participants are not eligible to be matched to a clinical trial using these biomarker assessments. Exclusion Criteria: 1. Non-English or non-Spanish speaking

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NEPTUNE Match Participants<br>Approximately 375 participants will be consented from the NEPTUNE observational study with age and demographic groups representing the patient population in the NEPTUNE study site geographical areas. NEPTUNE observational cohort eligibility includes: participants in NEPTUNE observational cohort A are of any age and have a biopsy-confirmed diagnosis of Focal Segmental Glomerulosclerosis (FSGS), Minimal Change Disease (MCD), or Membranous Nephropathy (MN). Participants in NEPTUNE observational cohort B have documented NS based on proteinuria, serum albumin, and/or edema with age of onset less than 19 years. | Other: Communication<br>* The NEPTUNE Match study includes an interdisciplinary Communication Team that will translate findings from the Molecular Nephrology Board (MNB) to inform patients of the matching assessment with ongoing clinical trials. This team has considerable experience with conveying complex biomedical research information to patients and families and includes experts in precision nephrology, nephrology patient [adult and pediatric] communication, and health education.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Matched participants with at least one clinical trial receive a MNB assessment | Proportion of NEPTUNE Match participants with at least one matching clinical trial, defined as receiving a Molecular Nephrology Board (MNB) assessment that provides a match to at least one targeted therapy in an ongoing clinical trial | 0-4 weeks | 
| Efficacy of communication methods at time of communication visit, measured by Teach Back 1 summary score | Key findings from MNB trial matching analyses and deliberations will be conveyed to study participants using a NEPTUNE Match Report that summarizes the findings. The report indicates the strength of matching to ongoing clinical trials and the uncertainty and research origins of the information. A sample Match Report can be found in Appendix C. The report will not contain individual data elements reviewed by the MNB. The creation of NEPTUNE Match Reports will follow health education principles including matching of content to patients' informational needs and health literacy levels, use of visual aids to clarify meaning of information, and avoidance of information overload of the participant. | 12 weeks | 
| Kidney health endpoints that are specific to each individual trial | The analytic integration supporting the Molecular Nephrology Board (MNB) case review will be initiated and will occur. The MNB will conduct the discussion and generate the integrated data summary and case report inclusive of clinical trial matching by webinar. Input from the MNB will be used to generate a final version of the participant NEPTUNE Match Report. This is a longitudinal outcome that will be assessed at the end of the study relative to endpoints specific to matched clinical trials, assessing the superiority of stratification (matching or alignment of patient molecular profiles to targeted therapies in clinical trials) to non-stratification. | 0-60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of communication methods at follow up, measured by Teach Back of key concepts | 3 defined teachback concepts will be scored to indicate the participant's understanding of strength of matching. | 14-18 weeks | 
| Psychological distress measured by the STAI assessment | State Trait Anxiety Inventory (mini-STAI) scale will be used to assess a participant's psychological distress around their participation in NEPTUNE Match at the consent visit and the follow up visit. | 14-18 weeks | 
| Psychological distress measured by the FACToR-NEPTUNE assessment | FACToR-NEPTUNE is a measure that has been modified from the Feelings About genomiC Testing Results (FACToR). FACToR-12 is used to assess the psychosocial impact of returning genomic findings to patients in research and clinical practice. In the FACToR-NEPTUNE assessment the measure will assess the psychosocial impact after receiving the NEPTUNE Match Report. | 14-18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nephrotic Syndrome, NEPTUNE, Match, Clinical Trial Match