NEPTUNE Match Study

N/AEnrolling By InvitationNCT04571658

University of Michigan375 enrolled

Overview

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.

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: 1. Recruitment of participants from the NEPTUNE observational cohort study 2. Generation of participant profile-trial match assessment using data from the NEPTUNE observational study and profiling units by the NEPTUNE Molecular Nephrology Board 3. Establishing and testing a framework to communicate disease-trial drug mechanism matching with investigators and patients 4. 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.

Study Type

OBSERVATIONAL

Enrollment

375

Conditions

Nephrotic Syndrome in Children Focal Segmental Glomerulosclerosis Minimal Change Disease Minimal Change Nephrotic Syndrome Membranous Nephropathy

Interventions

CommunicationOTHER

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.

Eligibility

Sex: ALLMin age: 1 YearMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Consented and eligible participants in the biopsied or non-biopsied cohorts of the NEPTUNE observational study 2. 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. 3. Regular nephrology healthcare provided at a NEPTUNE study site. 4. 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

Locations (16)

Emory University Hospital - Children's Hospital of Atlanta

Atlanta, Georgia, United States

John H. Stroger, Jr., Hospital of Cook County

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Johns Hopkins Medicine

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Northwell/Cohen's Children's Hospital

New Hyde Park, New York, United States

Columbia University Medical Center

New York, New York, United States

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

...and 6 more locations

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 0-60 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 14-18 weeks