Implementing Precision Medicine for Glomerular Diseases in the Nephrotic Syndrome Study Network (NEPTUNE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 375
- 试验地点
- 16
- 主要终点
- Matched participants with at least one clinical trial receive a MNB assessment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
No Masking
入排标准
- 年龄范围
- 1 Year 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
NEPTUNE Match Participants
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.
干预措施: Communication (Other)
结局指标
主要结局
Matched participants with at least one clinical trial receive a MNB assessment
时间窗: 0-4 weeks
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
Efficacy of communication methods at time of communication visit, measured by Teach Back 1 summary score
时间窗: 12 weeks
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.
Kidney health endpoints that are specific to each individual trial
时间窗: 0-60 months
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.
次要结局
- Psychological distress measured by the FACToR-NEPTUNE assessment(14-18 weeks)
- Efficacy of communication methods at follow up, measured by Teach Back of key concepts(14-18 weeks)
- Psychological distress measured by the STAI assessment(14-18 weeks)
研究者
Matthias Kretzler
Internal Medicine Professor
University of Michigan