Implementing GeNomics In pracTicE (IGNITE) Network is an NIH-funded network dedicated to supporting the implementation of genomics in healthcare. The network started as IGNITE Genomic Demonstration Projects (IGNITE GDP) and later became IGNITE Pragmatic Trials Network (IGNITE PTN).

Launched in 2013, the initial phase, IGNITE GDP (IGNITE I), focused on a consortium of collaborative genomic medicine pilot projects aimed at demonstrating the feasibility of, and developing methods for, incorporating individual genomic findings into clinical practice.

Building on the success of IGNITE I, the next phase of the network, IGNITE PTN (IGNITE II), began in 2018. This phase features five multi-site clinical groups and one coordinating center that conduct pragmatic clinical trials of genomic medicine interventions across diverse settings and populations. The Protocol Review Committee (PRC), convened by the NHGRI, chose two studies – ADOPT PGx and GUARDD-US – based on their clinical importance, feasibility, potential impact, and cost.

The Implementing GeNomics In pracTicE Pragmatic Trials Network (IGNITE PTN), also known as IGNITE II, is an NIH-funded network dedicated to supporting the implementation of genomics in healthcare. The network is comprised of five clinical groups that help promote the mission of IGNITE through support from a coordinating center, working groups (such as the Data and Safety Monitoring Board and Patient/Participant Advisory Board), affiliate members, and an external scientific panel.

ADOPT PGx

A Depression and Opioid Pragmatic Trial in Pharmacogenomics

Pain and depression are conditions that impact a substantial proportion of the U.S. population, but finding safe, effective drug therapies for both conditions is challenging. ADOPT PGx is a pragmatic clinical trial that enrolls patients into three pharmacogenomics (PGx)-guided therapy scenarios: acute post-surgical pain, chronic pain, and depression. For each scenario, participants will be randomized to genotype-guided drug therapy versus usual approaches to drug therapy selection ("usual care"). Changes in patient-reported outcomes representing pain and depression control using standard patient-reported outcomes measurement information system (PROMIS) scales define the primary endpoints. Secondary analyses include safety endpoints, changes in overall well-being, and economic impact represented by differences in healthcare utilization.

Timeline
February 2021 – May 2024

Design
All three arms are designed as prospective, multicenter, two-arm randomized pragmatic trials to evaluate the impact of pharmacogenetic testing and genotype-guided pain or antidepressant therapy on pain control or depression symptoms.

Intervention / Treatment
Pharmacogenetic Testing

Sponsor
National Human Genome Research Institute (NHGRI)

View More on ClinicalTrials.gov

GUARDD-US

Genetic Testing to Understand and Address Renal Disease Disparities across the U.S.

GUARDD-US is a pragmatic clinical trial that aims to determine the effect of returning Apolipoprotein L1 (APOL1) genetic risk information to hypertensive African ancestry participants and their primary care providers on systolic blood pressure (SBP). The primary outcome is the change in SBP from baseline to three months in participants with high-risk APOL1 variants (positives), comparing those who received results immediately versus those who received results at the end of the trial. APOL1-negative participants in the immediate arm were re-randomized to a genotype-guided approach to anti-hypertensive therapy versus usual care, and three-month SBP was compared between those with immediate return of PGx results and those with delayed return.

Timeline
July 2020 – May 2024

Design
Prospective, multicenter, unblinded, two-arm randomized pragmatic clinical trial. Randomized to immediate (intervention) vs. delayed (control) return of results for positive or negative APOL1 status.

Intervention / Treatment
Diagnostic Test: APOL1 status

Sponsor
National Human Genome Research Institute (NHGRI)

View More on ClinicalTrials.gov