SABER Projects
AWARE: Autism With ADHD Research on Efficacy
Principal Investigator: Daniel Coury, MD
Sponsor: PCORI
The overall goal of the proposed study is to determine the relative effectiveness
of the most commonly prescribed FDA approved medications for the treatment of ADHD
in a specific population, children and adolescents with ASD. It is unclear whether
the guidelines previously developed for the treatment of ADHD in children with ASD
(largely based on guidelines for TD children) is appropriate or whether new guidelines,
specific to the ASD population, need to be developed. This naturalistic, pragmatic
clinical trial will use a multicenter SMART (Sequential Multiple Assignment Randomization
Trial) design to help resolve this controversy.
BASIC: The Brain Attack Surveillance in Corpus Christi Project
Principal Investigators: Lynda D. Lisabeth, PhD, MPH and Lewis B. Morgenstern, MD
Sponsor: National Institutes of Health (NIH)
The Brain Attack Surveillance in Corpus Christi (BASIC) project is an ongoing stroke
surveillance study that began in 1999. SABER began providing data management and programming
services to support this study in 2014. BASIC is the only ongoing stroke surveillance
project focusing on Mexican-Americans. Since the inception of this project, over 5,000
cerebrovascular disease patients have been followed.
BASIC: Cognitive
Principal Investigator: Lewis B. Morgenstern, MD
Sponsor: National Institutes of Health (NIH)
This study uses door-to-door surveillance in Nueces County, Texas, a non-immigrant,
bi-ethnic community, to determine the prevalence and trajectory over time of cognitive
impairment and dementia in Mexican-Americans and non-Hispanic whites. The study will
evaluate the roles of vascular disease risk factors, educational attainment and socio-economic
status, community resources, and caregiving roles to examine ethnic disparities. SABER
provides data management and programming for this study.
BASIC: Outcomes Among Surrogate Decision Makers In Stroke (OASIS)
Principal Investigators: Darin Zahuranec, MD and Lewis B. Morgenstern, MD
Sponsor: National Institutes of Health (NIH)
Often, people with stroke need help from another person to make decisions about important
medical treatments. However, we know very little about the experience and outcomes
of these family members who make medical decisions for a loved one with a stroke.
This study aims to answer important questions about how doctors communicate with family
decision-makers during these difficult times, how people make decisions for stroke
patients, and the long-term impact on those who serve as decision-makers for stroke
patients. SABER provides data management and programming for this study.
BASIC: Sleep Studies
Principal Investigators: Devin L. Brown, MD, MS and Lynda D. Lisabeth, PhD, MPH
Sponsor: National Institutes of Health (NIH)
The University of Michigan Stroke Program investigates multiple aspects of post-stroke
sleep apnea in patients in Corpus Christi, Texas. (1) An NHLBI-funded ancillary study
assessed the frequency of sleep-disordered breathing after stroke, and the relationship
of this sleep disorder to stroke outcomes. (2) The NINDS-funded sleep apnea study
is designed to investigate health disparities related to sleep apnea in stroke patients.
(3) An NHLBI-funded ancillary study investigates the association between nocturnal
rostral fluid shifts and sleep apnea severity. (4) Finally, an NINDS-funded longitudinal,
population-based study of sleep apnea and stroke outcomes is performed to improve
the identification and management of important sleep apnea after stroke, provide critical
data to plan future clinical trials, and explore a potential target to reduce an important
ethnic health disparity. SABER provides data management and programming for these
studies.
CAPTURE: Validating a Unique COPD Case Finding Tool in Primary Care
Principal Investigators: Fernando Martinez, Weill-Cornell and Meilan Han, University
of Michigan
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
CAPTURE is a large prospective study which explores the impact of the CAPTURE screening
tool for COPD on clinical care and patient outcomes across a broad range of primary
care settings in a cluster randomized controlled clinical trial. The study will enroll
approximately 5,000 patients across 100 participating primary care clinics associated
with practice-based research networks (PBRNs). Participants will be assessed with
the CAPTURE tool and have research spirometry testing. The tool will be compared against
the spirometry testing. In addition, participating primary care practices will be
randomized in a 1:1 fashion to receiving either a general COPD education module, or
a COPD module that includes training on the use of the CAPTURE tool, to assess the
12-month impact on patient outcomes.
ChiLDReN: The Childhood Liver Disease Research and Education Network
Principal Investigator: John Magee, MD
Sponsor: National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)
ChiLDReN is a network of 15 clinical sites conducting clinical trials and cohort studies
of children with rare liver diseases. The ChiLDReN Network was developed to support
the discovery of new diagnostics, etiologic, and treatment options for children with
liver disease, and those who undergo liver transplantation. SABER partners to provide
statistical analysis, clinical monitoring, project management, and clinical research
administration to support this series of studies.
Citalopram: Citalopram as a Posterior Cortical Protective Therapy in Parkinson’s Disease
Principal Investigator: Vikas Kotagal, MD, MS
Sponsor: National Institute of Aging (NIA)
Citalopram is a 5-year proof-of-concept Parkinson disease clinical trial aimed at
delaying visuospatial cognitive decline, a critical component of Parkinson disease
dementia. This is a single-site, phase 2, double-blind, and placebo-controlled study.
Participants with Parkinson disease will be enrolled in the study for 28-months, and
will receive either 20mg of citalopram daily, or matching placebo. They will undergo
PET and MRI imaging, as well as cognitive and clinical testing. SABER is the DCC
for this project and will provide project management, data management, software development,
and statistical analysis.
CRANE: Reducing falls with Varenicline in Hypocholinergic Parkinson Disease
Principal Investigators: Vikas Kotagal, MD, MS; Roger Albin, MD
Sponsor: NINDS
This early-phase single-site double-blind parallel group trial will randomize 76 participants with Parkinson disease-Mild Cognitive Impairment (PD-MCI) and evidence of low brain cholinergic integrity on brain fluoroethoxybenzovesamicol (FEOBV) Positron Emission Tomography (PET) to 12 months of either varenicline or placebo. The primary endpoint is change from the time of in-person screening to month 12 in “normal pace-dual task cost" (npDTC). Secondary and exploratory outcomes will examine varenicline’s effect on fall frequency, including a novel composite of falls, near-falls, and fall related injury. SABER is the DCC for this trial that provides project management, data management, and statistical analysis services.
CTR Launch: Comparing Protocol Writing Services with Protocol Writing Consultation
to Improve the Quality of Clinical Trial Protocol Documents
PI: Anna Lok, MD
Sponsor: National Center for the Advancement of Translational Science (NCATS)
This study is a single-center, randomized controlled investigation of two protocol
writing support services: protocol writing support (PPS) vs. protocol writing templates
and brief consultation (PTC) for University of Michigan study teams of single-site
investigator-initiated trials (IIT) of behavioral, drug, biologic, and device therapies.
Eligible IITs will be randomized 1:1 to either PPS or PTC, stratified by behavioral
vs. drug, biologic, or device trial therapies. The CTR-Launch study team and PI of
the randomized IIT and their study teams will be unblinded to study intervention;
however, the members of the Protocol Quality Rating Team will be blinded to study
strategy and trial PI. In addition, eligible IITs from PIs who do not agree to be
randomized will be assigned to a “no intervention, not randomized” (NINR) group and
receive neither PPS nor PTC. Protocol quality and other outcomes will be assessed
for these protocols.
DFC: Diabetic Foot Consortium Data Coordinating Center (DCC)
Principal Investigator for DCC: Cathie Spino, ScD
Sponsor: National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)
The Diabetic Foot Consortium (DFC) is a network of 4 clinical sites, 3 satellite sites, several biomarker analysis units, and the data coordinating center (DCC) that will conduct studies to validate biomarkers for diabetic foot ulcers. Future studies may expand to include clinical trials. SABER is the DCC for this consortium and provides the project management, data management, clinical monitoring, software development, and statistical reporting and analyses for the following consortium studies:
- C-myc Biomarker Study This is a multi-center observational cohort study of patients with diabetic foot
ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict
complete wound healing. Eligible and consented participants will begin standard of
care treatment after collection of tissue specimens from the wound’s edge. An additional
tissue specimen is collected at 4 weeks, if clinically indicated. Tissues will be
tested for multiple tissue biomarker levels using validated protocols at a central
laboratory. Participants will be followed weekly for up to 12 weeks or until complete
wound healing (whichever occurs first). One final assessment 2 weeks after complete
wound healing will occur to confirm healing.
- STATUS: In analysis with a sample size of 140 participant.
- TEWL Biomarker Study This is a multicenter study of patients with diabetic foot ulcers (DFU) to develop
and validate functional tissue biomarkers that predict DFU wound recurrence. Trans-epidermal
water loss (TEWL) will be measured on the closed wound site and a location similar
to the wound site (reference site). Participants will be enrolled within two weeks
after closure of their DFU. Complete wound healing will be verified at a second visit
two weeks later and this visit will start the 16-week timeline where participants
will be followed weekly by phone until the earliest of DFU wound recurrence or 16
weeks. Participants who experience a DFU wound recurrence and a subset of participants
who do not experience a DFU wound recurrence by week 16 will be asked to attend one
final visit.
- STATUS: In analysis with a sample size of 268 participants.
- Biorepository Study This is a multicenter study of patients with diabetic foot ulcers (DFU) to develop,
implement and organize a biorepository program for the collection of biosamples and
associated clinical data to inform and assist with future research endeavors. The
Biorepository will guide the DFC activities for collection and storing biosamples
and data from participants enrolled in current and future DFC studies. Participants
will be asked to enroll at the time of DFC protocol 001 (c-myc), DFC protocol 002
(TEWL) and future DFC approved protocol enrollment. Participants will be informed
of long-term archiving of biosamples in the NIDDK Central Repository (including de-identified
data in the data repository) prior to enrollment in the biorepository study.
- STATUS: Database closed on November 1st, 2024 . The study has been transitioned to Open DFC Master Protocol.
- Open DFU Master Protocol This study is a platform study designed to efficiently test multiple biomarkers
to identify diabetic foot ulcers (DFUs) with a higher potential for healing versus
not healing that ultimately could be applied at the point of care to drive personalized
management decisions, and to better inform clinical trials of wound healing interventions.
The platform study is designed to be flexible so that it is suitable for a wide range
of studies relevant to patients with open (active) DFUs. This platform study will
enroll patients with DFUs seen in an outpatient setting in diabetic foot and wound
care clinics across a range of healthcare systems, including community settings and
tertiary care hospitals, participating in the DFC. SABER is the DCC for this project
and will provide project management, data management, software development, and statistical
analysis.
- STATUS: First subject enrolled June 29th, 2023. In enrollment and follow-up.
DEPTH: Doxycycline for Emphysema in People Living with HIV
Study PIs: Robert Kaner, MD, Marshall Glesby, MD, and Cathie Spino, ScD
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
DEPTH (Doxycycline for Emphysema in People Living with HIV) is a phase 2, multicenter,
randomized, double-blinded, placebo-controlled clinical trial. Based on randomization,
participants will receive 100 mg doxycycline BID or placebo for 72 weeks. The primary
objective is to determine if doxycycline reduces progression of emphysema relative
to placebo as measured by rate of decline (slope) of present predicted diffusing capacity
for carbon monoxide (DLco) corrected for hemoglobin, carboxyhemoglobin, and barometric
pressure (indicated as ppDLcoadj) over the 72-week treatment period. SABER is the
DCC for this project and will provide project management, data management, clinical
monitoring, software development and statistical analysis for the clinical trial.
EGCG: Dose Ranging Study of Oral Epigallocatechin-3-Gallate (EGCG) Given Daily For
12 Weeks to Patients with Idiopathic Pulmonary Fibrosis (IPF) Evaluating Safety, PK
Interactions with Standard of Care Drugs, and Biomarkers of Drug Effect.
Principal Investigators: Harold A. Chapman, MD, Fernando J. Martinez, MD, MS, and
Cathie Spino, ScD
Sponsor: UCSF
The EGCG study is a multi-center, double-blind, placebo-controlled, dose-ranging phase
1 study looking at EGCG safety in idiopathic pulmonary fibrosis (IPF) patients. This
interventional study will test whether a low cost and largely non-toxic small molecule,
purified from green tea, EGCG, is safe when given daily to IPF patients over 12 weeks
with their IPF drugs, nintedanib and pirfenidone, and the pharmacokinetic interactions
of EGCG with these standard of care anti-fibrotic drugs. SABER is the DCC for this
project and will provide project management, data management, clinical monitoring,
software development, and statistical analysis for the clinical trial.
LYNC-LD: Lipodystrophy Syndromes to Determine Prevalence, Incidence and Predictors
of Diabetes and Severe Hypertriglyceridemia, and their Complications
Principal Investigator: Elif Oral, MD
Sponsor: Originally funded by Aegerion Pharmaceuticals. Now funded by Lipodystrophy
Research Fund established at the University of Michigan.
LYNC-LD is a prospective multicenter natural history study of lipodystrophy syndromes
to determine the prevalence, incidence and predictors of diabetes and severe hypertriglyceridemia,
and their complications. This is an international, multicenter, prospective registry
study of patients with lipodystrophies to define true prevalence estimates and document
a thorough snapshot of the natural history of lipodystrophies in the contemporary
era. Approximately 500 participants will be enrolled with all forms of lipodystrophy
syndromes. Their participation will last approximately 4 years while we collect robust
clinical, metabolic, morbidity, and mortality data. The primary aim is to determine
the natural history of common metabolic complications of lipodystrophy syndromes,
including diabetes mellitus and severe hypertriglyceridemia (fasting serum TG ≥ 500
mg/dL) in various subtypes of lipodystrophy syndromes, and to determine the incidence
rates of clinical outcomes related to these metabolic complications in participants
without these complications at baseline and describe the predictive value of their
baseline characteristics for the these clinical outcomes. SABER is the DCC for this
project and will provide project management, data management, and statistical analysis
for this clinical trial.
MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation
Principal Investigator: Riann Palmieri-Smith, PhD
Sponsor: National Institute of Child Health and Human Development (NICHD)
This study is a single-center, randomized, double-blind, placebo-controlled, and parallel-group
clinical trial to examine the combined efficacy of neuromuscular electrical stimulation
(NMES) and eccentric exercise (ECC) to promote the recovery of quadriceps strength,
improve physical and biomechanical function, and reduce the risk of post-traumatic
osteoarthritis (OA) after anterior cruciate ligament rehabilitation (ACLR).
MAP COPD: Michigan eArly disease Progression cohort in COPD
Investigators: MeiLan Han, MD, MS, Wassim Labaki, MD, MS, Jeffrey Curtis, MD, and
Craig Galban, PhD
Sponsors: Taubman Institute and COPD Foundation
Michigan eArly disease Progression cohort in COPD (MAP COPD) is an observational study
looking to gather new knowledge regarding screening for COPD and to understand the
burden of early COPD disease in patients. The aim of this study is to develop a disease
progression cohort within the University of Michigan Health System to capture pulmonary
function, symptom assessments and quantitative imaging among patients at risk for
or with an established diagnosis of COPD, focusing however on “early” COPD (age 30-60
and GOLD stage 0,1 and 2). Once the cohort is established, these data can subsequently
be used to (a) understand how to identify this patient population within a health
system and describe their symptom, exacerbation, radiologic and comorbidity burden;
(b) collect longitudinal information to understand disease trajectory in this unique
patient population; and (c) leverage this highly characterized patient pool for subsequent
therapeutic clinical trials. Ultimately, creation of this cohort at the University
of Michigan would establish a model that could be applied within other health systems
for establishing pools of well characterized, early-stage patients at risk for disease
progression to be leveraged for future studies.
PFF Community Registry
PI: Dr. Kevin R. Flaherty
Sponsor: Pulmonary Fibrosis Foundation
Pulmonary fibrosis (PF) results from a diverse group of health conditions and affects the lives of patients (including those who are post lung transplant), caregivers and family members. The Pulmonary Fibrosis Foundation Community Registry is an observational, longitudinal cohort study that offers an online portal where participants can self-enroll and directly contribute information about their experience with PF by answering a series of surveys at regular intervals to be compiled into a longitudinal data set for use by researchers. The PFF Community Registry enrolls three different cohort groups:
- Patients with PF, including those who are post lung transplant
- Caregivers of patients with PF
- Family members of patients with PF.
This is an online registry open to individuals affected by PF in the US. It is not associated with a physical location or institution
PFF-R: Pulmonary Fibrosis Foundation Registry and Biorepository
Principal Investigator: Cathie Spino, ScD
Sponsor: Pulmonary Fibrosis Foundation
The PFF-R is a prospective collection of data from over 2,000 patients with interstitial
lung disease, coming from over 40 Pulmonary Fibrosis Foundation Care Center Network
sites across the United States. Interstitial lung disease describes a diverse group
of conditions where, in general, the lung tissue becomes thickened, stiff, and scarred
(pulmonary fibrosis). These data are then made available to researchers to advance
our knowledge about this disease. SABER provides project and data management for this
study, and also provides statistical analyses, based on this collection of data, for
8-12 substudies per year which are proposed by interested researchers.
PRECISIONS: Prospective Treatment Efficacy in IPF Using Genotype for NAC Selection
Data Coordinating Center (DCC) Principal Investigators: Cathie Spino, ScD and Kevin
Flaherty, MD, University of Michigan
Clinical Coordinating Center (CCC) Principal Investigators: Fernando Martinez, MD,
Weill Cornell, and Imre Noth, MD, University of Virginia
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
PRECISIONS is a 6-year project which utilizes the Pulmonary Fibrosis Foundation Registry
and Biorepository (see separate entry on this page) to perform a whole genome sequencing
and proteomic analysis of around 1,400 people with interstitial lung disease. As
a proof of concept of how this data can be utilized to create a more precise approach
to medicine, the project includes a large double-blind, placebo-controlled, randomized
trial that will determine if people with idiopathic pulmonary fibrosis (IPF) who have
the TOLLIP rs3750920 TT genotype will benefit from the use of N-acetylcysteine (NAC)
in addition to standard of care for IPF. SABER is the DCC for this project and will
provide project management, data management, clinical monitoring, software development,
and statistical analysis for the clinical trial.
SUGARNSALT: Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes
and Diabetic Kidney Disease
Principal Investigators: Alessandro Doria, MD, PhD, MPH, Michael Mauer, MD, and David
Cherney, MD, PhD
Sponsor: Juvenile Diabetes Research Foundation (JDRF), Canadian Institute of Health
Research (CIHR), and Kidney Foundation of Canada (KFOC)
The goals of the SUGARNSALT trial are to evaluate the renal effectiveness of Sodium-Glucose
Transport Protein 2 (SGLT2) Inhibitors in Type 1 Diabetes (T1D) and to better understand
the benefit/risk ratio of sotagliflozin (SOTA) in T1D persons with moderate to advanced
diabetic kidney disease (DKD). The study is a multi-center, double-blind, placebo-controlled,
parallel-group randomized clinical trial in 150 patients with T1D and moderate to
advanced DKD. The eGFR at the end of the wash-out adjusted by its baseline value will
be used as the primary outcome on which SOTA efficacy on DKD progression will be evaluated.
SABER is the DCC for this clinical trial and will provide project management, clinical
monitoring, data management, software development, and statistical analysis.
THRIVE: Trajectories of Recovery After Intravenous Propofol vs Inhaled Volatile Anesthesia
Trial
Principal Investigators: Michael Avidan, MBBCH, FCASA and Sachin Kheterpal, MD, MBA
Sponsor: Patient-Centered Outcomes Research Institute (PCORI)
The THRIVE study is a multicenter randomized trial, with randomization to either propofol TIVA or inhaled volatile general anesthesia (INVA) for patients who are undergoing elective non-cardiac surgery. Patients will be allocated to one of the two trial arms using minimization. The primary aims of this trial are to determine whether patients undergoing (a) major inpatient surgery, (b) minor inpatient surgery, or (c) outpatient surgery have a superior quality of recovery after INVA or TIVA and whether TIVA confers no more than a small (0.2%) increased risk of definite intraoperative awareness than INVA. SABER provides study design and oversight, enrollment reporting, statistical analysis, data collection infrastructure, informatics pipelines, and participant interaction for this study.
TOPMed: Trans-Omics for Precision Medicine
Principal Investigator: Goncalo Abecasis, PhD
Sponsor: National Heart, Lung and Blood Institute (NHLBI)
The TOPMed Informatics Research Center (IRC) at the University of Michigan provides
advice to participating studies, sequencing centers and staff at the National Institutes
of Health on the handling, processing and interpretation of large-scale sequence data.
The IRC will jointly analyze sequence data and aid study investigators with informatics
challenges, particularly for cross study analyses. A key goal of the Informatics Research
Center is to make study results easily accessible to a broad range of scientists.
SABER is responsible for assisting the IRC with obtaining and managing any missing
and/or needed data files (i.e. subject consent, subject sample mapping, sample attributes,
pedigree and phenotype) for dbGaP upload and submission for curator review. Additional
support includes preview and approval of dbGaP submissions prior to release to the
public as well as uploading of omics data (RNA sequencing, DNA methylation and metabolomics)
via the dbGaP submission portal.
3D Splint: A Multi-Center Trial to Assess the Safety and Effectiveness of a Bioresorbable
Tracheobronchial Splint in Pediatric Subjects with Clinically Significant Tracheobronchomalacia
Principal Investigator: Richard Ohye, MD
Sponsor: University of Michigan
This device trial seeks to demonstrate the safety and effectiveness of the Materialise
Bioresorbable Tracheobronchial splint device in 35 pediatric patients (greater than
1 week and less than 4 years of age) with clinically significant tracheobronchomalacia
(TBM). TBM is a condition of dynamic collapse of the trachea or bronchi during respiration,
and leads to a wide array of respiratory symptoms, which can range from a chronic
cough and/or wheezing with vigorous activity to life-threatening airway obstruction.
Currently, the most severe forms of TBM lack adequate intervention. The Bioresorbable
Tracheobronchial Splint was originally developed at the University of Michigan, and
in December 2015, the airway splint Intellectual Property was licensed to Materialise;
Materialise has since taken over further development of the device. The primary endpoints
of the study are short-term patency (4+/-2 weeks post splint implantation) as measured
by CT scan and safety/survival to six months post-splinting. SABER provides project
management, clinical monitoring, and data management for this study.
Udall: The University of Michigan Udall Center of Excellence for Parkinson's Disease
Research
Principal Investigators: Roger Albin, MD
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Up to 70% of patients with Parkinson's disease fall each year, quadrupling the rate
of hip fractures, leading to extended hospitalizations, increased use of skilled nursing
facilities and eventual nursing home placement. UM scientists have developed breakthrough
evidence that these falls, which are resistant to currently available treatments,
arise from the degeneration of brain cells that use the neurochemical acetylcholine.
By integrating neuroimaging, behavioral and pharmacological studies in patients with
Parkinson's disease and in animal models, we aim to further dissect the relationship
between falls and abnormalities in these brain cells, and to develop the data necessary
to launch a clinical trial of a novel treatment for these debilitating symptoms of
Parkinson's disease. SABER acts as the biostatistics and data management center for
this series of studies.