National Resource Centers

The Cystic Fibrosis National Resource Centers provide study sponsors and investigators centralized expertise in outcome measures for CF clinical research. These centers also aim to advance new biomarkers and outcome measures that will be critical to our understanding of CF.

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Summary
  • There are two types of National Resource Centers (NRCs): NRC Outcome Measure Advancement Cores and NRC Clinical Service Cores.
  • Personnel at each NRC are available to consult with study sponsors and investigators about the use of specialized CF outcome measures and provide related support for specific studies (including for pre-clinical and translational research).

Specialized procedures are often needed to measure outcomes in CF clinical trials, including laboratory-based measurements, such as sweat chloride, microbiologic endpoints, and inflammatory markers; and interpretive outcomes, such as multiple breath washout/lung clearance index and nasal potential difference.

Currently there are two types of National Resource Centers (NRC):

  • NRC Outcome Measure Advancement Cores: These cores seek to develop and validate new outcome measures relevant to CF clinical research. Over time, outcome measures supported through this mechanism can mature into NRC Clinical Research Service awards. 
  • NRC Clinical Service Cores: These established core research services provide centralized and standardized assays/outcome measures relevant to CF clinical research.

Specialized Services

Personnel at each NRC are available to consult with study sponsors and investigators about the use of these specialized CF outcome measures and provide related support for specific studies (including for pre-clinical and translational research).

Services offered may include, but are not limited to:

  • Performance of central testing, interpretation, and/or data analysis
  • Assistance with selection of appropriate CF outcome measures
  • Consultation on outcome measure implementation
  • Assistance selecting and evaluating contract research organizations, both academic and commercial
  • Training, qualification, and ongoing support of study site operators

Contacting the NRCs early in the study development process can help make study setup more efficient and ensure more timely and cost-effective completion of studies.

For more information about specific services, contact the center personnel listed below.

NRC Outcome Measure Advancement Cores

Colorado NTM Outcome Measure Advancement Core NRC

This NRC consists of investigators and laboratories with unique skills and knowledge in studying nontuberculous mycobacteria (NTM). The goal of this core is to better understand NTM and to improve its diagnosis and treatment in CF. The NRC will advance innovative techniques and new technologies that bypass the current limitations of sputum cultures, which are insensitive and increasingly difficult to obtain. Services include consultation on preclinical NTM therapeutic development, provision of CF NTM isolates, in vitro testing of candidate antibiotics on well-characterized CF NTM isolates, novel models of NTM infection, analyses of NTM whole genome sequencing databases, protein structural modeling, quantitation of NTM in samples, phylogenetic analysis of NTM isolates, biomarker development,  pharmacokinetics/pharmacodynamics assays of sputum, and associated training of these techniques to qualified investigators and trainees.

Site: National Jewish Health, Denver

Director: 
Jerry Nick, MD
nickj@njhealth.org

Other personnel:
Charles Daley, MD, Professor of Medicine, National Jewish Health, Denver
daleyc@njhealth.org

Michael Strong, PhD, Associate Professor, National Jewish Health, Denver
strongm@njhealth.org

Rebecca M. Davidson, PhD, Assistant Professor, National Jewish Health, Denver
davidsonr@njJhealth.org

Cystic Fibrosis Microbiological Outcomes Advancement Core

This NRC develops and provides special and clinically relevant microbiological tests and resources for CF research and therapeutics development, including clinical specimens and microbial isolates, uncommon culture media and conditions, and molecular (DNA-based) microbiological identification and quantitation. This core will also serve as a repository of the specimens and isolates collected by CF studies; as a facility that can perform existing, nonstandard tests (such as sputum binding and in vitro susceptibility testing for new candidate treatments); and as a laboratory that develops new approaches and resources and performs new tests, such as DNA-based analyses.

Site: University of Washington, Seattle

Director: 
Lucas Hoffman, MD, PhD
lhoffm@uw.edu

Other personnel:
Donna Prybell, Core Administrator
dprybell@uw.edu

Stephen Salipante, MD, PhD, Sequencing Subcore Director
stevesal@uw.edu

Rafael Hernandez, MD, PhD, Clinical Isolate Subcore Director
rafael.hernandez@seattlechildrens.org

Nasal Cell Theratyping Advancement Core

The Cincinnati Children's Hospital Nasal Cell Culture Core for Outcome Measure Advancement focuses on optimizing and advancing laboratory models based on human nasal cells. The overarching goal of this core is to establish and validate a national system for collection and testing of human nasal epithelial cell-based models to support translational CF clinical care and research trials. This includes testing of cystic fibrosis transmembrane conductance regulator (CFTR) therapies (including modulators and nucleic acids) and other strategies to activate or inhibit ion transporters relevant to CF.

Site: Cincinnati Children's Hospital Medical Center

Director:
John Brewington, MD
john.brewington@cchmc.org

Other personnel:
Alicia Ostmann, Laboratory Manager
alicia.ostmann@cchmc.org

Rory O'Shaughnessy, MPH, Program Coordinator
rory.oshaughnessy@cchmc.org

Particle Tracking Micro-Rheology NRC

This NRC will work to validate the different methodologies used in particle tracking micro-rheology (PTMR) to determine the optimal experimental protocols for researchers to use to characterize CF mucus. They will further develop the training materials, tracking and analysis software, and back-end technical support to assist other groups in implementing PTMR as a biomarker of the mucus burden to CF patients. Goals of this NRC are to develop a standardized protocol for all labs to use to ensure consistent and comparable results between research groups and to assist other CF research groups in the implementation of this standard protocol for biophysical characterization of clinically relevant specimens onsite.

Site: The University of North Carolina at Chapel Hill

Director: 
David Hill, PhD
dbhill@med.unc.edu

Other personnel:
Matthew Markovetz, PhD, Research Associate
matthew_markovetz@med.unc.edu

NRC Core Clinical Research Services

Center for Biochemical Markers

The Center for Biochemical Markers provides expertise in the measurement of biomarkers of inflammation and injury (e.g., proteases, antiproteases, cytokines, oxidants) and measures of nutritional status (including vitamin and antioxidant levels) in blood, sputum, bronchoalveolar lavage fluid, stool, and urine specimens. This includes well-validated platforms and systems for performing multiplex assays.

Site: Children's Hospital Colorado and University of Colorado Anschutz Medical Campus

Director:
Scott D. Sagel, MD, PhD
scott.sagel@childrenscolorado.org

Other Personnel:
Rebecca Baldermann, Laboratory Manager
rebecca.baldermann@childrenscolorado.org
Phone: 720-777-8205

Center for CF Microbiology

The Center for CF Microbiology provides best-practice CF clinical laboratory microbiological services and consultation to develop and support CF clinical trials. The laboratory provides expertise in the isolation, quantitation, identification, and antibiotic-susceptibility testing of CF pathogens in respiratory tract samples. The center works to develop and validate laboratory methods, establish protocols for CF microbiology, and obtain high quality microbiology data for clinical trials.

Site: Seattle Children's Hospital

Director: 
Lucas Hoffman, MD, PhD, Laboratory Director
lhoffm@uw.edu

Other Personnel:
Anne Marie Buccat, MS, Technical Director
annemarie.buccat@seattlechildrens.org

Center for CFTR Detection

The Center for CFTR Detection specializes in the development and upkeep of harmonized standard operating procedures (SOPs), training, performance, and interpretation of nasal potential difference traces and other measures of CFTR detection in CF clinical trials. These include intestinal current measurements and lower airway potential difference measurements

Site: University of Alabama at Birmingham

Director:
George M. Solomon, M.D.
msolomon@uab.edu

Other Personnel:
Steven M. Rowe, MD, MSPH, Associate Director
smrowe@uab.edu

Heather Hathorne, PhD, Manager, Cystic Fibrosis Clinical Research Unit
hhathorne@peds.uab.edu

Center for Integrative Immunodiagnostic Cytology

This Core Laboratory for Integrative Immunodiagnostic Cytology provides expertise in quantitatively defining the CF patient inflammatory response, focusing on cells from the respiratory tract, including expectorated and induced sputum. The core provides support for the needs of the Therapeutics Development Network, industry sponsors, and CF clinical researchers with consultation services to enhance CF clinical research through experience in trial design, protocol design, outcome measure selection, safety measures selection, resource for training and data review as defined by study-specific needs. The core will also provide immunodiagnostic expertise through advanced analysis of specimens, better defining the cellular phenotype of CF inflammation.

Site: Case Western Reserve University

Directors:
Tracey Bonfield, PhD, D(ABMLI)
tracey.bonfield@case.edu

Kimberly McBennett, MD, PhD, FACP
kimberly.mcbennett@uhhospitals.org

Center for Sweat Analysis

The Center for Sweat Analysis offers expertise in the collection and analysis of sweat electrolytes, an outcome measure of CFTR protein function in CF clinical studies. Services and assays include training and certification in sweat collection, centralized analysis of sweat sodium and chloride, and consultative services to investigators interested in sweat electrolyte measurements.

Site: Children's Hospital Colorado and University of Colorado Anschutz Medical Campus

Director:
Edith Zemanick, MD, MSCS
edith.zemanick@childrenscolorado.org

Other Personnel:
Stacey Martiniano, MD, MSCS, Associate Director
stacey.martiniano@childrenscolorado.org

Elinor Towler, Database Manager
elinor.towler@childrenscolorado.org

Mary Cross, RRT, Research Coordinator
mary.cross@childrenscolorado.org

Colorado NTM Core Clinical Research Service NRC

The Colorado NTM Core Clinical Research Service NRC consists of investigators and laboratories with unique skills and knowledge in studying NTM. Their goal is to provide technical support to studies that aim to improve the diagnosis and treatment of NTM in CF. This NRC offers expertise in clinical study design, sample collection, specialized testing and banking of NTM, as well as a range of research tools that are needed to support and improve the success of clinical trials focused on this infection.

Site: National Jewish Health, Denver

Director:
Jerry Nick, MD
nickj@njhealth.org

Other personnel:
Charles Daley, MD, Professor of Medicine, National Jewish Health, Denver
daleyc@njhealth.org

Michael Strong, PhD, Associate Professor, National Jewish Health, Denver
strongm@njhealth.org

Rebecca M. Davidson, PhD, Assistant Professor, National Jewish Health, Denver
davidsonr@njhealth.org

Cystic Fibrosis Microbiome Analysis Core

The goal of the Cystic Fibrosis Microbiome Analysis Core is to facilitate best practices in microbiome research for the CF research community. The core has developed and will provide SOPs for all steps essential for microbiome analysis of CF clinical samples, including sample collection and processing, bioinformatics, and biostatistics. In addition, they will provide expert consulting and training in all phases of microbiome-based CF projects.

Site: Children's Hospital Colorado and University of Colorado School of Medicine

Director:
Jonathan Harris, PhD
jonathan.harris@cuanschutz.edu

Other personnel:
Dan Frank, PhD, Technical Consultant
daniel.frank@cuanschutz.edu

Charles Robertson, PhD, Bioinformatics Lead
charles.robertson@cuanschutz.edu

Brandie Wagner, PhD, Biostatistics Lead
brandie.wagner@cuanschutz.edu

Mucociliary Clearance NRC

This NRC supports the development and conduct of multicenter mucociliary clearance (MCC) studies by providing training and technological advances, disseminating expertise, and facilitating conduct of studies using the MCC endpoint.​ Service aims include elevating technical expertise and standardization and developing improved MCC study methodologies for dissemination to new sites​.

Site: The University of North Carolina at Chapel Hill

Director:
Scott Donaldson, MD
scott_donaldson@med.unc.edu

Other personnel:
William Bennett, PhD, Professor of Medicine, Co-Director of NRC
william_bennett@med.unc.edu

North American Multiple Breath Washout Center

The North American Multiple Breath Washout (MBW) Resource Center supports the development and upkeep of SOPs, training, and interpretation of MBW/lung clearance index testing in CF clinical research. The program is developing enhanced online learning materials to train more operators to correctly perform the MBW test, as well as computer software that can determine whether an MBW test is done properly. This will enhance the conduct of future CF trials and also potentially translate the use of this lung function test for routine monitoring of lung function.

Site: The Hospital for Sick Children

Director:
Felix Ratjen, MD, PhD
felix.ratjen@sickkids.ca

Other personnel:
Renee Jensen, Respiratory Therapist
renee.jensen@sickkids.ca

MBW center contact:
mbw.centre@sickkids.ca

Website:
https://lab.research.sickkids.ca/ratjen/mbw-centre/

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