KMCRI-Supported Shared Resources
The Biostatistics/Informatics Shared Resource (BSR) has as its global objective to provide the infrastructure and expertise for centralized and project specific database development, management, and analysis. In addition, the BSR will ensure that all oncology and oncology-related researchers have ready access to consultation related to biostatistics/ informatics. The BSR will provide data entry, management and analytic support and aid in the design of experiments for oncology and oncology-related studies conducted by researchers affiliated with the Kansas Masonic Cancer Research Institute and the University of Kansas Medical Center. The specific aims are to:
1. Provide statistical and informatics expertise for investigators in:
a) Study/experimental design
b) protocol development
c) generating randomization codes
d) appropriate analysis of study/experimental data
2. Provide expertise in data management by:
a) storage of data for all basic science, clinical and behavioral studies
b) coordination of the preparing of data collection forms
c) development of a standardized reporting format across all studies conducted by investigators
d) database development
e) maintenance, monitoring, and management of study databases
f) development and maintenance a computerized data quality control system
3. Develop statistical methodology related to studies conducted by the Kansas Masonic Cancer Research Institute (KMCRI) investigators, to enhance study design, analysis, and interpretation of results.
4. Train investigators and their staff in data collection, quality assurance procedures, and statistical methodology.
5. Participate in the preparation of study presentations and publications.
The BSR faculty and staff have considerable experience and expertise and excellent facilities, which include up-to-date hardware and software provided by the Kansas Masonic Cancer Research Institute and the Department of Preventive Medicine. A Resource Advisory Group has been formed with expertise in oncology, biostatistics and informatics to advise the BSR on an ongoing basis.
Director: Matthew S. Mayo, PhD, mmayo@kumc.edu
Project Manager: Holly J. Smith, hsmtih@kumc.edu
The Biostatistics/Informatics Shared Resource website
The Biotechnology Support Facility (BSF), under the auspices of the Office of Research Administration, is housed in an 800 square foot laboratory centrally located at the University of Kansas Medical Center. The BSF provides automated DNA sequencing and oligonucleotide synthesis using an ABI Prism 377 DNA Sequencer and 394 DNA/RNA Synthesizer, respectively. For protein chemistry requirements, the BSF offers peptide synthesis utilizing a Rainin Quartet Multiple Peptide Synthesizer, amino acid analysis performed on a Hitachi L-8800 Amino Acid Analyzer, and protein/peptide sequencing conducted on an ABI 491 Protein Sequencer. The BSF oversees and operates the School of Medicine Microarray Core Facility, which provides gene expression analysis using the Affymetrix GeneChip Instrumentation System or Affymetrix 428 Array Scanner for custom glass slide microarrays. The Affymetrix GeneChip Instrumentation System includes an Agilent GeneArray Scanner, GeneChip Fluidics Station 400, and GeneChip Hybridization Oven 640. An Agilent 2100 Bioanalyzer provides rapid characterization of RNA preparations used in gene expression analyses. The Director of the facility is Dr. K. Michael Welch, MB, ChB, FRCP, Vice Chancellor for Research and President, KUMC Research Institute, Inc. The staff includes Bo Wisdom (bwisdom@kumc.edu), Lab Manager, Jim Rouse, Research Associate, and Clark Bloomer, Research Associate. The facility's website is http://www.kumc.edu/biochemistry/biotech.html
The Clinical Trials Office supports and facilitates investigators in the design, initiation and completion of clinical research of the highest quality that is dedicated to the prevention, treatment, and continuing of care related to cancer. Services provided include the following:
- Supports and coordinates research projects conducted by this university, research foundations, and businesses through research grants and cooperative agreements.
- Supports education and training in basic sciences and clinical disciplines for participation in basic and clinical research programs and treatment programs relating to cancer through contracts, grants (private and federal), and private funding.
Development Services
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Project development
- Protocol and CRF design
- Informed consent development/review
- Investigator qualification
- Internal monitoring to GCP/ICH standards
- Quality assurance
- Safety review of AEs
- Sensitivity to cultural and minority issues
Project Development
- Collection and processing of regulatory documents
- Study management documentation; includes:
- study guide (orientation guide for coordinators, Investigators, and personnel) - Protocol design
- CRF preparation
- Implementation meeting
Project Management
- Assist in accrual, consent, registration, and randomization of research subjects
- Accrual tracking
- CRF review
- AE review and reporting
- Quality Assurance
- Contract/Grant administration
- Advertising/ make available in KU Cancer Center and KMCRI website current listing of protocols, summaries, and current trial status
- Generate and send quarterly progress report to investigator
On-site monitoring
- Protocol compliance
- CRF accuracy and completeness; 25% audit against source, if more than 5% checked are incorrect, will conduct a 100% audit against source documents
- AE reporting
- Study progress
- Enrollment
- Eligibility of participants prior to enrollment
- Compliance of Investigator's document file
- Collection of data for interim analysis
- Assure that all CRFs and any queries are collected and complete
Data Management
- CRF design
- Database design/setup
- Education and training of investigators and study personnel on data collection and documentation
- Data entry
- Data validation/queries/resolutions
- Management of trial data system
- Generation of analysis database
Regulatory Affairs
- INDs
- Protocol review, including the KMCRI Protocol Review and Monitoring Committee(PRMC), Data Safety and Monitoring Board (DSMB) (if required)
- Protocol submissions and amendments to IRB
- Protocol submission and amendment approvals documented from IRB
- Annual Protocol re-certifications to IRB
- Informed consent approval from IRB
- Informed consent revisions and approvals documented from IRB
Director: Matthew S. Mayo, Ph.D. mmayo@kumc.edu;
Project Manager: Holly J. Smith, B.A. hsmith@kumc.edu
The Flow Cytometry Facility at the Kansas University Medical Center is dedicated to providing analysis of both patient and research specimens for the purpose of immunophenotypic type of analyses and DNA ploidy and cell cycle analyses. The facility is equipped with a Coulter XL flow cytometer powered by a Pentium III 500MHz system for both data acquisition and analysis. In addition, the facility has three workstations for post analysis requirements. The facility is staffed with three technicians. Two of the technicians are medical technologists specifically trained in analysis of patient samples as related to leukemias, lyphomas, bone marrow transplant progenitor cell enumeration, and CD4+ enumeration. The third technician is responsible for all research related aspects of analysis and all patient and research related DNA analysis. The instrument is capable of four color analysis and can analyze specimens as small as bacteria and chromosomes and as large as macrophage or larger fibroblast type cells. The facility can accommodate total sample preparation through and including data analysis or can receive investigator prepared specimens for data analysis only. The instrument is located within the Clinical Laboratories Department at the Bell Memorial Hospital. Dr. William Justice bjustice@kumc.edu
The Laboratory Animal Resources at the University of Kansas Medical Center is charged with the housing and care of research animals at the Medical Center campus. It is independent of the Lawrence campus facilities. Animals are maintained at two locations. The principal site is the Research Support Facility (RSF). The RSF contains 38,810 gross sq. ft. with 22,954 net assignable sq. ft. (animal rooms and support space). It has conventional rodent rooms, clean corridor rooms, rooms with HEPA filtration isolation cubicles, and a biohazard suite with interconnecting workspace. Other rooms are designed for larger laboratory animals. Construction on two additional floors to this facility is scheduled to begin in May or June 2000. The second animal facility occupies the fifth floor of the Mental Retardation Research Center (MRRC). The MRRC is a self-contained biomedical research operation including the animal facility that contains support spaces as well as conventional rooms for housing rodent species and monkeys. It contains 7,130 gross sq. ft. and provides 4,069 net assignable sq. ft. The total gross sq. ft. of animal housing and research support space included in this application is 45,940. A grant application for renovation of the MRRC facility is currently under development. The Director of Laboratory Animal Resources is responsible for management of the department including meeting all regulatory requirements and maintaining AAALAC accreditation. Departmental staff includes four veterinarians. Dr. David (DVM, MS) is board certified by the American College of Laboratory Animal Medicine and currently directs the department. Dr. Pinson (DVM, Ph.D.) is board certified by both the American College of Laboratory Animal Medicine and the American College of Veterinary Pathologists and currently serves as Associate Director. Dr. Pinson currently serves as interface to the Experimental Therapeutics Program. He has work experience in contract laboratories and Good Laboratory Practice regulations. Two graduate veterinarians function as supervisors. Staff includes administrative support personnel (3) and animal care technicians (approximately 16). Tony David, DVM, M.S., Director. David M. Pinson, DVM, Ph.D., Associate Director dpinson@kumc.edu
The Kansas Cancer Registry (KCR) collects and maintains information on the occurrence of cancer in Kansas, conducts cancer surveillance, monitors trends in treatment, and identifies sub-populations affected by different types of cancer. It is expected to have 12,421 Kansans diagnosed with invasive cancers annually. In order to conduct Kansas statewide cancer surveillance and identify these expected cancer cases, cancer registration has expanded to include the following: hospitals, pathology laboratories, free-standing radiation treatment centers, free-standing surgical centers, physicians, and data exchange with other states on Kansans who were diagnosed with cancer in their state. Currently, KCR has achieved over 91% completeness of cancer reporting within 12 months of the close of the diagnosis year and over 95% completeness of reporting within 24 months of the close of the diagnosis year. In addition to activities related to cancer surveillance, registry information can also be used by researchers to evaluate the effectiveness of new treatments and by public health professionals to implement and monitor prevention efforts (e.g. early detection). Dr. Sue Min Lai smlai@kumc.edu
The Tissue and Serum Repository Core Facility (TSR) provides a central facility and organized structure for the procurement of serum and tissue samples obtained from patients undergoing surgical procedures on the breast, ovary, endometrium, or uterus. Upon special investigator request, the TSR has obtained the approval to collect prostate, testicular, colon, liver, lung, and glioblastoma tissues. Consenting breast patients are asked to complete a health history questionnaire. The data requested include demographic, health and medical history, and lifestyle information. Specifically, questions concern age, racial/ethnic background, marital status, religion, weight, height, education, occupation, family income, family history of breast cancer, age at first period, menopause status, childbirth, lactation, and alcohol history. The TSR also offers pathological information to investigators. The overall objective of the TSR is to serve as a resource for investigators who need a comprehensive and well-documented storehouse of human tissue and corresponding serum samples. The goals of the TSR are to promote translational research activities in hormones and cancer, drug-interactions, and cellular membrane transporters involving basic and clinical scientists. Specimens from the Repository will be allocated primarily to researchers in Kansas, Missouri, and the Southern Great Plains States after proper institutional review of requests. Patient confidentiality is strictly maintained, and patients' identities are not available to users of the TSR Core Facility. Jodi Ballenger jballenger@kumc.edu
The Tissue and Serum Repository website
The Transgenic and Gene-targeting Institutional Facility (TGIF) provides a centralized service for production of transgenic and gene-targeted mice for researchers in KU and other regional institutions. Our mission is FIGT: Facilitate Innovations in Gene-targeting and Transgenesis. The facility is currently supported by the School of Medicine and Kansas Masonic Cancer Research Institute, and directed by Wenhao Xu, Ph.D.
The facility has two labs: one embryonic stem cell culture & manipulation lab, and one animal care lab. The facility is equipped with state-of-art instruments for making transgenic and knockout mice. A Nikon Diaphot 300 inverted microscope with HMC optic system and temperature-adjustable warming/cooling stage is mainly used for microinjection. A pair of Leitz micromanipulators, Stoelting microinjectors and a Eppendorf CellTram are used for either pronuclear or blastocyst injection. A de Fonbrune-type microforge and a Kopf vertical pipette puller are utilized for making holding and injection pipettes. A Bio-Cool controlled-rate freezer is available for cryopreserving embryos and gametes. A BTX square wave electroporator makes transfection of ES cells efficient. The embryonic stem cell lab has many other cell culture equipment.
The facility provides customer-oriented services to suit various needs in making transgenic and knockout mice. Investigators who are interested in expanding the role of transgenic technology in their research effort are encouraged to contact us. A requisition form for production of transgenic & knockout mice and other related services needs to be completed and submitted. The facility maintains a restricted fee account. Fees for each service are charged only for recovering material cost and equipment depreciation. For each construct accepted for microinjection, two microinjection time slots will be assigned in order to produce a minimum of two founders. Two progress reports will be sent to the investigators following the microinjection session; first at the birth of pups, and the second after weaning, tail samples from weaned pups will be provided for DNA analysis. The investigators will be expected to prepare analyzing tail DNA to identify founders within one week of receiving tail samples. Positive animals will be assigned to the investigator's research animal per diem charge at that time. Director: Wenhao Xu, Ph.D. wxu@kumc.edu