The heart of the Urologic Oncology Branch is our clinical program- we study the human model of kidney cancer, prostate cancer and bladder cancer. The Urologic Oncology Clinical Core is comprised of a genetic counselor / protocol manager, clinical research nurses, patient care coordinators (PCC), a senior data manager and data managers. RESEARCH NURSES Clinical trials Research nurse specialists coordinate / manage the operations of our clinical trials in kidney cancer, prostate cancer and bladder cancer. Their responsibilities include: kidney cancer, prostate cancer and bladder cancer patient recruitment, participate in the informed consent process;perform patient education;create patient-specific protocol schedule;schedule blood and urine studies, CT scan, MRI;PET CT, internal medicine, neurosurgical, ENT consults;register patient with CRO;collect / review diaries with patients;assess patient compliance;rapid and accurate data capture;Q/A data entries in c3D;report AEs to NCI IRB and sponsor according to protocol requirements;submit annual Continuing Reviews to IRB;maintain regulatory binder;participate in clinical trial meetings. Familial Kidney Cancer A key component of the UOB Branch is the study of families who have rare inherited conditions, such as von Hippel-Lindau, Hereditary Papillary Renal Cell Cancer, Birt-Hogg-Dub Syndrome, and Hereditary Leiomyomatosis and Renal Cell Carcinoma, which predispose to development of kidney cancer. Research nurse specialists and a genetic counselor provide protocol oversight for our natural history protocols in kidney cancer, prostate cancer and bladder cancer. Responsibilities include: patient recruitment;telephone intake covering pedigree;initiation of informed consent process to include purpose of study;provide information about NIH, the study objectives, assess patients expectations;initial medical history;determine appropriate clinical studies;communicate with Patient Care Coordinators (PCC) re: appointment and indicated studies;assist PCC in obtaining pertinent medical records;tissue slides, films;obtain informed consent;assure patient has adequate understanding of information received during visit;prepare / submit annual Continuing Review to NCI IRB. Prostate Cancer and Bladder Cancer The prostate cancer and bladder cancer program is supported by research nurse specialists who have overall oversight of patients with localized prostate or bladder cancer. Responsibilities include: telephone intake to include;purpose of study;information about NIH, the study objectives, assess patients expectations;initial medical history;initiate informed consent process;determine appropriate clinical studies;communicate with Patient Care Coordinators (PCC) re: appointment and indicated studies;obtain informed consent in person;patient teaching;follow-up visit;assure Quality of Life questionnaires are submitted /received by patients at multiple time points;work with data managers to assure data is captured and submitted. GENETIC COUNSELING A Genetic Counselor actively participates in pursuit of the research questions about known genetic syndromes or unknown familial renal cancer. Responsibilities include: family recruitment through professional genetic societies;develop a 3-generation pedigree;complete a personal medical history;determine the genetic test to be performed;perform literature searches, contribute to the identification of novel clinical manifestations of rare heritable malignant disorders. Patients with or at risk for an inherited kidney cancer cancer susceptibility disorder undergo an extensive counseling / education session. Topics generally covered during these sessions include: Clinical aspects and natural history of the suspected disorder;if the disorder is unknown, the differential, clinical and genetic evaluation plan is presented;psychosocial risks of genetic testing;implications of potential genetic test results;clinical management of condition and /or multiple, bilateral renal tumors;health promotion strategies;provide supportive counseling at-risk or affected patients;provide written educational material and medical papers if appropriate;provide information about support groups;discuss familial communication. Genetic test results are provided per patient preferred modality;a counseling letter is sent with DNA result and recommended surveillance strategies. PROTOCOL MANAGER Overall protocol management is the responsibility of our Genetic Counselor. Protocol manager responsibilities include: draft natural history protocols;prepare and submit protocol amendments;submit Continuing Reviews for natural history and tissue procurement protocols;remain informed about the IRB process as well as the ethical / legal aspects of clinical research;serve as a resource/ mentor to the UOB about protocols and the IRB process PHYSICIANS ASSISTANT The in-patient and Urology consult service is managed by our Physician Assistant (P.A.). Responsibilities include: manage surgical patients upon decision for surgery;determine with surgical Fellows, the appropriate pre-operative work-up;arrange in-patient admission;schedule / enter orders for operative admission including imaging studies, consultations;refer patients to NIH social service for potential Family Lodge availability;perform H &P upon admission;conduct regular and frequent patient rounds;handle patient concerns while surgeons in operating room;schedule post-operative follow up visit;collaborate with nursing /social service re: discharge plan;see consult patient during post-op visit. The Urology consult service, offered to the entire NIH community is managed by our P.A. Responsibilities include: initially see / evaluate all consult patients;assess patient and, in concert with UOB Fellows, identify probable diagnosis;recommendations to referring service;see all consults at follow-up visits;submit consult note into CRIS system. PATIENT CARE COORDINATORS The complex task of scheduling multiple appointments and clinical studies is the responsibility of our patient care coordinators (PCC). PCC responsibilities include: schedule new and follow- up patient appointments;communicate with patients regarding reimbursement / travel policy;admission procedures;enter patient information into ATV system;schedule all studies such as CT, MRI. bone scan, PET CT;arrange coordinate consultations with internal medicine, neurology, endocrine, dermatology, cardiology consults, etc.;develop patient schedule;send letter of invitation;copy of protocol consent, appointment schedule;obtain relevant tissue slides, imaging studies and medical records;track / oversee recommendation by UOB physicians for follow-up visits and recommended studies for follow-up visits. DATA MANAGEMENT Senior Data Manager Overall management of UOB data is the responsibility of our senior Data Manager. His responsibilities include: adapt LabMatrix to UOB data needs;maintain extensive UOB database;responsible for data integrity;query requested reports;Q/A entered data;capture and track: demographics;tumor measurements;clinical manifestations;genetic test results / genotype;provide mentorship to contract data personnel. Data management staff: One data management staff is responsible for tracking/ identifying tumor size and location;growth rates of tumors;captures images for UOB archives. Two contract data staff members are responsible for entering / QA data collected from natural history and clinical trials;tracking enrollment;works closely with research nurses and CRO to assure data accuracy. All data from the clinical trials in entered into the LabMatrix database of the Urologic Oncology Branch.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Clinical Support Services Intramural Research (ZID)
Project #
1ZIDBC011089-06
Application #
8763806
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
6
Fiscal Year
2013
Total Cost
$1,312,223
Indirect Cost
Name
National Cancer Institute Division of Basic Sciences
Department
Type
DUNS #
City
State
Country
Zip Code
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