Current Clinical Research Trials
Precision for Medicine/ Clinical Biospecimen Collection To Support Biomarker Research
PFM064
Principal Investigator: Rod Flynn, MD
This study involves collecting biospecimens (such as cells, tissue, blood, fluids. etc.) from patients with suspected or confirmed diseases-state, as well as healthy individuals. The biospecimens will be used for biobanking and commercial purposes, including the development of biomarkers, technologies, and other treatments. Participants will consent to share their samples with medical researchers working on improving disease detection and treatment methods.
Collection of Blood, Urine and Tissue Samples from Patients with Solid Malignant Tumors.
Principal Investigator: Jeffery Pelton, MD
Purpose of the study is to collect biological samples from the blood, urine and/or tissue from donors with cancer. The samples from the collection will perform biological research on blood and/or tissue from donors. The objective of the research is to gain insight into the biology of various diseases with respect to diagnosis, biomarkers, new treatment, and side effects of treatment. The sponsor will store the samples for future biological research. In addition, the sample may assist in the development of a new drug treatment or a new diagnostic test.
Physician Initiated Studies
Efficacy Of Localizing Imaging In The Management Of Primary Hyperparathyroidism
Principal Investigator: Jeffrey Pelton, MD
This protocol will develop a database for primary hyperparathyroidism patients treated at Mary Washington Hospital. The database will include clinical details, pathology details, and results of all preoperative localization studies. The information in the database would include the currently treated 40 patients and would then be collected prospectively on all future patients. This information can be used in future retrospective studies in determining the accuracy of each of these preoperative localization studies and can be used in correlating these results with operative success and clinical outcomes. The study can also be used in a cost/benefit analysis of the application of these imaging studies in the preoperative localization of this disease.
Meldb_ Development of a Prospective Database for Surgically Resectable Melanoma Patients With Gene Expression Profile Testing.
Principal Investigator: Jeffrey Pelton, MD
This study will develop a prospective digital database regarding information on all patients with Stage I-III cutaneous melanoma (henceforth referred to as “Melanoma Database”). The database will include clinical details, pathology details, and Gene Expression Profile (GEP) results. The information in the database would be collected prospectively and would be used in future retrospective studies in correlating GEP results, and other clinical and pathologic details, with patient overall survival, recurrence rates and recurrence-free survival. Retrospective review of the database could also be used to examine what types of treatments patients received and patient outcomes after those treatments, especially correlated to GEP results.
Previous Clinical Trials
Observational Cohort Study of Cabenuva Utilization, Outcomes and Patient Experience in the United States (Beyond)
Sponsor: ViiV Healthcare
Principal Investigator: Norman Bernstein, MD
The BEYOND study is a prospective, observational, multisite cohort study of adult participants initiating treatment with Cabenuva (cabotegravir long-acting plus rilpivirine long-acting) in the US. The purpose of the BEYOND study is to better understand reasons why participants and clinicians have chosen to initiate Cabenuva, participants' reasons for switching to Cabenuva, their experience and satisfaction with Cabenuva, their medical history, and their quality of life.
Integrated Care Repository for Cancer Research (iCaRe2)
Sponsor: University of Nebraska Medical Center
Principal Investigator for Breast Registry: Darlene K. Blanchard, MD
Principal Investigator for Thoracic Registry: J. Timothy Sherwood, MD
XIENCE 28 USA - ABT-CIP
https://clinicaltrials.gov/ct2/show/NCT03815175?term=xience+28&cntry=US&draw=2&rank=1
Sponsor: Abbott
Principal Investigator: Harish Chandra, MD
Sub Investigators Thomas Martyak, MD, Prithvi Rai, MD
Xience 90: A Safety Evaluation of 3-Month Dapt After Xience Implantation for High Bleeding Risk (Hbr) Patients.
https://www.clinicaltrials.gov/ct2/show/NCT03218787?term=xience+90&rank=1
Sponsor: Abbott
Principal Investigator: Harish Chandra, MD
Sub Investigators: Thomas Martyak, MD, Zeshan Rana, MD
OPTISURE: Optisure Lead Study
https://www.clinicaltrials.gov/ct2/show/record/NCT02235545?term=optisure&rank=1
Sponsor: Abbott
Principal Investigator: Ashok Talreja, MD
Sub Investigator: Henry Clemo, MD
Oncocyte Lung: A Study to Evaluate a Panel of Blood Biomarkers for use in Patients undergoing Evaluation for Lung Cancer, ONC-LN-04
Sponsor: OncoCyte Corporation
Principal Investigator: J. Timothy Sherwood, MD
BMS-001: A Multicenter Registry Study of Breast Microseed Treatment for Early-Stage Breast Cancer; Breast Microseed Registry
http://www.breastmicroseed.com/
https://www.clinicaltrials.gov/ct2/show/NCT02701244?term=concure&rank=1
Sponsor: Breast Microseed, Inc.
Principal Investigator: John Chinault, MD
Emperial Trial 1245-0167: A Phase III Randomised, Double-Blind Trial to Evaluate the Effect of 12 Weeks Treatment of Once Daily Empagliflozin 10 MG Compared With Placebo on Exercise Ability and Heart Failure Symptoms, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (Hfref) (Emperial-Reduced)
https://www.clinicaltrials.gov/ct2/show/NCT03448419?term=Emperial+trial&rank=1
Emperial Trial 1245-0168: A Phase III Randomised, Double-Blind Trial to Evaluate the Effect of 12 Weeks Treatment of Once Daily Empagliflozin 10 MG Compared With Placebo on Exercise Ability and Heart Failure Symptoms, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (Hfref) (Emperial-Reduced)
https://www.clinicaltrials.gov/ct2/show/NCT03448406?term=Emperial+trial&rank=2
Sponsor: Boehringer Ingelheim Pharmaceuticals, Inc.,
Principal Investigator: Anita Banerjee, MD
Sub Investigator: Anh Vu, MD
GLORIA - AF: Global Registry on Long-Term Oral Anti-Thrombotic TReatment In PAtients with Atrial Fibrillation (Phase II/III)
https://clinicaltrials.gov/ct2/show/NCT01468701?term=GLORIA&recrs=e&draw=2&rank=3
Sponsor: Boehringer Ingelheim Pharmaceuticals, Inc.,
Principal Investigator: Robert Vranian, MD
READY 1: A Phase 3, Randomized, Double-Blind, Active and Placebo-Controlled Study on the Use of CUSA-081 For Dysfunctional Central Venous Access Devices (CVAD’s)
https://clinicaltrials.gov/ct2/show/NCT03594175?term=READY+1&draw=2&rank=1
Sponsor: Chiesi Farmaceutici S.p.A
Principal Investigator: Gustavo Elias, MD
Sub Investigator: Sam Hijaz, MD
Mtg-022 Translational Medicine: Discovery and Evaluation of Biomarkers/Pharmacogenomics for the Diagnosis and Personalized Management of Patients. Under the Mtg-022 Master Protocol Are the Following Sop Studies: Mt1410-A, mt9920, mt1822-a and Mt1822-B.
Sponsor: The MT Group
Principal Investigator: Jeffery Pelton, MD, J. Timothy Sherwood, MD