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Active Studies at High Point Regional Health

The following research studies are currently in progress at High Point Regional Health.  Many studies are open to new participants.  Others have completed their enrollment period as noted and are not accepting new participants.  If you are interested in participating in a research study, please ask your physician to assess your eligibility.

 More information about these studies can be found on the ClinicalTrials.gov website, run by the U.S. National Institutes of Health.  ClinicalTrials.gov is a registry of clinical studies of human participants conducted around the world.

Cardiology
Cardiovascular Surgery
Eye Care
Infection Control
Neurology
Oncology
Orthopedics


Cardiology

 Title  ACRIN 4701 – RESCUE: Randomized Evaluation of Patients With Stable Angina Comparing Utilization of Diagnostic Examinations
 Summary   Summary: This randomized, controlled, diagnostic, multicenter trial will compare two diagnostic imaging pathways--coronary computed tomography angiography (CCTA) and single photon emission tomography (SPECT) myocardial perfusion imaging (MPI)--to determine the incidence of major adverse coronary events (MACE), defined as myocardial infarction (MI) or cardiac-related death, and cross-over to revascularization. CCTA may be used to direct patients with symptoms of stable angina or angina equivalent to optimal medical therapy (OMT). The use of CCTA as a diagnostic tool for angina symptoms will be associated with no increase in MACE or revascularization, decreased cost, reduced risks (e.g., less radiation exposure), additional insights into alternate explanations of chest pain, and increased cost-effectiveness in comparison with use of SPECT MPI/invasive coronary angiography (ICA).  Enrollment complete.
   
 Title  BIOFLEX-I – The Treatment of Iliac and Femoral Atherosclerotic Lesions Using the Self-expanding Astron and Pulsar Stents
 Summary  The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.  Enrollment into iliac arm complete.
   
Title BIOHELIX-II – The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent
 Summary  The purpose of this study is to assess the clinical performance of the BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries.
   
  Title IMPROVE-IT – A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - IMPROVE IT)
 Summary  This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. As per the original protocol, if low-density lipoprotein cholesterol (LDL-C) response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped). Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of CV death, major coronary events, and stroke.  Enrollment complete.
   
 Title COMMANDER HF - A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Oral Rivaroxaban with Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects with Chronic Heart Failure and Significant Coronary Artery Disease Following a Hospitalization for Exacerbation of Heart Failure
 Summary  This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, eventdriven, superiority study of rivaroxaban with clinical outcome assessments in subjects with chronic symptomatic HF (3 months or longer) and significant CAD. The subject population comprises men and women age 18 and over who have a diagnosis of previous MI or significant CAD with a left ventricular (LV) dysfunction (left ventricular ejection fraction [LVEFJ) S40%). Only subjects hospitalized for decompensated HF (known as the index hospitalization) will be eligible for enrollment at hospital discharge (and up to 7 days after discharge) if they are in stable condition.
 
   
 Title REGULATE-PCI – A Randomized, Open-Label, Multi-Center, Active-Controlled, Parallel Group Study To Determine the Efficacy and Safety of the REG1 Anticoagulation System Compared to Bivalirudin in Patients Undergoing Percutaneous Coronary Intervention
 Summary This study is designed to determine the efficacy of REG1 compared to bivalirudin in preventing periprocedural ischemic complications and major bleeding in patients undergoing PCI as a treatment for CAD. Bivalirudin has been studied in patients undergoing PCI in both ACS (NSTEMI and unstable angina [UA]) and elective PCI. In comparison to UFH, bivalirudin has shown similar rates of ischemic events while demonstrating a significant reduction in bleeding and an improved net clinical benefit.
Evidence from previous studies indicates that pegnivacogin represents an extremely potent, chemically unique anticoagulant that can be reversed by anivamersen across multiple populations. The question that still remains is whether Factor IX (FIX) inhibition by pegnivacogin can result in fewer ischemic events than a previously studied agent while active control with anivamersen can preserve the benefit of reduced bleeding. The purpose of this study is to evaluate REG1 in an adequately powered definitive study with an open-label, multi-center, active-controlled, randomized design to answer that question.
   
 Title  Ultra-Early Hospital Discharge after STEMI for Low-Risk Patients Application of the HPRHS-CCC Risk Protocol
 Summary  The purpose of this study is to evaluate the safety and effectiveness of earlier than usual discharge from the hospital in a group of real-world patients with low-risk of problems who have experienced a type of heart attack, known as ST elevated myocardial infarction.
Title CANOPY – Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
 Summary   The objective of the CANOPY trial is to assess the continued safety and effectiveness of the RX Acculink Carotid Stent System under commercial use in subjects at standard risk for adverse events from Carotid Endarterectomy (CEA) enrolled by physicians with a range of carotid stenting experience.


Eye Care

Title  Alcon C-11-20 – Post Approval Study of the AcrySof® IQ Toric Intraocular Lens (IOL) Models SN6AT6-SN6AT9
 Summary   The purpose of this study is to evaluate the use of toric high cylinder power intraocular lenses in a larger population in clinical practice and assure the continued safety of these approved devices.


Infection Control

Title EPICENTER – A Four-arm Prospective, Multicenter Study to Assess the Efficacy, Effectiveness, and Feasibility of Enhanced Terminal Room Disinfection With Chlorine and UV Light Using Clinical and Microbiologic Outcomes
 Summary   Enhanced terminal room disinfection is a novel, promising, but still unproven strategy for the prevention of healthcare-associated infections (HAIs) due to selected multidrug-resistant (MDR) bacterial pathogens. The investigators will perform a large prospective, multicenter study enhanced terminal room disinfection to 1) determine the efficacy and feasibility of enhanced terminal room disinfection strategies to prevent HAIs and 2) determine the impact of environmental contamination on acquisition of MDR-pathogens among hospitalized patients.


Neurology

Title  Accera PET – A single-site, fludeoxyglucose positron emission tomography (FDG-PET) study of AC-1202, (Axona®), treated participants with mild-to-moderate Alzheimer's disease (AD)
 Summary  The purpose of this study is to see whether increasing ketone bodies in the blood, by drinking Axona which has special fats in it, will improve scores on memory tests and change the amount of glucose used by the brain in a PET scan.


Oncology

Title MEAL Study – The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance
 Summary  RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer.
PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.
   
 Title Juice Plus – A Phase II Randomized Placebo Controlled, Double Blinded Trial To Evaluate The Effects Of Fruit And Vegetable Extracts On Intermediate Biomarkers In Head And Neck Cancer Patients
 Summary RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. Fruit and vegetable extracts may be effective in preventing the recurrence or further development of head and neck cancer.
PURPOSE: This randomized phase II trial is studying how well fruit and vegetable extracts work in preventing the recurrence of stage I, stage II, stage III, stage IVA, or stage IVB head and neck cancer.  Enrollment complete.
   
Title LCCC 1218 - A Multicenter Study to Evaluate Cardiovascular Risk Factors and Receipt of Primary and Preventive Care in Prostate Cancer Patients who Receive Definitive Radiation Therapy and Androgen Deprivation Therapy
 Summary The purpose of this study is to learn about the types of primary care that men treated with radiation treatment for prostate cancer receive and the influence of this care on their health, especially their cardiovascular health.  This research study also aims to learn about men's experiences during treatment, their satisfaction with their care, and the influence of treatment on their quality of life.  The results of this study will help to improve the care and health of men who have been treated for prostate cancer.
   
  Title A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer
 Summary This study is looking at whether Metformin, an agent that is commonly used to treat diabetes, can decrease or affect the ability of breast cancer cells to grow and whether Metformin will work with other therapies to keep cancer from recurring. Health Canada has not approved the sale or use of Metformin to treat breast cancer, although they have approved its use in this clinical trial. Although Metformin is approved by the FDA for the treatment of diabetes, its use in breast cancer is considered investigational.  Enrollment complete.
   
 Title Biobehavioral Mechanisms of Fatigue in Patients Treated on NCIC CTG MA.32: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer
 Summary RATIONALE: Studying samples of blood in the laboratory from patients with breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to fatigue.
PURPOSE: This research study is studying biomarkers associated with fatigue in patients with early-stage breast cancer treated with metformin or placebo on NCIC-CTG-MA.32.  Enrollment complete.
   
 Title A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women With Stage 0, I, or II Breast Cancer
 Summary RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill any tumor cells that remain after surgery. It is not yet known whether whole breast radiation therapy is more effective than partial breast radiation therapy in treating breast cancer.
PURPOSE: This randomized phase III trial is studying whole breast radiation therapy to see how well it works compared to partial breast radiation therapy in treating women who have undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.  Enrollment complete.
   
 Title  A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
 Summary RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.  Enrollment complete.
   
 Title A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently With Radiation Therapy and Radiation Therapy Alone for Women With HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy
 Summary This randomized phase III trial is studying radiation therapy to see how well it works compared with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma in situ.
   
 Title A Phase III Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
 Summary The main purpose of this study is to learn if adding bevacizumab to standard treatment with chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) for early stage HER2-negative breast cancer will prevent breast cancer from returning. A second purpose of this study is to learn if adding bevacizumab to treatment with chemotherapy will help women with HER2-negative breast cancer live longer. The researchers also want to learn about the side effects of the combination of drugs used in this study.  Enrollment complete.
   
 Title NSABP Patient Registry and Biospecimen Profiling Repository
 Summary This is a study to collect and analyze tissue specimens from metastatic colorectal cancer (mCRC) patients for the development of a molecularly profiled tissue repository for the primary purpose of maintaining a patient registry for future clinical trials based on the molecular profile of the tumors. The main purpose of testing these tissue specimens is to identify genetic alterations or biomarkers associated with colorectal cancer such that if new agent(s) become available, particularly those that target these genetic alterations/biomarkers, participants may be offered the opportunity to take part in a National Surgical Adjuvant Breast and Bowel Project (NSABP) treatment protocol.
   
 Title Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial
 Summary This randomized phase III trial is trying to find out the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.  Enrollment complete.
   
Title  A Phase III Protocol of Androgen Suppression (AS) and 3DCTR/IMRT vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer
Summary RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving hormone therapy and radiation therapy together with chemotherapy is more effective than giving hormone therapy together with radiation therapy in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer.  Enrollment complete.
   
Title Phase II Randomized Trial of Prophylactic Manuka Honey for the Reduction of Chemoradiation Therapy Induced Esophagitis-Related Pain During the Treatment of Lung Cancer
Summary RATIONALE: Manuka honey may prevent or reduce esophagitis-related pain caused by chemotherapy and radiation therapy. It is not yet known whether Manuka honey is more effective than standard care in preventing pain.
PURPOSE: This randomized phase II clinical trial is studying Manuka honey to see how well it works in preventing esophagitis-related pain in patients receiving chemotherapy and radiation therapy for lung cancer.
   
Title SWOG 0307 – Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
 Summary RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer.
PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.  Enrollment complete.
   
Title SWOG 0424 – Molecular Epidemiology Case-Series Study of Non-Small Cell Lung Cancer in Smoking and Non-Smoking Women and Men
Summary  RATIONALE: Studying samples of blood and tissue from smokers (closed to entry as of 7/15/07) and non-smokers with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about risk factors for lung cancer and may help the study of cancer in the future.
PURPOSE: This clinical trial is studying carcinogens in lung tissue from smokers (closed to entry as of 7/15/07) and non-smokers with newly diagnosed stage I, stage II, or stage III non-small cell lung cancer.  Enrollment complete.
   
Title SWOG 0715 – Randomized Placebo-Controlled Trial of Acetyl-L-Carnitine (ALC) for the Prevention of Taxane Induced Neuropathy Phase III
Summary RATIONALE: Acetyl-L-carnitine may prevent or lessen neuropathy caused by chemotherapy. It is not yet known whether acetyl-L-carnitine is more effective than a placebo in preventing neuropathy caused by chemotherapy.
PURPOSE: This randomized phase III trial is studying acetyl-L-carnitine to see how well it works compared with a placebo in preventing neuropathy in women with stage I, stage II, or stage III breast cancer undergoing chemotherapy.  Enrollment complete.
   
Title SWOG 1007 – A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. (The Rx PONDER Trial)
Summary This phase III clinical trial is studying how well giving tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy works in treating patients with invasive breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer.
   
Title SWOG 1013 – A Prospective Study of Epidermal Growth Factor Receptor (HER-1/EGFR) Inhibitor-Induced Dermatologic Toxicity: Validation of the Functional Assessment of Cancer Therapy-EGFRI 18(FACT-EGFRI 18) Questionnaire for EGFRI-Induced Skin Toxicities 
Summary RATIONALE: Questionnaires that patients can use to assess skin toxicities related to treatment may help identify the intermediate-and long-term effects of cetuximab, panitumumab, or erlotinib hydrochloride.
PURPOSE: This trial studies the validation of a cancer questionnaire for skin toxicities in patients with colorectal or lung cancer receiving cetuximab, panitumumab, or erlotinib hydrochloride.
   


Oncology - Cornerstone Hematology/Oncology 

Title  A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas – GS-US-313-0124 
Summary The purpose of this study is to evaluate the effect of idelalisib (GS-1101) on the onset, magnitude, and duration of tumor control. 
   
Title  A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Bendamustin and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas – GS-US-313-0125
Summary The purpose of this study is to evaluate the effect of idelalisib (GS-1101) on the onset, magnitude, and duration of tumor control. 
   
Title  A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Long-Term Safety and Efficacy of Darbepoetin Alfa Administered at 500 ug Once-Every-3-Weeks in Anemic Subjects with Advanced Stage Non-small Cell Lung Cancer Receiving Multicycle Chemotherapy – Amgen 20070782 
Summary  This is a double-blind, randomized, placebo-controlled phase 3 non-inferiority study in subjects with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV Non-Small Cell Lung Cancer (NSCLC). Approximately 3000 subjects with stage IV NSCLC expecting to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy will be enrolled into the study.  Subjects will be randomized in a 2:1 allocation (Group A: darbepoetin alfa 500 ug every 3 weeks <Q3W>, Group B: placebo Q3W) 
   
Title An Open-label, Multicenter, Randomized Phase 2 Study of a Recombinant Human Anti-VEGFR-2 Monoclonal Antibody, IMC-1121B in Combination with Platinum-based Chemotherapy versus Platinum-based Chemotherapy Alone as First-line Treatment of Patients with Recurrent or Advanced Non-small Cell Lung Cancer (NSCLC) – ImClone IMCL CP12-0917 
Summary  The purpose of this study is to determine if patients with Stage 4 non-small cell lung cancer have a better outcome when treated with 1121B in combination with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin than when treated with pemetrexed + carboplatin/cisplatin or gemicitabine + carboplatin/cisplatin alone. 
   
Title  A Randomized, Double-Blind, Multicenter Study of Denosumab Compared with Zoledronic Acid (Zometa) in the Treatment of Bone Disease in Subjects with Newly Diagnosed Multiple Myeloma – Amgen 20090482 
Summary  The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma. 
   
Title  The Multiple Myeloma Disease Registry 
Summary  The purpose of the MM Registry is to explore the natural history and real world management of patients with newly diagnosed symptomatic multiple myeloma (MM) and provide unique insights into the management of MM and the impact of this hematological disorder on patients. 
   
Title  MAVERICC – A Randomized Phase II Study of Bevacizumab/mFOLFOX6 vs. Bevacizumab/Folfiri with Biomarker Stratification in Patients with Previously Untreated Metastatic Colorectal Cancer – Genentech ML 25710 
Summary  This will be a randomized, open-label, multicenter, phase II study.  The study population with consist of first-line metastatic colorectal cancer patients. 
   
 Title   Symptom Burden and Quality of Life Outcomes in Advanced NSCLC Patients Treated in the Community Setting
 Summary  The purpose of this investigation of non-small cell lung cancer patients in the community oncology setting is to examine symptom burden and health related quality of life associated with a range of doublet treatments with and without bevacizumab in this population.


Orthopedics

Title  Retrospective Study of Patients Who Underwent Anterior Oblique Ligament (AOL) and Dorso-Radial Ligament (DRL) Reconstruction of the Carpo-Metacarpal (CMC) Joint of the Thumb
Summary  This is a retrospective chart review to assess radiographic congruency and subjective pain reduction in patients who have undergone AOL and DRL reconstruction at six months and one year following surgery.