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Clinical Trials

Clinical Trials 2018-10-04T10:51:59+00:00

CentraState Medical Center is proud to offer eligible patients access to promising new developments in the treatment and prevention of medical conditions such as cancer and chronic pain through our participation in clinical trials. Clinical trials are studies designed to test new therapies, medicines, or medical devices in humans after they have been fully tested in the laboratory and in animals but before they are available to the general public.

The clinical trials offered at CentraState are the same as those offered at major health care centers nationwide, and they are managed by specialists who hail from some the finest medical institutions in the country.

732-294-5874
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732-294-5874
REQUEST INFORMATION

CentraState Medical Center is proud to offer eligible patients access to promising new developments in the treatment and prevention of medical conditions such as cancer and chronic pain through our participation in clinical trials. Clinical trials are studies designed to test new therapies, medicines, or medical devices in humans after they have been fully tested in the laboratory and in animals but before they are available to the general public.

The clinical trials offered at CentraState are the same as those offered at major health care centers nationwide, and they are managed by specialists who hail from some the finest medical institutions in the country.

Although clinical trials and other forms of research have led to significant improvements in the medical field, patient safety, privacy, and rights always take precedence. That’s why the federal government requires that every institution that conducts medical research with public funds must establish an Institutional Review Board (IRB).

CentraState’s IRB ensures that biomedical and behavioral research is conducted ethically at our facility and complies with federal rules and regulations for the protection of trial participants. The IRB reviews studies before and during research to protect patient rights and welfare. Our IRB has 10 members with relevant medical, scientific, and social services backgrounds. Two are community members with no other ties to CentraState Medical Center. In addition, there are five designated alternate IRB members.

Patients must be referred to a clinical trial by a participating trial physician. If you and your physician believe you fit the criteria for a clinical trial, contact us and we will set up an evaluation appointment with a participating physician.

Clinical trials have specific eligibility criteria. A participating trial physician and our clinical research nurse will work with you to determine if you meet them.

Clinical trials are tightly controlled. They require a significant commitment from the participating medical team and their patients. To determine the effects of the therapies, medicines, or devices being studied, patients must be monitored closely. Ongoing physical exams, diagnostic imaging studies (such as X-rays), and blood tests may be part of the trial process.
In addition to overseeing the administrative components of the trial and serving as the liaison between the medical center and the trial sponsor, CentraState’s clinical research nurse works closely with patients and their families to help make the trial process flow smoothly. She helps patients understand informed consent forms, coordinates appointments, documents results, answers questions, and provides support and guidance throughout the research process.

OPEN CLINICAL TRIALS

Listed below are brief descriptions of the clinical trials CentraState Medical Center is currently participating in.

For more information on any of the trials listed, contact CentraState’s Research Department by telephone at (732) 294-5874 or by email to JCraig@centrastate.com.

In addition to the below trials, CentraState also offer over 25 additional clinical trials through the RCCA medical oncology offices of Dr. Balar and Dr. Silberberg, located in Freehold, NJ. For a complete list, call 732-431-8400.

BREAST CANCER

Study Title: ICE SENSE™ 3 Cryotherapy for Breast Cancer: Cryoablation of Low Risk Breast Cancers less Than 1.5 cm: An Evaluation of Local Recurrence

Protocol Number: ICMBC-02, CSMC 2014-07

Co-Principal Investigators: Susan Boolbol, MD, Beth Israel Medical Center, NY, NY

Kenneth Tomkovich, MD, CentraState Medical Center

Description: The objective of this study is to evaluate the efficacy of cryoablation without lumpectomy at its impact on local and distant recurrence of low risk early breast cancer in women 65 years or older.

General Eligibility: Patients must have a diagnosis of invasive ductal breast cancer by needle core biopsy, tumor size 1.5 cm or less; have clinically negative nodes and age 65 or older.

PROSTATE CANCER

Study Title: PARTIQol: Prostate Advanced Radiation Technologies Investigating Quality of Life: A Phase III Randomized Clinical Trial of Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer.

Protocol Number:  #11-497, CSMC 2015-11

Principal Investigators: Jason A.  Efstathiou, MD, D.Phil., Massachusetts General Hospital

Co-Principal Investigators:  Oren Cahlon, MD, Princeton Radiology Oncology

Description:  This is a Phase III randomized clinical trial directly comparing proton radiation therapy to intensity modulated photon radiation therapy (IMRT).  The hypothesis is that proton therapy will result in improved patient reported outcomes for a given radiation dose.

General Eligibility:  Males diagnosed with confirmed adenocarcinoma of the prostate based on core biopsy samples; Clinical states T1c to T2b, PSA < 20.

Study Title: A Prospective Observational Registry of H.P. Acthar® Gel For The Treatment of Multiple Sclerosis Relapse

Protocol Number: MNK 14130050; CSMC: 2016-03

Sponsor: Mallinckrodt Pharmaceuticals

Principal Investigator:  Amos Katz, MD

Description:  This observational study aims to characterize the patient population and describes multiple sclerosis exacerbation recovery, treatment patterns and safety outcomes in patients with multiple sclerosis experiencing exacerbations treated with H.P. Acthar® Gel in standard practice in the United States.

General Eligibility:  Male or female patients over age 18, clinically definite relapsing form of multiple sclerosis, planning to initiate Acthar® Gel for the treatment of acute multiple sclerosis.

Study Title: MITIGATE: A Multicenter, Double-Blind, Placebo-Controlled Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera® (Dimethyl Fumarate) Delayed-Release Capsules.

Protocol Number: 109MS414

Sponsor: Biogen Idec MA, Inc.

Principal Investigator:  Amos Katz, MD

Description:   This study will investigate the impact of 10 mg of montelukast once daily on GI tolerability in patients with relapsing forms of MS receiving Tecfidera® delayed-released capsules in order to potentially increase patient compliance and adherence to treatment and ultimately maximize the therapeutic potential of Tecfidera®.

General Eligibility:  Males and females over age 18, must reside in the USA, have a confirmed diagnosis of a relapsing form of multiple sclerosis and satisfy the therapeutic indications, female subjects of childbearing potential who are not surgically sterile must practice effective contraception during participation in study and be willing and able to continue contraception for 30 days after the last dose of Tecfidera®.

Study Title: A Prospective, 24 month, Observational Study to Evaluate Patient Reported Outcomes (PROs) and Safety After LEMTRADA® Treatment in Patients With Relapsing Multiple Sclerosis Switching  From a Prior Disease Modifying Therapy.

Protocol Number: OBS 14448, CSMC 2016-03

Sponsor:  Sanofi

Principal Investigator:  Amos Katz, MD

Description:  The primary objective of this study is to evaluate treatment satisfaction as the primary PRO in patients with relapsing forms of multiple sclerosis treated with Lemtrada® in real life settings.

General Eligibility:  Adult patients with relapsing multiple sclerosis transitioning from a prior disease modifying therapy to Lemtrada®.

 

Study Title: Long-Term, Prospective, Multinational, Parallel-Cohort Study Monitoring Safety in Patients With Multiple Sclerosis Newly Started on Fingolimod Once Daily or Treated With Another Approved Disease Modifying Therapy.

Protocol Number:  CFTY720D2403, CSMC 2013-02

Sponsor:  Novartis

Principal Investigator:  Amos Katz, MD

Description:  The purpose of this study is to further monitor the overall safety profile of fingolimod under conditions of routine medical practice and to explore the incidence of selected safety-related outcomes.

General Eligibility:  Patients with multiple sclerosis that have started fingolimod at the time of study entry; or starting, or have started within six months prior to study entry, another approved multiple sclerosis disease modifying therapy.

Study Title: Comparison of Pain Levels in Single-Site vs. Multiple-Site Laparoscopic Cholecystectomy Patients

Protocol Number:  CSMC 2015-09

Sponsor:  CSMC

Principal Investigator:  Amit Kharod, MD.  Co-Investigator:  Rebecca Norton, RN

Description:  The purpose of this study is to study self-reported measures of pain in patients undergoing single or multiple site laparoscopic cholecystectomy.

General Eligibility:  Patients undergoing planned laparoscopic cholecystectomy either through multiple or single incision approach, over 18 years old, English-speaking, and willing to provide pain levels they experience after surgery.

Study Title: ARAMIS: Management of Acute Stroke Patients on Treatment With New Oral Anticoagulants: Addressing Real-World Anticoagulant Management Issues in Stroke, Registry.

Protocol Number:  CSMC 2016-06

Sponsor:  Duke Clinical Research Institute

Principal Investigator:  Ellen Ciacciarelli, APN, CCRN

Description:  The primary goal of this study is to address several key treatment and management issues surrounding patients with either acute ischemic stroke or intracranial hemorrhagic stroke on anticoagulant therapy.

General Eligibility:  Patients who have been diagnosed with acute ischemic stroke and have been treated with dabigatran, rivaroxaban, apixaban, edoxaban within 7 days prior to admission, or have been diagnosed with intracerebral hemorrhage and have been treated with warfarin or one of the new oral anticoagulants within 7 days prior to admission.

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