Clinical Trials

Doylestown Health's robust research program offers patients access to a broad range of clinical trials including heart and vascular studies. Clinical trials test new and innovative treatments and therapies, which are a critical part of advancing medicine. All clinical trials offered by Doylestown Health are approved and closely monitored by the IRB (Institutional Review Board).

Doylestown Health's Cancer Institute is a member of the Eastern Cooperative Oncology Group (ECOG), one of the largest clinical cancer research organizations in the United States, and conducts clinical trials in all types of adult cancers. ECOG is funded by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH).

Contact:

Jim Cain, MSN, RN
Oncology Research Nurse
215.345.2378
JCain@dh.org

Doylestown Health is currently enrolling patients in the following approved oncology protocols:

All Cancers

Cancer Experience Registry Survey about your cancer experience Allows the Cancer Institute to continually enhance our design of support services, effective policy and impactful research www.cancerexperienceregistry.org/join/DH

Breast

NRG-BR003

A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node Negative, Triple-Negative Invasive Breast Cancer
  • To determine if the addition of carboplatin to an adjuvant chemotherapy regimen of AC + T will improve invasive disease free survival in patients with triple negative breast cancer

S1418

A Randomized Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with >/= 1cm Residual Invasive Cancer of Positive Lymph Nosed After Neoadjuvant Chemotherapy*
  • To compare iDFS of patient population receiving Pembrolizumab compared to no Pembrolizumab
  • May enroll after treatment with Xeloda

S1703

Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored With Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients with Metastatic Hormone Receptor Positive Breast Cancer*
  • To assess whether patients monitored with STMDDM have non-inferior OS compared to patients monitored with usual care (imaging).

Prostate

IRONMAN

Prostate Cancer Outcomes: An International Registry to Improve Outcomes in Men with Advanced Prostate Cancer
  • International study
  • Non-therapeutic prospective registry
  • Metastatic hormone sensitive prostate cancer
  • Castration resistant prostate cancer
  • To describe the practice patterns of therapeutic agents for treatment of advance prostate cancer internationally
  • To assess whether specific treatment patterns are associated with clinically significant adverse events and evaluate potential interactions with concomitant medications or demographic factors
  • To identify associations between treatment sequences or combinations and overall survival
  • To define the patient experience of men with advance prostate cancer and identify unmet needs in their treatment
  • To identify clinical and molecular disease subtypes that predicts response to individual treatments, combination, or sequences.
  • Blood biomarkers
  • Physician questionnaires with changes in treatment

PROPEL

PROmoting Prostate Cancer Engagement and Learning: Feasibility of Digital Health Coaching for Men with Prostate Cancer
  • Men who have been treated for prostate cancer within two years
  • Will receive virtual health coaching through digital platform Pack Health
  • Weekly contact with coach via text, email or phone for 12 weeks
  • Coaches provide resources to help achieve health and wellness goals while living with prostate cancer
  • Complete surveys every 4 weeks

Colon

NRG-GI005 (COBRA)

Phase II/III Study of Circulating tumOr DNA as a Predictive BiomaRker in Adjuvant Chemotherapy in Patients with Stage IIA colon Cancer (COBRA)
  • To determine whether to recommend chemotherapy or no further treatment after surgery for an early stage colon cancer by taking a blood sample and testing for the presence of circulating tumor DNA
  • Patient must be “suitable for active surveillance” i.e. the physician decides no adjuvant chemotherapy is needed

Lung

A081801 (ALCHEMIST I-O)

Integration of Immunotherapy into Adjuvant Therapy for Resected NSCLC: ALCHEMIST I-O
  • Stage IB-IIIA resected NSCLC
  • Compares DFS and OS between combination or sequential Pembrolizumab plus standard of care vs. standard of care

Bladder

A031501 (AMBASSADOR)

Phase III Randomized Adjuvant Study of MK-3475 (Pembrolizumab) in Muscle Invasive and Locally Advanced Urothelial Carcinoma (AMBASSADOR) Versus Observation*
  • To determine DFS and OS in patients treated with Pembrolizumab versus observation
  • Tissue sample for Central PD-L1 testing for stratification purposes

Molecule Targets

NCI-MATCH/EAY131

National Cancer Institute – Molecular Analysis for Therapy Choice
  • Phase II precision medicine trial that seeks to determine whether matching certain drugs or drug combinations in adults whose tumors have specific gene abnormalities will effectively treat their cancer, regardless of its type
  • Solid tumor, lymphoma, or myeloma that has returned or gotten worse after standard systemic therapy
  • Any cancer for which no standard treatment exists that has been shown to prolong overall survival
  • Patients identified when tumor gene testing done by designated laboratories

TAPISTRY

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for Your (TAPISTRY) Phase II Platform Trial
  • Evaluate the efficacy and safety of multiple therapies that are selected using somatic alterations and potential predictive biomarkers identified via NGS assays in patient with solid tumors
  • Biomarkers include: ROS1 fusion (non-NSCLC), NTRK1/2/3 fusion, ALK fusion (non-NSCLC), PIK3CA multiple mutations, AKT1/2/3 mutation, HER2 mutation, MDM2-amplified, TP53 wild-type, and TMB-high (>/= 16 mut/Mb)

Other

NCI-COVID

NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History Study
  • To determine how COVID-19 affects the outcomes of people undergoing cancer treatment
  • To determine how having cancer affects COVID-19
  • Collection of blood samples, medical imaging, medical and cancer history
  • Must enroll within two weeks of positive COVID-19 test

Commission on Cancer Standard 9.1

For more information about Doylestown Health's open cancer trials visit the U.S. National Institutes of Health's Clinical Trials database.

 

Doylestown Health's gastroenterology team participates in clinical trials and research to help shape the way gastrointestinal disease is treated.

Active Trials: Not Accepting New Patients

Non-alcoholic Stearotic Hepatitis (NASH, fatty liver) - REGENERATE (NASH)

  • Evaluating the impact on NASH with fibrosis of obeticholic acid treatment
  • Coordinated by the Doylestown Health Medical Research Department: 215.345.2119

Active Trials: Not Accepting New Patients

Moderate to severe Ulcerative Colitis - UNIFI

  • Evaluating the safety and efficacy of ustekinumab induction and maintenance therapy in participants with moderately to severely active ulcerative colitis
  • Enrolled patients in follow up through February 2020

For more information about Doylestown Health's open trials, visit the U.S. National Institutes of Health's Clinical Trials database.

Heart and Vascular Active Trials - Open

Narrowing of Carotid Artery (asymptomatic) - CREST-2

  • Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
  • An NIH study for patients who have significant narrowing of the carotid artery who have not experienced stroke symptoms (asymptomatic)
  • This four-year study includes close monitoring and intense medical management to reduce stroke risk factors including control of high blood pressure, cholesterol, diabetes, smoking cessation, diet and exercise. The study compares carotid endarterectomy (CEA) with medical management vs carotid stenting (CAS) with medical management vs just medical management
  • Open to enrollment

CREST-2 Registry

  • A companion study to the CREST-2 trail offering CREST-2 approved and conditional approved interventionists an opportunity to expand their expertise in performing CAS so they can fully participate in C2
  • All eligible CAS cases performed by study interventionists are registered so they can be reviewed
  • Open to enrollment

TAVR and Atrial Fibrillation – ENVISAGETAVI - AF

  • Edoxaban (a new, oral anticoagulant) Compared to Standard Care ( Coumadin)After Heart Valve Replacement Using a Catheter in Patients with Atrial Fibrillation
  • Patients will be followed for 3 year
  • Open to enrollment

Coronary Artery Disease - PIONEER III

  • Trial to Assess Safety and Efficacy of a new stent platform for drug eluting stents for the coronary arteries
  • Patients will be followed for 5 years
  • Open to enrollment

High Risk Bleeders needing Coronary Stenting – XIENCE- 90

  • The objective of this trial is to evaluate safety of a 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing Percutaneous Coronary Intervention (PCI) with a Xience stent.
  • Patients are followed for 1 year
  • Open to enrollment

ADVENT

Sponsor = FARAPULSE.

Principal Investigator = Dr. John Harding

Pts are randomized to either cryo balloon PVI (50%) or pulse field ablation (50%).

Patients with drug-resistant paroxysmal AF meeting ALL the following criteria:

  • Paroxysmal: AF that terminates spontaneously or with intervention within 7 days of onset.
  • Frequency: within 12 months of enrollment: >2 episodes of clinically confirmed symptomatic PAF At least one documented episode by a recording such as ECG, event monitor, holter or telemetry strip.
  • Drug Failed: Failed antiarrhythmic drug (AAD) treatment, meaning therapeutic failure of at least one AAD (class I-IV) for efficacy or Intolerance.
  • Patients who are >18 and <75 years of age on day of enrollment
Patient participation requirements:
  • Willing and capable of providing Informed Consent to undergo study procedures
  • Willing to participate in all examinations and follow-up visits and tests associated with this clinical Study.

For more information call 215.933.0053

Pulsed

Sponsor = MEDTRONIC.
Principal Investigator = Dr. Rob Sangrigoli.

Patients are ALL receiving PVI via pulse field ablations.Inclusion criteria:
  1. Failure of at least one AAD (class I or III) for AF as evidenced by recurrent symptomatic AF, or intolerable side effects due to AAD.
  2. A diagnosis of recurrent symptomatic paroxysmal or persistent AF with the following documentation:
    • Paroxysmal:
      • Physician’s note indicating symptoms consistent with recurrent self-terminating(within 7 days)AF or paroxysmal AF;
      • and any 24 continuous ECG recording documenting Persistent AF within 6 months of enrollment;
        OR (2) two ECGs from any form of rhythm monitoring showing continuous AF taken at least 7 days apart.
    • Persistent:
      • Physicians note indicating symptoms consistent with continuous AF episode lasting longer than 7 days but less than 1 year:
      • and any EKG documented AF episode(s) within 12 months prior to enrollment.
  3. Age 18-80 years old (or older than 18 if required by law).

 

Heart and Vascular Active Trials - Closed

Coronary Artery Disease - ABSORB III & IV

Enrolled patients in follow up through September 2021

Coronary Artery Disease – BIONICS

Enrolled patients in follow up through August 2020

Coronary Artery Disease – PROMUS CLOSED

Enrolled patients in follow up through April 2018

Heart Attack – ARTEMIS CLOSED

Enrolled patients in follow up through December 2017

Peripheral Artery Disease - MIMICS-2

Enrolled patients in follow up through June 2019

Paroxysmal or persistent atrial fibrillation with high blood pressure - SYMPLICITY AF

To evaluate the feasibility of performing both renal artery denervation and pulmonary vein isolation on the same patient to characterize both safety and effectiveness in patients with high blood pressure who have paroxysmal (occasional episodes) or persistent (lasting more than seven days) atrial fibrillation.

These clinical trials are coordinated by the Doylestown Health Medical Research Department: 215.345.2119.

Upcoming Trials - Not Yet Enrolling:

Influenza A – DIAMOND

  • To evaluate the Safety and Efficacy of a new oral drug in combination with standard of care treatment in non-hospitalized patients with Influenza A who are at risk of developing complications

Influenza A - SAPPHIRE

  • To evaluate the Safety and Efficacy of a new JNJ oral drug in combination with our standard of care in hospitalized patients with influenza A.


These clinical trials are coordinated by the Doylestown Health Medical Research Department: 215.345.2119.

Active Trials - Open to Enrollment:

Anemia Related to Non-dialysis-dependent Chronic Kidney Disease - Akebia Therapeutics

  • Efficacy and safety study to Evaluate Vadadustat for the maintenance treatment of anemia in Subjects with Non-dialysis-dependent chronic kidney disease
  • Compares an investigational oral medication vs the standard injectable medication

Anemia in Chronic Kidney Disease - MONOFER

  • A study is comparing Venofer IV iron (standard) vs Monofer IV iron (investigational)
  • Monofer IV Iron is a one-time infusion of iron over 20 minutes vs Venofer IV Iron which is an hour and a half infusion which is usually given five times over the course of three to four weeks

These clinical trials are coordinated by the Doylestown Health Medical Research Department: 215.345.2119.

Upcoming Trials - Not Yet Enrolling:

Acute Ischemic Stroke - QUEST-KETA

  • Quelling of Excitotoxicity in Acute Stroke with Ketamine (QUEST-KETA) trial will investigate the efficacy and side effects of IV Ketamine to reduce neuroexcitotoxicity, and thus provide neuroprotection in patients diagnosed with acute ischemic stroke.

These clinical trials are coordinated by the Doylestown Health Medical Research Department: 215.345.2119.

Active Trials - Open to Enrollment:

Non-Cystic Fibrosis Bronchiectasis - The Willow Study

  • Study will evaluate the efficacy and tolerability of an oral anti-inflammatory medication vs. placebo
  • Non-Cystic Fibrosis Bronchiectasis is a progressive disorder associated with airway dilation and bronchial wall thickening.

For more information about Doylestown Health's open trials visit the U.S. National Institutes of Health's Clinical Trials database.

Clinical Trials FAQs

Here are answers to frequently asked questions about Doylestown Health clinical trials:

Clinical trials must take place before new research treatments or devices can be made available to the public. Trials are designed to help determine the safety and effectiveness of new treatments and additional possibilities for patients facing certain medical conditions.

For clinical trials to be successful, we rely on patient volunteers who meet specific criteria to participate in these studies. The ultimate goal of a clinical trial is to obtain knowledge that can then be used to improve the health and well-being of various patient populations.

Choosing to participate in a clinical trial is an important personal decision. To make a fully informed decision, before deciding whether to participate in a study, it is often helpful to talk to your health care provider, family members, or friends. After you have identified trial options, the next step is to contact the study research staff and ask questions about specific trials.

Many guidelines are in place for patient volunteers, by Doylestown Health, the sponsoring company, and at the Federal level (FDA).

If you are interested in participating in a clinical trial you may call Doylestown Health's Medical Research department at 215.345.2119 and speak with one of our research coordinators to answer any questions you may have regarding a clinical trial or review trials available.

Institutional Review Boards are established to ensure the rights and welfare of people who choose to participate in clinical trials both before and during their trial participation. The primary function of the IRB is to guarantee adherence to all federal, state, local, and institutional regulations concerning the protection of all human subjects when testing investigational drugs or medical devices. These impartial review panels assess the risks and benefits of each study trial to minimize and fairly disclose risk to study participants.

Doylestown Health is committed to being a foremost clinical research center where standards of care are elevated both now and in the future.

Additional Clinical Trials Information

For more information about Doylestown Health's open trials visit the U.S. National Institutes of Health's Clinical Trials database.