Current Studies

The Office of Research at Saint Peter’s University Hospital is currently managing over 20 different clinical studies.  Of these, here is a sampling of some of the groundbreaking trials that are currently enrolling new patients:
 
Adult Oncology Drost, Charlene Celgene Corporation MDS/AML Connect MDS/AML Disease Registry
Adult Oncology Maney, Susan GOG GOG-0237 Comparative analysis of CA-IX, P16, Proliferative markers, and human papilloma virus (HPV) in the diagnosis of significant cervical lesions in patients with cytologic diagnosis of atypical glandular cells (AGC)
Adult Oncology Drost, Charlene Pharmacyclics PCYC-1134M A Disease Registry for Patients With Chronic Lymphocytic Leukemia (informCLL)
Adult Oncology Maney, Susan NRG BR003 Randomized 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
Adult Oncology Drost, Charlene Pled Pharma PP06490 (POLAR-M) A Phase 3, double-blind, multicenter, placebo-controlled study of PledOx used on top of modified FOLFOX6 (5-FU/FA and Oxaliplatin) to prevent chemotherapy induced peripheral neuropathy (CIPN) in patients with first-line metastatic colorectal cancer
Adult Oncology Maney, Susan Precision Rad/Onc Lung Immunotherapy A Prospective Trial Of Immunotherapy And Stereotactic Body Radiotherapy (Sbrt) For The Treatment Of Metastatic Lung Cancer: Sbrt Sensitization Of The Programmed Death-1 (Pd-1) Effect
Adult Oncology Maney, Susan RTOG RTOG 1005 A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost of Early Stage Breast Cancer
Breast Surgery Maney, Susan Alliance A011401 Randomized trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer
Breast Surgery Maney, Susan ECOG EA1151 Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
Dept. of Anesthesiology Drost, Charlene Pacira 402-C-414 A Multicenter, Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of EXPAREL, when Administered via Infiltration into the Transversus Abdominis Plane versus Standard of Care in Subjects Undergoing Elective Cesarean Section
Maternal Fetal Medicine Perez, Clara National Institute Of Health HCV study An Observational Study of Hepatitis C Virus in Pregancy
Maternal Fetal Medicine Otarola, Sol Columbia University AAAR4976 (ECCHO-NFGS) Environmental Contributors to Child Health Originating from the National Fetal Growth Study (ECCHO-NFGS)
Maternal Fetal Medicine Davis, Shoan Columbia University The CPR Study Cholestasis of pregnancy and the PR interval: the CPR study
Maternal Fetal Medicine Otarola, Sol Natera 14-024-NPT (SMART) SNP-based Microdeletion and Aneuploidy RegisTry (SMART) (SMART)
Maternal Fetal Medicine Davis, Shoan Rutgers University PRN Collaboration (AAAR1870) Does the Cerebroplacental Ratio (CPR) Predict Adverse Outcomes in Low Risk Pregnancies? (CPR)RU010312017
Maternal Fetal Medicine Falk, Michele Columbia University AAAR1388 (TOPS) A Randomized trial of pessary in singleton pregnancies with a short cervix
Maternal Fetal Medicine Perez, Clara Columbia University AAAR5624 (ALPS FSP) Childhood Pulmonary Complication
Maternal Fetal Medicine Falk, Michele Columbia University AAAR5971 (ALPS Neuro) Childhood Cognitive Function in a birth cohort after a randomized trial of antenatal corticosteroids: The ALPS Neurocognitive follow up study.NIH
Maternal Fetal Medicine Perez, Clara Columbia University AAAR6736 (TXA) Tranexamic Acid for the prevention of obstetrical hemorrhage after cesarean delivery: A Randomized Controlled Trial
Maternal Fetal Medicine Davis, Shoan Columbia University AAAR7108 (Exosome CMV/Zika) Maternal Plasma Exosome Testing to Detect Fetal Brain Injury Following CMV or Zika Infection
Maternal Fetal Medicine Falk, Michele Columbia University PROSPECT A randomized trial of Pessary and Progesterone for Pretern Prevention in Twin Gestation with a short cervix
Maternal Fetal Medicine Perez, Clara NICHD CMV Study A Randomized Trial to Prevent congenital cytomegalovirus infection CMV
Maternal Fetal Medicine Falk, Michele University of Alabama at Birmingham CHAP Chronic hypertension and Pregnancy Project (CHAP)1U01HL119242-01
Maternal Fetal Medicine Otarola, Sol University of North Carolina MOMPOD Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD) Study5R01HD086139-025109533
Maternal Fetal Medicine Davis, Shoan Illumina NIPT-C00-002 Prospective Collection of Whole Blood Specimens From Pregnant Women at Any Risk of Fetal Chromosomal Anomaly for the Development of a Noninvasive Prenatal Test
Maternal Fetal Medicine Davis, Shoan Columbia University Pro-129 Preeclampsia Collection of Whole Blood Samples for the Evaluation of Preeclampsia (PRE-E) Biomarkers from Pregnant Women
Maternal Fetal Medicine Falk, Michele Illumina RGH-014 Prospective Collection of Blood Specimens in Pregnant Women Diagnosed with Preterm Preeclampsia and/or Fetal Growth Restriction in Support of Molecular Assay Development
Maternal Fetal Medicine Davis, Shoan Natera 12-014-NPT Development of Non-Invasive Prenatal Diagnostic for Micro deletion/ Micro duplication and Other Genetic Disorders Based on Fetal DNA Isolated from Maternal Blood
Maternal Fetal Medicine Davis, Shoan Progenity PRO-101-SAMPLES Whole Blood sample collection from pregnant subjects
Maternal Fetal Medicine Davis, Shoan Sequenom Inc SQNM-T21-107 Collection of Whole Blood Specimens from Pregnant Women at Increased Risk for Fetal Chromosomal Abnormality for use in Development of a Noninvasive Prenatal Test in the Detection of the Relative Quantity of Chromosomal Material in Circulating Cell-Free DNA Extracted from Maternal Plasma
OB/GYN Moser, Barbara SPUH Peri Cleansing Protocol Peri Cleansing Protocol for the Laboring Patient to Prevent Chorioamniotis: A Randomized Controlled Trial (PCP)
Pediatric Neurology McMahan, Shona Aquestive (MonoSol) 160325 A Multicenter, Open Label, Cross-Over Study to Assess the Pharmacokinetics and Safety of Diazepam Buccal Soluble Film (DBSF) in Pediatric Subjects with Epilepsy
Pediatric Neurology McMahan, Shona Aquestive (MonoSol) 42-1703 An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Buccal Soluble Film (DBSF) in Pediatric, Adolescent and Adult Subjects With Epilepsy
Pediatric Neurology McMahan, Shona Neurelis DIAZ.001.04 An Open-Label, Repeat-Dose Pharmacokinetic Study Of Nrl-1 In Epilepsy Subjects Under Seizure And Normal Conditions
Pediatric Neurology McMahan, Shona Neurelis DIAZ.001.05 A 12-Month, Open-Label, Repeat-Dose Safety Study Of Nrl-1 In Epilepsy Subjects
Pediatric Neurology McMahan, Shona Ovid Therapeutics TAK-935-2002 (ELEKTRA) A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy, Safety, And Tolerability Of Tak-935 As An Adjunctive Therapy In Pediatric Patients With Developmental And/Or Epileptic Encephalopathies
Pediatric Neurology McMahan, Shona Ovid Therapeutics TAK-935-18-001 (OV935) A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study To Assess The Long-Term Safety And Tolerability Of Tak-935 As Adjunctive Therapy In Patients With Rare Epilepsy
Pediatric Neurology McMahan, Shona UCB Biosciences EP0060 A Multicenter, Open-Label Study to Investigate the Safety and Tolerability of Intravenous Lacosamide as Replacement for Oral Lacosamide in Children (=4 to <17 years of age) with Epilepsy
Pediatric Neurology McMahan, Shona UCB Biosciences EP0065 A Multicenter, Open-Label Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Intravenous Brivaracetam In Subjects =1 Month To <16 Years Of Age With Epilepsy
Pediatric Neurology McMahan, Shona UCB Biosciences N01266 Open-Label, Single-Arm, Multicenter, Long-Term Follow-Up Study To Evaluate Safety And Efficacy Of Brivaracetam Used As Adjunctive Treatment In Pediatric Subjects With Epilepsy
Pediatric Neurology McMahan, Shona UCB Biosciences EP0092 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy And Safety Of Padsevonil As Adjunctive Treatment Of Focal-Onset Seizures In Adult Subjects With Drug-Resistant Epilepsy
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) ALTE03N1 Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) ALTE05N1 Umbrella Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) APEC14B1 EveryChild A Registry, Eligibility Screening, Biology and Outcome Study
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) APEC1621SC (MATCH) Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) AREN03B2 Renal Tumors Classification, Biology, and Banking Study
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) AALL1131 A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (IND#73789, NSC#732517) in Patients with Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) AALL15P1 Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) APEC1621C Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial)
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) AALL1331 Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) AALL1621 A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND# 133494) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) ACNS0831 Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Younger Patients With Newly Diagnosed Ependymoma
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) ACNS1422 Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) AHOD1331 A Randomized Phase III Study of Brentuximab Vedotin Newly Diagnosed High-Risk Classical Hodgkin Lymphoma in Children and Adolescents
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) ANBL1232 Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) APEC1621A Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial)
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) APEC1621B Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) APEC1621D PI3K/mTOR Inhibitor LY3023414 in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial)
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) APEC11621E Selumetinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) APEC1621F Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) APEC1621G Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric MATCH Treatment Trial)
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) APEC1621H Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial)
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) ARST1431 A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS)
Pediatric Oncology Zaidi, Naureen Childrens Oncology Group (COG) ANBL00B1 Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma
Radiation Oncology Maney, Susan Radiosurgery Society RSSearch Patient Registry RSSearch Patient Registry for Patients who may be Treated with Radiosurgery at Saint Peter's University Hospital
Radiation Oncology Maney, Susan SPUH Dysphagia QOL Dysphagia After Irradiation to Pharyngeal Constrictor Muscles Measured in Terms of Quality of Life
Radiation Oncology Maney, Susan SPUH Lung Cancer Registry Lung cancer registry study - Cyberknife® Radiosurgery VS external beam radiation therapy
Radiation Oncology Maney, Susan SPUH Breast Cyberknife A Pilot Study of Partial Breast CyberKnife® for Postmenopausal Women 50 Years of Age or Older with DCIS or Stage I Breast Cancer

 

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