Office of Research

Delivering quality clinical research

Talk to Us

Have questions for the Office of Research? Call our Clinical Trials team at 203.358.8879 or email officeofresearch@stamhealth.org.

The Office of Research coordinates research projects throughout the city of Stamford and surrounding areas, including both in-hospital and outpatient settings. The team provides:

  • Research/nurse coordinator and research assistant services
  • Budget preparation
  • Contractual assistance
  • Research regulatory compliance assistance
  • Serious adverse event (SAE) reporting
  • Site monitoring

Our experienced, multi-faceted team provides key assistance for many pharmaceutical and federally funded research trials. Our combined experience includes Phase 1 to Phase IV drug and device clinical trials.

Our mission and vision remain closely aligned with those of Stamford Health.

  • Mission: Provide a broad range of clinical trial opportunities that meets the needs of our community
  • Vision: To be recognized as a regional center for high quality Clinical Research

Latest Trials

NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) is a clinical trial that analyzes patients’ tumors to determine whether they contain genetic abnormalities for which a targeted drug exists (that is, “actionable mutations”) and assign treatment based on the abnormality. NCI-MATCH seeks to determine whether treating cancers according to their molecular abnormalities will show evidence of effectiveness. All specimens collected will undergo DNA sequencing to identify those which have genetic abnormalities that may respond to the targeted drugs selected for the trial. The drugs included in the trial have all either been approved by the U.S. Food and Drug Administration for another cancer indicating or are still being tested in other clinical trials but have shown some effectiveness against tumors with a particular genetic alteration.

Therapeutic Areas

We currently have trials in the following areas:

BREAST CANCER

(203) 358-8879

ALLIANCE A011202

Helen Pass, MD

Mary Miller, LPN

NCT01901094 A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease after Neoadjuvant Chemotherapy

NSABP B-51

Helen Pass, MD

Mary Miller, LPN

NCT01872975 A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

ALLIANCE

A011401

Steve Lo, MD

Mary Miller, LPN

NCT02750826 A Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer

ALLIANCE

A011502

Jamie Stratton, MD

Mary Miller, LPN

NCT02927249 A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive Her2 Negative Breast Cancer: The ABC Trial

SWOG S1207


Paul Weinstein, MD


Mary Miller, LPN

NCT01674140 Phase III Randomized, Placebo-controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk Hormone Receptor-Positive and HER2/NEU Negative Breast Cancer. e3 Breast Cancer Study- evaluating everolimus with endocrine therapy

Cascadian Therapeutics ONT-380-206

K. M. Steve Lo, MD

Mary Miller, LPN

NCT02614794 A Randomized Phase II Placebo-Controlled Study of ONT-380 Versus Placebo Plus Capecitabine & Trastuzumab in Progressive Locally Advanced Unresectable or Metastatic HER2+ Breast Cancer

Hologic

18-02

David Gruen, M.D.

Ian Goff

N/A

A Prospective image collection and reader study for clinical evaluation of commercially available handheld ultrasound unit

DFCI/HCC #17-512

K. M. Steve Lo, MD

Mary Miller, LPN

N/A

A randomized phase II trial of carboplatin with or without nivolumab in first- or second-line metastatic triple-negative breast cancer

DFCI #16-052

K. M. Steve Lo, MD

Mary Miller, LPN

 

NCT02764551

PELOPS: Palbociclib and Endocrine therapy for LObular breast cancer Preoperative Study: A randomized phase II study of Palbociclib with endocrine therapy versus endocrine therapy alone for Invasive Ductal Carcinoma

Merrimack         

MM121-02-02-10

K. M. Steve Lo, MD

Mary Miller, LPN

NCT03241810

SHERBOC: A Double-blind, Placebo-controlled, Phase 2 trial of Seribantumab Plus Fulvestrant in Postmenopausal Women with Hormone Receptor-positive, Heregulin Positive (HRG+), HER2 Negative Metastatic Breast Cancer Whose Disease Progressed After Prior Systemic Therapy 

Cardiology

(203) 358-8879

CardioMEMS

David Hsi, MD

NCT02279888 CardioMEMS CIP-10035 – HF System Post Approval Study

RADIANCE ReCor CLN0777

David Hsi, MD

NCT02649426 The “RADIANCE-HTN” Study A study of the ReCor Medical Paradise System in Clinical Hypertension

TACT2

David Hsi, MD

NCT02733185 A Randomized Double-blind, controlled factorial Clinical Trial of edetate disodium-based chelation and high-dose oral vitamins and minerals to prevent recurrent cardiac events in diabetic patients with a prior MI

Henry Ford

National CSI

Scott Martin, MD

N/A National Cardiogenic Shock Initiative (NCSI)

Luitpold

1VIT15043

David Hsi, MD

NCT03037931

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency

Novartis DCRI

CLCZ696BUS05T

David Hsi, MD

NCT03035474

CARE OPTIMIZATION THROUGH PATIENT AND HOSPITAL ENGAGEMENT CLINICAL TRIAL FOR HEART FAILURE

COLON CANCER

(203) 358-8879

SWOG          S0820

Salvatore Del Prete, MD


Ed Hatton, RN

NCT01349881 A Double Blind Placebo-Controlled Trial Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon Cancer, Phase III – Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)

HEMATOLOGIC MALIGNANCIES

(203) 358-8879

ALLIANCE Foundation AFT-28

Steve Lo, MD

Ed Hatton, RN

NCT02744092

Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

Celgene CONNECT MDS/AML Michael Bar, MD

Ian Goff

NCT01688011

CONNECT MDS/AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry

Celgene CC-4047-MM-014

Michael Bar, MD

Stacey Brian, RN

NCT0946477

A Phase 2, Multicenter, Multi-Cohort, Open Label Study of Pomalidomide in Combination with Low-Dose Dexamethasone or Pomalidomide in Combination with Low-Dose Dexamethasone and Daratumumab in Subjects with Relapsed or Refractory Multiple Myeloma Following Lenalidomide-Based Therapy in the First or Second-Line Setting

Stamford Hospital HOA 2012-01

Salvatore Del Prete, MD

Ed Hatton, RN

N/A

Incidence and Time Course of Anemia in Patients Receiving Platinum and/or Taxane-based Chemotherapy

Infectious Disease

(203) 358-8879

LUNG CANCER

(203) 358-8879

ALLIANCE A151216 Salvatore

Del Prete, MD

Ed Hatton, RN

NCT02194738 Adjuvant Lung Cancer Enrichment Mark Identification and Sequencing Trial (ALCHEMIST)

ALLIANCE A081105 Salvatore Del Prete, MD

Ed Hatton, RN

NCT02193282 Randomized, Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)

EA5142

Salvatore Del Prete, MD

Ed Hatton, RN

NCT02595944 Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) ~ A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancer (NSCLC)

E4512 Salvatore Del Prete, MD

Ed Hatton, RN

NCT02201992 A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

iSpecimen ISPC-160817-BLOOD

Suzanne Rose, PhD

Ian Goff

N/A

iSpecimen Network Protocol: "Collection and Distribution of Minimal Risk and Higher Volume Blood Biospecimens for Novel Research Uses."

Project 1073: NSCLC Plasma: K2EDTA 8-10ml of plasma from up to 100 unique donors with late stage (Stage III/IV by AJCC or UICC) non-small cell lung carcinoma (NSCLC) adenocarcinoma. Donors must be confirmed negative for EGFR at the time of collection

MELANOMA

(203) 358-8879

ECOG-ACRIN EA6134

Salvatore Del Prete, MD

Ed Hatton, RN

NCT02224781 A Randomized Phase III Trial in advanced BRAFV600 Mutant Melanoma at Disease Progression of Dabrafenib + Trametinib then Ipilimumab + Nivolumab versus Ipilimumab + Nivolumab then Dabrafenib + Trametinib

MOLECULAR

(203) 358-8879

ECOG-ACRIN

EAY131

K. M. Steve Lo, MD

Mary Miller, LPN

NCT02465060 Molecular Analysis for Therapy Choice (NCI-MATCH)

TSH-SADP-2015-01

Salvatore A. Del Prete, MD

Mary Miller, LPN

N/A Tumor Genomic Analysis Registry (TOGA)

SWOG S1609

Salvatore A. Del Prete, MD

Ed Hatton, RN

NCT02834013

S1609, "DART: DUAL ANTI-CTLA-4 AND ANTI-PD-1 BLOCKADE IN RARE TUMORS”

Nephrology

(203) 358-8879

Abbvie

SONAR-M11352

Eric Brown, M.D.

NCT01858532 A Randomized, Multicountry, Multicenter, Double-Blind, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects with Type 2 diabetes and Nephropathy-SONAR: Study of Diabetic Nephropathy with Atrasentan

Akebia

AKB-6548-Cl-0014

Eric Brown, M.D.

NCT02648347 PRO2TECT-CORRECTION – Phase 3, Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Oral AKB-6548 for the Correction of Anemia in Subjects with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)

Akebia

AKB-6548-Cl-0015

Eric Brown, M.D.

NCT02680574 PRO2TECT-CONVERSION – Phase 3, Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Oral AKB-6548 for the Maintenece Treatment of Anemia in Subjects with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)

Akebia

AKB-6548-Cl-0016

Eric Brown, M.D.

NCT02865850 INNO2VATE CORRECTION – Phase 3, Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects with Incident-Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

Akebia

AKB-6548-CI-       0017                      

Eric Brown, M.D. 

NCT02892149 INNO2VATE CONVERSION – Phase 3, Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenece Treatment of Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

OB/GYN

(203) 358-8879

Femasys Inc

CP-100-006 "BLOC"

Scott Chudnoff, MD

NCT03067272 Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception (BLOC trial)

Bayer

BAY 1002670/16953

Scott Chudnoff, MD

NCT03194646

An open-label, parallel-group, randomized, multicenter study to assess the safety and efficacy of vilaprisan in subjects with uterine fibroids versus standard of care

OVARIAN CANCER

(203) 358-8879

TapImmune

FRV-004

Salvatore Del Prete, MD

Ed Hatton, RN

NCT02224781

A randomized multicenter Phase II trial to evaluate the safety, efficacy and   immunogenicity of vaccination with Folate Receptor Alpha peptides admixed with GM-CSF as a vaccine adjuvant versus GM-CSF alone in patients with Platinum Sensitive Ovarian Cancer and a response or stable disease to platinum therapy”

PANCREATIC CANCER

(203) 358-8879

HALOZYME HALO-109-301

Salvatore

Del Prete, MD

Ed Hatton, RN

NCT02715804

Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination with nab-Paclitaxel Plus Gemcitabine Compared with Placebo Plus nab-Paclitaxel and Gemcitabine in Subjects with Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

PROSTATE CANCER

(203) 358-8879

Astellas ONC-MA-1004

Anthony Gulati, MD

Ed Hatton, RN

NCT02380274 A Prospective Observational Cohort Study of Patients with Castration-Resistant Prostate Cancer (TRUMPET)

Hoffmann-LaRoche

CO39385

Anthony Gulati, MD

Ed Hatton, RN

NCT03016312 A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-Pd-L1 Antibody) In Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of An Androgen Synthesis Inhibitor And Failure Of, Ineligibility For, Or Refusal Of A Taxane Regimen

Pulmonology

(203) 358-8879

Veracyte
Percepta-R1

Michael Bernstein, MD

N/A

Prospective Registry to Evaluate Percepta Bronchial Genomic Classifier Patient Data: The PERCEPTA Registry

GlaxoSmith Kline

GSK 2269557

Paul Sachs, MD

NCT03345407

 A Phase IIb, Randomized (Stratified), Double-Blind (Sponsor Open), Parallel-Group, Placebo-Controlled, Dose-Finding Study of Nemiralisib (GSK2269557) Added to Standard of Care (SoC) Versus SoC Alone in Participants Diagnosed withan Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

Radiology

(203) 358-8879

Hologic          

15-002-B- RA

David Gruen, M.D.

N/A                 A Feasibility Study for SuperTomo Imaging of the Breast

Hologic

15-002-C-Int

David Gruen, M.D.

N/A Evaluation of Mammographic Positioning Platforms and Compression Immobilization Systems

Hologic

17-09

David Gruen, M.D.

N/A

Feasibility study for Tomosynthesis device with enhanced comfort features

Hologic

2016-03

David Gruen, M.D.

N/A

Breast Compression: Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle

Hologic

18-02

David Gruen, M.D.

N/A

A Prospective image collection and reader study for clinical evaluation of commercially available handheld ultrasound unit