Patient Clinical Trials

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747-302

Topic of Study: Gastrointestinal Disease
Sponsor: Intercept
Principal Investigator: Paul J. Thuluvath, M.D., FRCP, 410-332-9356
Research Coordinator: Olivia Tang, 410-843-2069
For More Information: otang@mdmercy.com
Coordinated Through: The Institute for Digestive Health and Liver Disease

This study is a phase 4 trial evaluating the effect of obeticholic acid on clinical outcomes in patients with primary biliary cholangitis. (302)

 

A Cohort Study of the Gastrointestinal Microbiome in Appendiceal Cancer

Topic of Study: Appendiceal Cancer
Principal Investigator: Armando Sardi, M.D. 410-332-9294
Research Coordinator: Michelle Sittig, RN, 410-332-9294
For More Information: 410-332-9294
Coordinated Through: Surgical Oncology at Mercy

The primary aim of the study is to determine whether the gastrointestinal microbiome of appendiceal cancer patients with peritoneal spread differs from a healthy, age-matched cohort of the American population. This is a collaborative study with the University of California, San Diego and Rob Knight, PhD who will perform the genetic analysis of bio-specimens from patients who undergo cytoreductive surgery with HIPEC. (Clinical Trials ID #: NCT02599116) 

A Phase 3, Randomized, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer

Topic of Study: Ovarian Cancer
Sponsor: On Target Laboratories Inc
Principal Investigator: Teresa Diaz-Montes, M.D., 410-332-9250, Armando Sardi, M.D., 410-332-9294
Research Coordinator: Michelle Sittig, RN, 410-332-9294
For More Information: 410-332-9294 or msittig@mdmercy.com
Coordinated Through: The Gynecologic Oncology Center at Mercy and Surgical Oncology at Mercy

The Phase 3 study is to confirm the efficacy of OTL38 in combination with fluorescent light to detect additional Folate Receptor-positive (FR+) ovarian cancer lesions not detected by palpation and visualization under normal light in patients with FR+ ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery. (Clinicaltrials.gov ID#: NCT03180307)

AURORA

Topic of Study: Gastrointestinal Disease
Sponsor: Tobira Therapeutics
Principal Investigator: Paul Thuluvath, M.D., FRCP, 410-332-9356
Research Coordinator: Sung Cho, 410-576-5389
For More Information: scho@mdmercy.com
Coordinated Through: The Institute for Digestive Health and Liver Disease

This study is a phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of cenicriviroc for the treatment of liver fibrosis in adult subjects with nonalcoholic steatohepatitis. (AURORA)

BO40747

Topic of Study: Breast Cancer
Sponsor: F HoffmanLa Roche
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer (Clinicaltrials.gov ID#: NCT03726879).

BIG 16-05/AFT-27/WO39391

Topic of Study: Breast Cancer
Sponsor: F HoffmanLa Roche
Principal Investigator: David Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a research study comparing Atezolizumab (Anti-PD-L1 antibody) in combination with adjuvant anthracycline/taxane-based chemotherapy versus chemotherapy alone in patients with operable triplenegative breast cancer. (Clinicaltrials.gov ID#: NCT03498716)

BWEL

Topic of Study: Breast Cancer
Sponsor: Alliance for Clinical Trials in Oncology
Principal Investigator: David A. Riseberg, MD, 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). This study will help to show whether weight loss programs should be a part of breast cancer treatment. (Clinicaltrials.gov ID#: NCT02750826)

BYLIEVE

Topic of Study: Breast Cancer
Sponsor: Novartis Pharmaceuticals Corporation
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a phase II randomized trial evaluate the efficacy and Safety of alpelisib plus fulvestrant or letrozole in patients with PIK3CA mutant, hormone receptor (HR) positive, HER2- negative advanced breast cancer (aBC), who have progressed on or after CDK 4/6 inhibitor treatment. (Clinicaltrials.gov ID#: NCT03056755)

CO40016

Topic of Study: Breast Cancer
Sponsor: F HoffmanLa Roche
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a double-blind, placebo-controlled, randomized phase III study of ipatasertib in combination with paclitaxel as a treatment for patients with PIK3CA/AKT1/PTEN-altered, locally advanced or metastatic, triple-negative breast cancer or hormone receptor–positive, HER2-negative breast cancer  (Clinicaltrials.gov ID#: NCT03337724).

DESTINY

Topic of Study: Breast Cancer
Sponsor: Daiichi Sankyo Inc
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This trial compares DS-8201a, an anti-HER2-antibody drug conjugate, versus standard of care for HER2-positive, unresectable and/or metastatic breast cancer subjects pretreated with prior standard of care HER2 therapies, including T-DM1. (ClinicalTrials.gov ID#: NCT03523585)


EA1131

Topic of Study: Breast Cancer
Sponsor: ECOG ACRIN Cancer Research Group
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a phase III trial to determine how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with triple-negative breast cancer who have residual disease following neoadjuvant chemotherapy and surgery. (Clinicaltrials.gov ID#: NCT02445391)

EMERALD

Topic of Study: Breast Cancer
Sponsor: Radius Pharmaceuticals Inc
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This trial compares the efficacy and safety of elacestrant to the standard of care fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on at least one endocrine therapy. (ClinicalTrials.gov ID#: NCT03778931)


A Single Arm Prospective Multicenter Study Evaluating the Biodesign® Plastic Surgery Matrix

Topic of Study: Breast Cancer
Sponsor: Cook Biotech Incorporated
Principal Investigator: Brendan J. Collins, M.D., 401-332-9700
Research Coordinator: Irene van Gaalen, PA-C, 410-332-5488
For More Information: 410-951-7950
Coordinated Through: The Breast Reconstruction and Restoration Center at Mercy

This study is designed for patients desiring nipple reconstruction following surgery for breast cancer and breast reconstruction. Eligible patients will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK® Biodesign® Plastic Surgery Matrix. The study is designed to evaluate the benefit of this device in achieving effective and aesthetic nipple reconstruction. Patients will be evaluated at the time of the procedure and at 1 week, 4 weeks, 3 months, 6 months, and 12 months after surgery to examine the projection of their reconstructed nipple(s) and patient satisfaction (Cook Medical Study 09-009; Clinicaltrials.gov ID#: NCT01216319).

FLEX

Topic of Study: Breast Cancer
Sponsor: Agendia
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

The purpose of this registry is to create a large-scale, population-based database. This database will match health information to genome information to look at the Agendia Breast Cancer suite and new gene associations. The Agendia Breast Cancer Suite includes MammaPrint® and BluePrint™, which are tests that help your doctor analyze and profile your breast cancer tumor. DiscoverPrint is for research purposes only. (Clinicaltrials.gov ID#: NCT03053193)

Insulin

Topic of Study: Breast Cancer
Sponsor: Mt Sinai NY
Principal Investigator: Neil B. Friedman, M.D., 410-332-9330
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459 and Andrea Gerbasio CRA, 410-951-7908
For More Information: 410-951-7950
Coordinated Through: Institutional Research

This study is researching the link between insulin resistance and breast cancer prognosis in African American and Caucasian women.

NATALEE

Topic of Study: Breast Cancer
Sponsor: Novartis Pharmaceuticals Corporation
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (Clinicaltrials.gov ID#: NCT03701334).

NEULASTA ONPRO

Topic of Study: Febrile Neutropenia
Sponsor: Amgen
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a prospective observational study to estimate the incidence of febrile neutropenia among subjects with non-myeloid malignancies at high risk for febrile neutropenia and receiving Neulasta® (Pegfilgrastim) Onpro® kit or other physician choice options for prophylaxis of febrile neutropenia.

 

Observational Study to Define the Microbiologic and Immune Characteristics of Peritoneal Tissues in Patients with Appendiceal Cancer with Peritoneal Spread

Topic of Study: Appendiceal Cancer
Principal Investigator: Armando Sardi, MD, FACS, 410-332-9294
Research Coordinator: Michelle Sittig, RN, 410-783-5828
For More Information: 410-332-9294
Coordinated Through: Surgical Oncology at Mercy

The primary aim of the study is to determine the microbiological environment of the peritoneal tissues of patients undergoing cytoreductive surgery with intraoperative hyperthermic chemotherapy for appendix cancer with peritoneal spread.

Ovarian, Fallopian Tube, and Primary Peritoneal Cancers

Topic of Study: Gynecologic Cancer
Principal Investigator: Teresa Diaz-Montes, M.D., 410-332-9250, Armando Sardi, M.D., 410-332-9294
Research Coordinator: Michelle Sittig, RN, 410-332-9294
For More Information: 410-332-9329 or 410-332-9294
Coordinated Through: The Gynecologic Oncology Center at Mercy and Surgical Oncology at Mercy

The purpose of this phase II trial is to determine the toxicity and post-operative complications related to cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) as an initial treatment option for patients with ovarian, fallopian tube, or primary peritoneal cancers and its impact on quality of life.  Subjects will be randomized to one of two treatment groups: CRS with HIPEC followed by combination chemotherapy, carboplatin and paclitaxel, or CRS only followed by combination chemotherapy carboplatin and paclitaxel.

Protocol Title and ClinicalTrials ID#: A phase II randomized study: Outcomes after cytoreductive surgery (CRS) with or without carboplatin hyperthermic intraperitoneal chemotherapy (HIPEC) followed by systemic chemotherapy with carboplatin and paclitaxel as initial treatment of ovarian, fallopian tube, and primary peritoneal cancer. NCT02124421

Development of Patient-derived Tumorgrafts as a Model for the Discovery of Biomarkers and Therapeutic Approaches for Gynecological Tumors

Topic of Study: Gynecologic Cancer
Principal Investigator: Teresa Diaz-Montes, M.D., 410-332-9250
Research Coordinator: Michelle Sittig, RN or Angie Gahres, BSN, RN at 410-332-9294
For More Information: 410-332-9294
Coordinated Through: The Gynecologic Oncology Center at Mercy and Johns Hopkins University, Oncology - Cancer Prevention and Control

The objective of this study is to collect patient specimens prospectively (tumor, blood, vaginal swab, and urine sample) from benign, high risk, and malignant surgeries in order to develop diagnostic biomarkers and targeted anticancer agents for gynecologic tumors. http://lifegenedna.com/

Clinical Trial to Define the Effect of Perioperative H. Pylori Eradication with Antibiotic Treatment on the Long Term Outcomes of Patients with Pseudomyxoma Peritonei of appendiceal origin undergoing Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy (CRS/HIPEC)

Topic of Study: Appendiceal Cancer
Principal Investigator: Armando Sardi, M.D., 410-332-9294
Research Coordinator: Michelle Sittig, RN, 410-332-9294
For More Information: 410-332-9294
Coordinated Through: Surgical Oncology at Mercy

This study is a phase II, open label, historical controlled study to determine the impact of antibiotic therapy on the disease progression and overall survival of the patients with Pseudomyxoma Peritonei (PMP). The study will examine the use of the antibiotic PREVPAC, in patients undergoing CRS/HIPEC for appendiceal neoplasms with peritoneal dissemination and its effect on patient outcomes and survival. (ClinicalTrials.gov ID#: NCT02387203)


A Study of Histo-Pathological Staging and Classification Guidelines for Appendiceal Carcinomatosis

Topic of Study: Appendiceal Cancer
Principal Investigator: Armando Sardi, M.D. 410-332-9294, Kimberley Studeman, M.D. 410-332-9447
Research Coordinator: Michelle Sittig, RN, 410-332-9294
For More Information: 410-332-9294
Coordinated Through: Surgical Oncology at Mercy

This is a study to define the pathological staging for appendiceal neoplasms by examining mutations of the genetic makeup of tumor tissue and to analyze prognostic factors associated with various stages of appendiceal cancer with peritoneal dissemination.  


POLARIS

Topic of Study: Breast Cancer
Sponsor: Pfizer
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a non-interventional trial for patients receiving palbociclib for their hormone positive advanced breast cancer.  (Clinicaltrials.gov ID#: NCT03280303)

 

SWOG S1418

Topic of Study: Breast Cancer
Sponsor: Southwest Oncology Group
Principal Investigator: David A. Riseberg, M.D., 410-783-5858
Research Coordinator: Lisa McConnell, RN, 410-332-1200; Sarah Ruff, RN, 410-332-9459; Alexandra Cline, RN, 410-951-7956
Coordinated Through: Institutional Research

This is a phase III randomized trial evaluate the efficacy and safety of pembrolizumab for women with triple-negative breast cancer who have residual invasive cancer or positive lymph nodes after neoadjuvant chemotherapy. (Clinicaltrials.gov ID#: NCT02954874)

TARGIT-US

Topic of Study: Breast Cancer
Sponsor: University of California San Francisco
Principal Investigator: Neil B. Friedman, MD, 410-332-9330
Study Coordinator: Andrea Gerbasio, 410-951-7908
For More Information: 410-951-7950
Coordinated Through: Institutional Research

This is an observational study for women who are receiving Intraoperative Radiation Therapy (IORT) following breast-conserving surgery. (ClinicalTrials.gov ID#: NCT01570998)

Hyperthermic Intraoperative Intraperitoneal Chemotherapy for Intra-abdominally Advanced Colorectal, Appendix, Gastric, Small Bowel, Primary Peritoneal, Ovarian Cancers, Peritoneal Mesothelioma, and Sarcomas

Topic of Study: Other
Principal Investigator: Armando Sardi, M.D. and Vadim Gushchin, M.D., 410-332-9294
Research Coordinator: Michelle Sittig, RN, 410-332-9294
For More Information: 410-332-9294
Coordinated Through: Surgical Oncology at Mercy

This study involves storing specimens from CRS/HIPEC patients with advanced colorectal, gastric, small bowel, primary peritoneal, ovarian cancers, peritoneal mesothelioma, and sarcomas. The purpose is to collect, maintain, and store tissues specimens from CRS/HIPEC and clinical data for future research. The collection of clinical data and outcomes from CRS/HIPEC for advanced intra-abdominal cancers will be used to refine future treatment protocols and enhance patient care.

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