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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) 

Injection of Bromelain and Acetylcysteine in Combination into Recurrent Mucinous Tumor or Pseudomyxoma Peritonei: A Phase I/II International, Multi-center Study

Topic of Study: Mucinous Tumors or Pseudomyxoma Peritonei
Sponsor: Mucpharm Pty Ltd
Principal Investigator: David L Morris, MD, PhD (University of New South Wales), Armando Sardi, MD (Mercy Medical Center) 410-332-9294
Research Coordinator: Michelle Sittig, RN 410-332-9294, msittig@mdmercy.com
Coordinated Through: Department of Surgical Oncology, The Institute for Cancer Care at Mercy

This study involves patients with mucinous peritoneal tumors, including pseudomyxoma peritonei (PMP), who are not candidates for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) or other potentially beneficial surgery.

An interventional radiologist will insert a percutaneous drain. The combination drug treatment of bromelain and acetylcysteine will be injected directly into the tumor or peritoneal cavity via drain and dwell for 24 hours. The aspiration/drainage and repeat drug treatments will be delivered via this drain. The dose of the drug is dependent on the calculated tumor dimensions and volume outlined in the protocol.

The expectation is that the drug combination will dissolve the tumor, allowing it to be drained. Remaining mucinous tumor that is unable to be drained will be considered for repeat drug treatments.

Clinicaltrials.gov: NCT03976973

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

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.  


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.

Meet Our Doctors: Surgical Oncology
Dr. Vadim Gushchin - Surgical Oncology at Mercy - Baltimore
Vadim Gushchin, M.D.

Dr. Vadim Gushchin is Director of The Melanoma and Skin Cancer Center at Mercy as well as Director of Gastrointestinal Oncology. He is a skilled cancer surgeon offering expertise in gastrointestinal malignancies as well as advanced treatment options including HIPEC and robotic surgery.

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