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Clinical
Trials

We conduct many clinical trials that evaluate the effectiveness and safety of emerging technologies, medicines, treatments and therapies. Our patients benefit by having access to some of the latest approaches and treatments for serious or challenging medical conditions—without having to leave the community. All of our studies are overseen by an Institutional Review Board (IRB) to ensure the highest standards of human subjects protection are always followed.

For more information about these studies call 847-618-4358.

Open Clinical Trials

NanoKnife System

Registry to Evaluate the Effectiveness and Safety of the NanoKnife System for the Ablation of Stage 3 Pancreatic Adenocarcinoma

Principal Investigator: Dr. Malcom Bilimoria

Study Overview: The purpose of this study is to evaluate the effectiveness and safety of the NanoKnife System for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC) compared to standard of care alone.

IRB Number:
NCH19-08/EH22-351E

Enrollment Status:
Enrolling

For more information, please click on the following link which will take you to the study site on clinicaltrials.gov:

GI Surgical Database Study

Principal Investigator: Dr. Malcolm Bilimoria

Study Overview: The purpose of this study is simply to gather information on patients that are diagnosed with various conditions that are treated surgically. The information could then be used to track trends in diagnosing and treating these conditions, and possibly for research studies in the future.

IRB Number:
NCH09-07/EH22-420

Enrollment Status:
Enrolling

Translational Oncology

Discovery and Evaluation of Biomarkers/Pharmacogenomics for the Diagnosis and Personalized Management of the Cancer Patient (MTG-015)

Principal Investigator: Dr. Malcom Bilimoria

Study Overview: The purpose of this research is to collect and store blood samples to provide to researchers who are trying to develop new drugs, treatments, or tests, as well as study how individual differences may affect how drugs work.

IRB Number:
NCH09-21/EH22-296E

Enrollment Status:
Enrolling

Alliance A021806 Study

A Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer.

Principal Investigator: Dr. Malcom Bilimoria

Study Overview: To evaluate and compare overall survival (OS) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

IRB Number:
EH22-071

Enrollment Status:
Pending Enrollment

Translational Oncology

Discovery and Evaluation of Biomarkers/Pharmacogenomics for the Diagnosis and Personalized Management of the GI Disorder Patient (MTG-022)

Principal Investigator: Scott N Pinchot, MD

Study Overview: The purpose of this research is to collect and store blood samples to provide to researchers who are trying to develop new drugs, treatments, or tests, as well as study how individual differences may affect how drugs work.

IRB Number:
NCH19-07/EH22-294E

Enrollment Status:
Enrolling

Translational Medicine

Discovery and Evaluation of Biomarkers/Pharmacogenomics for the Diagnosis and Personalized Management of Patients (MTG-022)

Principal Investigator: Marina Messinger, MD

Study Overview: The purpose of this research is to collect and store blood samples to provide to researchers who are trying to develop new drugs, treatments, or tests, as well as study how individual differences may affect how drugs work.

IRB Number:
NCH20-12/EH22-295E

Enrollment Status:
Enrolling

PROPHETIC

PROPHETIC – Predicting responsiveness in oncology patients based on host response evaluation during anti-cancer treatments

Principal Investigator: Marina Messinger, MD

Study Overview: The goal of this research study is to develop an algorithm that predicts the patient’s treatment outcome. This algorithm will serve as a tool for physicians when making treatment decisions, specifically for stage IV NSCLC and malignant melanoma patients receiving anti-cancer treatments. The investigators also aim to identify the metabolic pathways that could lead to better therapeutic options. The patients will be given their treatment according to the institute’s standard of care. The patients will provide two blood samples and clinical data will be collected from their medical records.

IRB Number:
NCH20-21/EH22-457

Enrollment Status:
Enrolling

For more information, please click on the following link which will take you to the study site on clinicaltrials.gov:

Oral Care

The Role of Oral Care in Non-Ventilator Hospital-Acquired Pneumonia (NVHAP) Pneumonia

Principal Investigator: Dian Baker, PhD, RN & Karen K. Giuliano, PhD, RN

Study Overview: The purpose of this study is to determine the effectiveness of a universal, standardized oral care protocol on prevention of non-ventilated hospital-acquired pneumonia (NVHAP) in the acute care setting.

IRB Number:
EH22-266

Project Manager:
Jackolyn Gayden

Primary Contact Information:
jgayden@nch.org

Enrollment Status:
Active study

COMPASSHER2 Breast Cancer Trial

The COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib

Principal Investigator: Dr. Urszula Sobol

Study Overview: The purpose of this study is to look at the effectiveness of chemotherapy treatment (T-DM1 and Tucatinib) compared with the control (T-DM1 and placebo) in patients 18 years and older with HER2 positive residual disease breast cancer patients.

IRB Number:
EH22-001

Enrollment Status:
Enrolling

Institutional Review Board (IRB)

Effective November 22, 2021 the transition to NS IRB was initiated and all new studies are being submitted to the NS IRB as of this date.

Their IRB is a multidisciplinary team of medical professionals and community members that review all applicable research performed at the hospital from the perspective of human subject protection.

Their mission is to protect the rights, privacy and safety of patients who participate in research at the hospital. We achieve this by ensuring that all protocols approved are of the highest level of integrity as we all comply with federal government regulations and guidelines.

IRB ORGANIZATION AND FEDERALWIDE ASSURANCE

The NCH IRB and its board are still registered in the Office for Human Research Protections (OHRP) Database. To confirm, you can use the following information:

  • NCH’s IRB Office Organization number is IORG0002660
  • NCH’s IRB FWA number is FWA00004329

We offer additional information about becoming an investigator or co-investigator in a clinical trial at NCH.

NCH IRB Policies and Procedures which govern clinical research have transitioned to the NorthShore Legacy IRB policies and can be made available upon request by contracting the research office.