BREAST SURGERY | COLORETAL SURGERY | ENDOCRINE SURGERY | PANCREATIC SURGERY | PLASTIC SURGERY
THORACIC SURGERY |

BREAST SURGERY:

A011104: Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women with Breast Cancer
Aims: The purpose of this study is to test whether patients undergoing a breast MRI (magnetic resonance imaging) before breast surgery will have better results after the surgery.  Breast tumors are routinely evaluated using mammograms and ultrasound before surgery.  This study would like to find out if using MRI in addition to mammography before surgery improves our ability to evaluate tumors and decide what kind of surgery is best for the patient.
Diagnosis: Breast Cancer,Clinical Stage I - II
Principal Investigator: Katharine Yao, MD
IRB Approval Number: EH14-346
Sponsor: Alliance for Clinical Trials in Oncology
Contact: Interested patients may contact Marna Burright, RN at 847.570.1697, mburright@northshore.org or Sarah Rabbitt, RN at 847.570.1681 srabbitt@northshore.org   
Open to Enrollment: Yes 

Improved MRI images of High Risk Breast Lesions
Aims: The purpose of the study is to determine whether the use of breast MRI in patients with high-risk breast lesions can help us identify patients who have high-risk lesions that could have been managed with surveillance rather than surgical excision.
Diagnosis: Breast Cancer
Principal Investigator: Katharine Yao, MD
IRB Approval Number: EH12-014
Sponsor: NorthShore University HealthSystem
Contact: Interested patients may contact Mary Turk, CTR, CCRP at 847.570.1184, mturk@northshore.org or Sarah Rabbitt, RN, CCRP at 847.570.1681 srabbitt@northshore.org
Open to Enrollment: Yes

Phase II Study of Neoadjuvant Letrozole for Post-Menopausal Women with Estrogen Receptor Positive Ductal Carcinoma In Situ (DCIS)
Aims: The purpose of this study is to test whether neoadjuvant (meaning given before surgery) treatment with aromatase inhibitor (anti-hormonal medication) called Letrozole has an effect, either good or bad, on you and on the DCIS. Mammograms are the standard method of detecting and measuring DCIS. In this study, we would also like to learn more about whether Magnetic Resonance Imaging (MRI) may be better for evaluating and measuring DCIS when compared to mammograms.
Diagnosis: Breast Cancer
Principal Investigator: Katharine Yao, MD
IRB Approval Number: EH13-408
Sponsor: Cancer and Leukemia Group B
Contact: Interested patients may contact Sarah Rabbitt, RN, CCRP at 847.570.1681, srabbitt@northshore.org
Open to Enrollment: Yes

Piloting an In-Visit Decision Aid for Surgical Decision Making In Breast Cancer Patients
Aims: The purpose of this study is to develop a decision aid that can be used by surgeons to help patients decide which surgical procedure to choose for their newly diagnosed breast cancer. Additionally, we would like to learn more about a patient’s knowledge about breast cancer and the treatment for it and what affects a woman’s decision when making her choice for surgery.
Diagnosis: Breast Cancer
Principal Investigator: Katharine Yao, MD
IRB Approval Number: EH14-020
Sponsor: Alliance for Clinical Trials in Oncology
Contact: Interested patients may contact Sarah Rabbitt, RN, CCRP at 847.570.1681, srabbitt@northshore.org
Open to Enrollment: Yes

The Establishment and Maintenance of the NorthShore University HealthSystem Comprehensive Data Registry for Breast Surgeries and Breast Tissue Bank
Aims: The purpose of this study is to collect information and left over breast tissue from patients with breast surgery to help learn about breast cancer prevention, early detection of breast cancer and what kinds of breast cancer treatment are most beneficial. In addition, information about the surgical outcomes of cosmetic and reconstructive breast surgery will be collected.
Diagnosis: Breast Cancer & Benign Breast Conditions
Principal Investigator: Katharine Yao, MD
IRB Approval Number: EH88-077
Sponsor: NorthShore University HealthSystem
Contact: Interested patients may contact Mary Turk, CTR, CCRP at 847.570.1184, mturk@northshore.org
Open to Enrollment: Yes

Development and Maintenance of a Comprehensive Breast Reconstruction Registry at NorthShore University HealthSystem
Aims: To track long-term satisfaction following breast reconstruction.
Diagnosis: Breast cancer. Participants must enroll prior to breast reconstruction surgery.
Principal Investigator: Mark Sisco, MD
IRB Approval Number: EH11-124
Sponsor: NorthShore University HealthSystem
Contact: Interested patients may contact Agnes Brugger, RN, CCRP 847.570.1632, kbrugger@northshore.org
Open to Enrollment: Yes

The NorthShore Study of Surgical Decision-Making and Quality of Life Outcomes after Breast Cancer Surgery
Aims: To discover the decision-making pathway in newly diagnosed breast cancer patients.
Diagnosis: Breast cancer. Participants must enroll prior to breast surgery.
Principal Investigator: Mark Sisco, MD
IRB Approval Number: EH14-218
Sponsor: NorthShore University HealthSystem
Contact: Interested patients may contact Agnes Brugger, RN, CCRP 847.570.1632, kbrugger@northshore.org
Open to Enrollment: Yes

COLORECTAL SURGERY:

N1048: A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision (PROSPECT)
Aims: The primary aim of the study is to assure that use of pre-operative chemotherapy followed by selected use of chemotherapy with radiation is equally as effective as the standard treatment of chemotherapy with radiation pre-operatively. The second aim is to determine if the response to either treatment results in complete regression of the tumor as demonstrated at time of surgery. Patients would possibly avoid radiation in the investigative arm of the study depending on the tumor’s response to treatment.
Diagnosis: Locally Advanced Rectal Cancer: Stages IIA- IIIB
Principal Investigator: Joseph Muldoon, MD
IRB Approval Number: EH12-468
Sponsor: Alliance for Clinical Trials in Oncology
Contact: Interested patients may contact Claudia Fredian, RN, OCN, CCRP at 847.570.1512, cfredian@northshore.org
Open to Enrollment: Yes

Defining the Role of Microbes in the Pathogenesis of Intestinal Anastomotic Leak Via Serial Endoscopic Surveillance
Aims: To evaluate the safety and feasibility of performing repeated limited sigmoidoscopy, termed serial endoscopic surveillance (SES), in ten (10) patients in the post-operative period of surgical recovery following a low anterior resection (LAR) and loop ileostomy, a standard procedure for rectal cancer.  The study will examine intestinal bacterial composition and function to healing and the risk of anastomotic leak (leak at the site of surgical connection).
Diagnosis: Colorectal Cancer
Principal Investigator: Joseph Muldoon, MD
IRB Approval Number: EH14-272
Sponsor: American Society of Colon and Rectal Surgeons (ASCRS) Research Foundation in collaboration with the University of Chicago
Contact: Interested participants may contact the Jen Jaffe, MPH, CCRP at 847.570.2803, jjaffe@northshore.org
Open to Enrollment: Yes

ENDOCRINE SURGERY:

The Establishment of a Multi-Disciplinary Comprehensive Database of Patients for Thyroid Nodular Disorders
Aims: To investigate the presentation, diagnosis, and treatment of thyroid nodular disorders to improve diagnostic and treatment modalities.
Diagnosis: Thyroid Nodule, Thyroid Mass, Goiter, Thyroid Cancer
Principal Investigator: Tricia Moo-Young, MD
IRB Approval Number: EH14-058
Sponsor:  NorthShore University HealthSystem
Contact:  Interested patients may contact Patty Park at 847.570.1675, ppark@northshore.org
Open to Enrollment: Yes

Epigenetic Chromatin Conformation Changes in Peripheral Blood to Differentiate Benign versus Malignant Thyroid Lesions
Aims: To investigate the existence of epigenetic biomarkers for thyroid cancer, while testing the efficacy of new analytical biomarker technology.
Diagnosis: Thyroid Cancer, Benign thyroid nodule, Follicular lesion of undetermined significance (FLUS)/ Atypia of undetermined significance (AUS)
Principal Investigator: Richard Prinz, MD
IRB Approval Number: EH14-263
Sponsor: NorthShore University HealthSystem
Contact: Interested patients may contact Patty Park at 847.570.1675, ppark@northshore.org
Open to Enrollment: Yes

PANCREATIC SURGERY:

Clinical Pancreatic Cancer Database
Aims: Capture, review, and compare medical information, including symptoms, treatments and complications that people with pancreatic diseases have and store this information for future research studies.
Diagnosis: Any pancreatic disease
Principal Investigator: Mark S. Talamonti, MD
IRB Approval Number: EH08-197T
Sponsor: NorthShore University HealthSystem
Contact: Interested patients may contact Susan Jane Stocker, LPN, BLS, CCRP at 847.570.1322, sstocker@northshore.org; or Gnathan Carpenter, RN at 847.570.2949, gcarpenter@northshore.org
Open to Enrollment: Yes

The Pancreatic Sample Repository
Aims: Collect blood, pancreatic secretions and pancreatic tissue from patients undergoing surgery for pancreatic diseases, including cancer and store these samples in a repository for future studies done at NorthShore or at collaborating institutions.
Diagnosis: Any pancreatic disease (undergoing surgery)
Principal Investigator: Karen Kaul, MD
IRB Approval Number: EH02-186
Sponsor: NorthShore University HealthSystem
Contact: Interested patients may contact Susan Jane Stocker, LPN, BLS, CCRP at 847.570.1322, sstocker@northshore.org; or Gnathan Carpenter, RN at 847.570.2949, gcarpenter@northshore.org
Open to Enrollment: Yes

Comprehensive Assessments for Clinical Care and Surgical Management Among Individuals with Pancreatic Pathology
Aims: Identify why some patients do better than others after pancreatic surgery by looking at the health and feelings of patients before and after the surgery. We aim to learn why some patients are more likely to develop problems related to surgery or take longer to recover and what may protect them and help them recover well.
Diagnosis: Any pancreatic disease (undergoing pancreatic resection surgery)
Principal Investigator: Mark S. Talamonti, MD
IRB Approval Number: EH13-433
Sponsor: NorthShore University HealthSystem
Contact: Interested patients may contact Gnathan Carpenter, RN at 847.570.2949, gcarpenter@northshore.org or Susan Jane Stocker, LPN, BLS, CCRP at 847.570.1322, sstocker@northshore.org


PLASTIC SURGERY:

Creation of a Tissue Repository for Biological Samples from Congenital Nevi and Other Neurocristopathies
Aims: Tissue banking study to gather specimens for other research.
Diagnosis: Large or Giant Congenital Melanocytic Nevus
Principal Investigator: Bruce S. Bauer, MD
IRB Approval Number: EH11-114
Sponsor:  NorthShore University HealthSystem
Contact:  Interested patients may contact Agnes Brugger, RN, CCRP 847.570.1632, kbrugger@northshore.org
Open to Enrollment:  Yes

Defining the Unique Skin and Blood Biomarkers of Pediatric Atopic Dermatitis: Sub-Contract
Aims: To collect non-diseased (control) tissue for a study of pediatric atopic dermatitis (eczema).
Diagnosis: None
Principal Investigator: Bruce S. Bauer, MD
IRB Approval Number: EH13-297
Sponsor: NorthShore University HealthSystem
Contact: Interested patients may contact Agnes Brugger, RN, CCRP 847.570.1632, kbrugger@northshore.org
Open to Enrollment: Yes

THORACIC SURGERY:

The Establishment and Maintenance of a Comprehensive Thoracic Tumor Data Registry and Biorepository
Aims: The purpose of this database is to allow researchers to review and compare medical information including medical history, symptoms, medical test results, treatments and complications that people with thoracic tumor may have.  Another purpose of this study is to collect leftover tissue obtained during thoracic surgery or diagnostic tests. Research testing of this tissue may help to determine the changes which lead to the development and/or spread of cancer. This information may help to develop new kinds of diagnostic tests and treatment for thoracic cancer. This study will include approximately 300 subjects a year from NorthShore University HealthSystem.
Diagnosis: Lung Cancer, Esophageal Cancer, Thymic Cancer, Thymoma, Mesothelioma
Principal Investigator: John Howington, MD
IRB Approval Number: EH98-136
Sponsor: NorthShore University HealthSystem
Contact: Interested participants may contact Ujala Bokhary, MBBS, CCRP at 847.570.1783, ubokhary@northshore.org
Open to Enrollment: Yes

CALGB 140503: A Phase III Randomized Trial of Lobectomy versus Sublobar Resection for Small (≤ 2 cm) Peripheral Non-Small Cell Lung Cancer
Aims: The primary aim of this study is to determine if removing a smaller portion of the lung around the tumor is equal to the standard removal of the entire lobe in keeping the cancer from returning.
Diagnosis: Non-small cell lung cancer (NSCLC) with tumor less than or equal to 2cm
Principal Investigator: John Howington, MD
IRB Approval Number: EH12-430
Sponsor: Alliance for Clinical Trials in Oncology
Contact: Interested patients may contact Claudia Fredian, RN, OCN, CCRP at 847.570.1512, cfredian@northshore.org
Open to Enrollment: Yes

A151216:Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
Aims: This study is being done to determine if patients with Non-Small Cell Lung Cancer (NSCLC) have a mutation (abnormal change) in the DNA of their tumor and if so, which one. Two genes are being assessed: EGFR and ALK. Not all NSCLC tumors have a change in these genes. This study will lead into the two treatment trials which will target the specific gene with specific drugs. Tissue from the tumor removed at the time of surgery is sent to a national laboratory to be analyzed and compared to the local results.
Diagnosis: Non-Small Cell Lung Cancer (NSCLC) Stages IB, II, IIIA
Principal Investigator: John Howington, MD
IRB Approval Number: EH15-122
Sponsor: Alliance for Clinical Trials in Oncology
Contact: Interested patients may contact Claudia Fredian, RN, OCN, CCRP at 847.570.1512, cfredian@northshore.org
Open to Enrollment: Yes

A081105: 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)
Aims: The goal of this study is to find out whether treatment with erlotinib will result in improved survival over placebo for patients with Stage IB -IIIA NSCLC who have an EGFR mutation following complete resection and standard post-operative therapy. This study is the treatment trial linked to A151216 Alchemist trial where the tissue is sent for determination of gene mutations post operatively.
Diagnosis: Non-Small Cell Lung Cancer (NSCLC) Stages IB, II, IIIA
Principal Investigator: John Howington, MD
IRB Approval Number: EH15-121
Sponsor: Alliance for Clinical Trials in Oncology
Contact: Interested patients may contact Claudia Fredian, RN, OCN, CCRP at 847.570.1512, cfredian@northshore.org
Open to Enrollment: Yes

E4512: 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
Aims: The goal of this study is to find out whether treatment with crizotinib will result in improved survival over placebo for patients with Stage IB -IIIA NSCLC who have an ALK mutation following complete resection and standard post-operative therapy. This study is the treatment trial linked to A151216 Alchemist trial where the tissue is sent for determination of gene mutations post operatively.
Diagnosis: Non-Small Cell Lung Cancer (NSCLC) Stages IB, II, IIIA
Principal Investigator: John Howington, MD
IRB Approval Number: EH15-123
Sponsor: Alliance for Clinical Trials in Oncology
Contact: Interested patients may contact Claudia Fredian, RN, OCN, CCRP at 847.570.1512, cfredian@northshore.org
Open to Enrollment: Yes

A Multicenter, Randomized Trial of Esophagectomy and Cervical Esophagogastrostomy With (Two-stage) or Without (One-stage) Prior Ischemic Gastric Conditioning by Laparoscopic Ligation of Left Gastric and Short Gastric Arteries
Aims: The study aims to determine if ischemic gastric preconditioning by cutting part of the blood supply to the stomach several days before the esophagectomy procedure minimizes side effects.  It will also examine if there is a difference in the quality of life (QOL) of patients in two arms of the study as assessed by validated questionnaires.
Diagnosis: Surgical candidates for esophageal cancer
Principal Investigator: Ki Wan Kim, MD
IRB Approval Number: EH15-175
Sponsor: NorthShore University HealthSystem
Contact: Interested patients may contact Jen Jaffe, MPH, CCRP at 847.570.2803, jjaffe@northshore.org or Ujala Bokhary, MBBS, CCRP at 847.570.1783, ubokhary@northshore.org 
Open to Enrollment: Yes

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