BREAST SURGERY | COLORECTAL SURGERY | ENDOCRINE SURGERY |MINIMALLY INVASIVE SURGERY PANCREATIC SURGERY | PLASTIC SURGERYTHORACIC 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 Sarah Rabbitt, RN, CCRP at 847.570.1681, srabbitt@northshore.org   
Open to Enrollment: Yes 

A011202: A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinal Lymph Node Disease After Neoadjuvant Chemotherapy 
Aims: This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.
Diagnosis: Breast Cancer, Clinical Stage II - IIIA
Principal Investigator: Catherine Pesce, MD
IRB Approval Number: EH15-297
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 

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 Jen Jaffe, MPH, CCRP 847.570.2803, jjaffe@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 Jennifer Jaffe, MPH, CCRP 847.570.2803, jjaffe@northshore.org
Open to Enrollment: Yes

Using Genetic Risk Scores to Assess the Efficacy of Mammography Screening Among Women Diagnosed with Breast Cancer
Aims: This study is looking at whether one’s Genetic Risk Score (GRS) along with other risk factors will aid in identification of a subgroup of women at high risk for breast cancer in need for increased surveillance.
Diagnosis: Breast Cancer
Principal Investigator: Catherine Pesce, MD
IRB Approval Number: EH15-308
Sponsor: NorthShore University HealthSystem
Contact: Interested patients may contact Sarah Rabbitt, RN, CCRP at 847.570.1681, srabbitt@northshore.org or Sandra Simovic at 847.570.4227, ssimovic@northshore.org
Open to Enrollment: Yes

Germline Genetic Profiles Associated with Contralateral Breast Cancer Patients
Aims: To determine whether or not women diagnosed with contralateral breast cancer have higher incidences of known breast cancer risk-associated genetic alterations.
Diagnosis: Breast Cancer
Principal Investigator: Katharine Yao, MD
IRB Approval Number: EH16-063
Sponsor: NorthShore University HealthSystem
Contact: Interested patients may contact Sandra Simovic at 847.570.4227 ssimovic@northshore.org or Sarah Rabbitt, RN, CCRP at 847.570.1681, srabbitt@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

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

MINIMALLY INVASIVE SURGERY:

The Establishment and Maintenance of a Comprehensive Data Registry for NorthShore University HealthSystem Bariatric Surgical Services
Aims: Capture, review, and compare medical information, including symptoms, treatments and complications that people with bariatric surgery have and store this information for future research studies
Diagnosis: Obesity
Principal Investigator: Woody Denham, MD
IRB Approval Number: EH05-073

A Comprehensive Database for Patients Diagnosed with a Hernia
Aims: Capture, review, and compare medical information, including symptoms, treatments and complications that people with hernias have and store this information for future research studies
Diagnosis: Hernia
Principal Investigator: Michael Ujiki, MD
IRB Approval Number: EH10-113

A Comprehensive Gastro-Esophageal Database
Aims: Capture, review, and compare medical information, including symptoms, treatments and complications that people with gastro-esophageal diseases have and store this information for future research studies
Diagnosis: Gastro-esophageal disease
Principal Investigator: Michael Ujiki, MD
IRB Approval Number: EH11-148

Per-Oral Endoscopic Myotomy
Aims: To perform surgical treatment of motility disorders via endoscopic myotomy and follow longterm outcomes
Diagnosis: Esophageal motility disorder
Principal Investigator: Michael Ujiki, MD
IRB Approval Number: EH13-029
Contact: Interested patients may contact JoAnn Carbray at 847-570-3802, jcarbray@northshore.org

A Randomized Controlled Study of Self Fixating Mesh Versus Non Fixating Polyester Mesh for Laparoscopic Inguinal Hernia Repair
Aims: Comparing two types of mesh for inguinal hernia repair
Diagnosis: Inguinal hernia
Principal Investigator: John Linn, MD
IRB Approval Number: EH13-356
Contact: Interested patients may contact Brandon Johnson at 847-570-1643, bjohnson3@northshore.org

Laparoscopic Nissen Fundoplication (LNF) Surgery Versus Transoral Incisionless Fundoplication (TIF): Anti-Reflux Treatment Registry (STAR Registry)
Aims: Capture, review, and compare medical information, including symptoms, both types of TIF and LNF treatments, and complications that people with gastro-esophageal reflux (GERD) have and store this information for future research studies
Diagnosis: GERD
Principal Investigator: Michael Ujiki, MD
IRB Approval Number: EH14-303

The Establishment and Maintenance of a Data Registry for Bariatric Gastric Balloon Procedures
Aims: Capture, review, and compare medical information, including symptoms, treatments and complications that people with bariatric balloon surgery have and store this information for future research studies
Diagnosis: Obesity
Principal Investigator: Michael Ujiki, MD
IRB Approval Number: EH16-061

Closure vs Non-Closure of Primary Defect in Ventral Hernia Repair
Aims: To determine a difference in repairing ventral hernias by method of closing the primary muscle defect versus the method that does not close the primary muscle defect, both using mesh placement.
Diagnosis: Ventral hernia
Principal Investigator: Michael Ujiki, MD
IRB Approval Number: EH16-062
Contact: Interested patients may contact JoAnn Carbray at 847.570.3802, jcarbray@northshore.org

Prospective comparative study of urgent start peritoneal, traditional start peritoneal and hemodialysis in terms of outcomes, complications, and quality of life at NorthShore University HealthSystem

Aims: To measure quality of life differences between patients receiving urgent and traditional start peritoneal dialysis (PD) and hemodialysis (HD). To determine what factors govern the utilization of PD as an option in emergent and urgent dialysis patients and when and why patients switch modes of dialysis.
Diagnosis: End Stage Renal Failure (ESRF)
Principal Investigator: Stephen Haggerty, MD
IRB Approval Number: EH16-143
Contact: Interested patients may contact Peter Frost at 847.570.2935, pfrost@northshore.org

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 done at NorthShore or with collaborating institutions.
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: The objective of this project is to better characterize pre-operative measurement of sarcopenia to improve risk-stratification of older patients undergoing pancreatic cancer surgery.  The central hypothesis is that a combination of clinical, radiographic and molecular measures of sarcopenia can best predict important clinical outcomes.
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 Sean Aina, MBBS, CCRP 847.570.1572, saina@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 Jen Jaffe, MPH, CCRP 847.570.2803, jjaffe@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: Thomas Hensing, 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

A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thorascopic Lobectomies
Aims: This study is comparing rates of hemostatic interventions between the FDA approved ECHELON FLEX Powered Vascular Stapler with Advanced Placement Tip to the leading Standard of Care vascular stapler used in Video-Assisted Thorascopic Surgery (VATS) lobectomy.This study will be recruiting patients with suspected or confirmed stage IA to stage IIIA Non-Small Cell Lung Cancer who will be receiving a lobectomy.
Diagnosis: Non-small cell lung cancer (NSCLC) 
Principal Investigator: Seth Krantz, MD
IRB Approval Number: EH15-205
Sponsor: Ethicon Endo-Surgery
Contact: Interested patients may contact Patricia Park, CCRP at 847.570.1675, ppark@northshore.org
Open to Enrollment: Yes
ClinicalTrials.gov Identifier: NCT02702921

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. The genetic mutations which are being assessed are EGFR, ALK and PD-L1. Not all NSCLC tumors have a change in these genes. This study will lead into the optional treatment trials which will use specific drugs to target these genes as well as tumors without mutations. 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: Ki Wan Kim, 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: Ki Wan Kim, 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

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: Ki Wan Kim, 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

EA5142: 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 Cancers
Aims: The purpose of this study is to find if adding the study drug, nivolumab (also known as OPVIDO®), will limit lung cancer from growing back in patients with early stage non-small cell lung cancer. Patients will be given either nivolumab or placebo for up to one year after they have completed standard treatment for their lung cancer. 
Diagnosis: Non-Small Cell Lung Cancer patients with Stage IB-IIIA who have previously enrolled in the Alchemist Screening Trial A151216.
Principal Investigator: Ki-Wan Kim, MD
IRB Approval Number: EH16-268
Sponsor:  Alliance for Clinical Trials in Oncology
Contact:  Interested participants may contact the Surgical Research Office at 847.570.1512, cfredian@northshore.org
Open to Enrollment:  Currently open to enrollment for patients previously enrolled in the Alchemist screening trial A151216.

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 Peter Frost, BS at 847.570.2935, pfrost@northshore.org or Jen Jaffe, MPH, CCRP at 847.570.2803, jjaffe@northshore.org 
Open to Enrollment: Yes
ClinicalTrials.gov Identifier: NCT02457299

Best Practice in VATS Lobectomy and Segmentectomy for Lung Cancer: A Prospective, Observational, Quality Improvement Study to Optimize Care for Lung Cancer Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)
Aims: This is a multi-center study which will be conducted at seven sites. The purpose of this study is to establish a database for doing data and cost analysis of the workup, early treatment and follow-up of patients who have VATS lobectomy or segmentectomy for lung cancer.
Lung cancer is surgically treated by resection of the tumor. The procedure is called a VATS lobectomy or a segmentectomy. There are no established guidelines to describe best practice and procedure options for performing surgical resection of the tumor. The purpose of this study is to establish a database which will collect data on the workup, early treatment and follow-up of patients who have VATS lobectomy or segmentectomy for primary lung cancer. This data from 200 patients across all sites will be evaluated to propose the best practice protocol for this procedure and implemented on another cohort of 200 patients.
Diagnosis: Lung Cancer
Principal Investigator: Seth Krantz, MD
IRB Approval Number: EH13-155
Sponsor: Ethicon Endo Surgery
Contact: Interested participants may contact the Ujala Bokhary, MBBS, CCRP at 847.570.1783, ubokhary@northshore.org
Open to Enrollment: Yes