Diagnosis: Breast Cancer
Study Name and Description:
Prospective Observational Trial of Breast MRI in Newly Diagnosed Breast Cancers
The purpose of this study is:
- to determine whether there is a group of specific breast cancer patients who will benefit from breast MRI imaging before surgery
- to see if the MRI will reveal more information than the mammogram or ultrasound about the size and extent of tumor in order to plan the best surgical approach (and avoid additional surgical procedures)
- to measure the quality of life in women with breast cancer before their MRI and after surgery
Study participation is 10 years. Patients will undergo breast MRI prior to surgery and complete quality of life questionnaires prior to their MRI, at their first post-op visit with their surgeon and at 3-, 6-, and 12-months after surgery. Follow-up information will be collected from the medical record for the remaining 9 years of the study.
Principal Investigator: Katharine Yao, MD
Sponsor: NorthShore University HealthSystem
Contact: For more information, interested participants may contact the Research Coordinator at 847.570.1681 or email bmartz@northshore.org
Diagnosis: Breast Cancer
Study Name and Description:
Z1041 A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed By Paclitaxel Plus Trastuzumab With a Neoadjuvant Regimen of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients with Palpable and Operable Breast Cancer”
This NCI study will enroll women who have palpable operable breast cancer tumors with an overactive gene called HER2, or the Human Epidermal Growth Factor Receptor 2. The purpose of the study is to see how the tumor responds to treatment with trastuzumab (Herceptin) given along with chemotherapy drugs before surgery.
Study therapy will last about 12-15 months and participation in this study will last for 5 years to keep track of the patient’s overall health.
Principal Investigator: David J. Winchester, MD
Sponsor: American College of Surgeons Oncology Group
Contact: For more information, interested participants and clinicians may contact the Surgical Research Office at 847.570.1632 or email joleary@northshore.org
Diagnosis: Breast Cancer
Study Name and Description:
Z1031 A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 MG Daily), Letrozole (2.5MG), or Anastrozole (1MG) In Postmenopausal Women with Clinical Stage II and III Estrogen Receptor Positive Breast Cancer.
This NCI study will enroll postmenopausal women with a palpable operable estrogen receptor positive breast cancer. The purpose of this randomized study is to see how the tumor responds to treatment with an aromatase inhibitor medication given before surgery.
Study therapy will last 16-18 weeks before surgery and participation in this study will last for 10 years to keep track of the patient’s overall health.
Principal Investigator: David J. Winchester, MD
Sponsor: American College of Surgeons Oncology Group
Contact: For more information, interested participants and clinicians may contact the Surgical Research Office at 847.570.1632 or email joleary@northshore.org
Diagnosis: Breast Cancer, or High Risk of Breast Cancer
Study Name and Description:
The Prospective Study of Nipple-Sparing Mastectomy: Oncologic and Reconstructive Outcomes
This study will examine the treatment and aesthetic outcomes for women undergoing nipple sparing mastectomy and immediate breast reconstruction for risk reduction or breast cancer treatment. The overall goal of this study is to demonstrate a safe, reliable procedure with improved aesthetic outcome, thereby decreasing the surgical stigmata following mastectomy.
Patients will be seen at least once a year for 5 years to obtain follow up information and complete quality of life questionniares.
Principal Investigator: Michael A. Howard, MD
Sponsor: NorthShore University HealthSystem
Contact: For more information, interested participants and clinicians may contact the Surgical Research Office at 847.570.1681 or email bmartz@northshore.org.
Diagnosis: Patients who undergo open small or large bowel surgery
Study Name and Description:
A Phase II, Double Blind, Placebo-Controlled, Dose Finding Study to Evaluate the Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function in Patients Following Large or Small Bowel Resection with Primary Anastomosis.
The purpose of this study is to investigate the safety and effectiveness of the study drug ipamorelin in preventing post operative ileus (bowel obstruction). The study is designed to find the most effective dose of ipamorelin, and if it is safe and well tolerated.
Study duration: The drug or placebo will be administered three times a day after surgery for the total of 7 days while in the hospital.
Follow-up: 14 days after discharge from the hospital
Principal Investigator: Marc Singer, MD
Sponsor: NorthShore University HealthSystem
Contact: For more information, interested participants may contact the Surgical Research Office at 847.570.1632 or email joleary@northshore.org
Diagnosis: Pancreatic Cancer
Study Name and Description:
Z5041: A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients with Operable Pancreatic Adenocarcinoma
The purpose of this study is to find out whether a combination of chemotherapy drugs given before surgery can help to increase the likelihood of complete surgical removal of the tumor.
Gemcitabine will be given by injection into a vein every week for 3 weeks, followed by a one week break and then once a week for 3 more weeks. During this time the patient will take an erlotinib pill every day for 43 days. Surgery to remove the pancreas will be performed 3-6 weeks later. The same schedule of gemcitabine and erlotinib will be given 5-10 weeks after surgery.
Study duration is about 5 years. After completing the chemotherapy after surgery, patients are instructed to see their doctor every 3 months for 2 years, then every 6 months for 2 years.
Principal Investigator: Mark Talamonti, MD
Sponsor: NorthShore University HealthSystem
Contact: For more information, interested participants may contact the Surgical Research Office at 847.570.1632 or email joleary@northshore.org
Diagnosis: Permanent Atrial Fibrillation
Study Name and Description:
EPICOR High Intensity Focused Ultrasound Application in the Surgical Treatment of Atrial Fibrillation
The purpose of this research study is to test the safety and effectiveness of the Epicor Cardiac Ablation System to treat permanent atrial fibrillation (present for at least 6 months) in patients who are having mitral valve surgery.
Study duration lasts six months.
Principal Investigator:: John C. Alexander, MD
Sponsor: St. Jude Medical
Contact: For more information, interested participants and clinicians may contact the Surgical Research Office at 847.570.1632 or email joleary@northshore.org