Thoracic Surgery

Below are current clinical trials.

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1. Mayo Clinic Upper Digestive Disease Survey

   Rochester, Minn.

   The Mayo Clinic Upper Digestive Disease Survey has been created in order to have a consistent evaluation tools for patients undergoing esophageal reconstruction or treatment  or patients that are experiencing an upper digestive disease in order to standardize and validate outcome measures.  Data will be used to establish the validation of the questionnaires/survey.  Data will also lead to the establishment of “normal” or expected scores for patients undergoing each type of esophagectomy procedure and for upper digestive diseases.  Data will contribute to creating treatment algorithms for symptom management for upper digestive diseases and for post-operative complications and symptoms as well as contribute to pre-operative education.  

2. Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now

   Rochester, Minn.

   REVOLUTION will be a US multicenter observational registry in scope and governed by a steering committee of approximately 8 experts in NSCLC and outcomes research. The primary goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to those with EGFR mutations may be enrolled following the initial study period as needed to ensure adequate sample sizes needed to examine primary questions of interest in the EGFR mutant population. Patients will be enrolled over a three year period across approximately 25 geographically diverse academic as well as community based sites within the US. The five year follow-up period will ensure robust survival data for correlations with clinical, tumor, and treatment variables.

   The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with particular characteristics of interest including patients with adenocarcinoma, and EGFR mutations and effectively evaluate these patients with respect to key outcomes of interest including overall survival, time to progression, stage at progression, secondary metastases including brain metastases (at diagnosis and progression), comorbidity burden, and performance status at index date.

   The study design allows a cross-sectional perspective with collection of detailed patient and clinical characteristics at enrollment followed by longitudinal assessment of clinician and patient-reported endpoints every three months. Centralized follow-up will be conducted by having sites upload patient data following each visit via the web-based data system, with patients who do not show up for site visits being contacted via telephone by the Duke Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will be weighted based upon provider specialty and ability to enroll patients with NSCLC with the specified inclusion criteria.

3. A Study to Collect Thoracic Specimens to Develop a Thoracic Specimen Registry

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The primary objective of this proposal is to develop a Thoracic Specimen Registry at Mayo Clinic. The purpose of the registry will be to support ongoing research in the etiology, early diagnosis, clinical management, and prognosis of lung cancer and other cancers and diseases of the thorax by developing a complete repository of specimens from patients with thoracic disease including but not limited to suspected lung cancer, mediastinal and pleural tumors and from patients at a very high risk of developing other thoracic cancers or other thoracic diseases. 

4. Genetic Testing in Screening Patients with Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

5. A Study of the Making and Storage of a Bank of Special Stem Cells for Use in Future Research and the Growth of New Cells

   Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The purpose of this study is the growing and storage of stem cells, made using the tissue samples of patients and others. As new technologies develop, these cells may be able to be grown into new cells to replace those damaged by disease or injury.

6. A Study to Evaluate Thymoma Recurrence

   Rochester, Minn.

   The purpose of this study is to evaluate thymoma recurrence rates in patients who underwent thymectomy.

7. A Study to Collect Medical and Personal Histories, Blood and/or Tumor Tissue Samples from Patients Who are Long-term Survivors of Lung Cancer

   Rochester, Minn.

   The purpose of this study is to collect medical and personal histories, blood and/or tumor tissue samples from patients who are long-term survivors of lung cancer. This study will help us to develop better ways to provide care and advice, develop better treatments to minimize long-term side effects, and improve the quality of life and outcome of lung cancer patients. This study will also help us to learn whether certain genes (inherited factors from your parents) increase the risk of developing or dying of lung cancer.

8. A Study to Establish a Pediatric Spine Registry

   Rochester, Minn., Minneapolis, Minn.

   The purpose of this study is to collect data about patients with chest wall and spinal deformities to develop a multicenter registry.  This will speed the pace of medical advancement and treatment recommendations for these conditions. 

9. A Study to Evaluate Progenitor Cells for Patients with Degenerative Lung Disease

   Rochester, Minn.

   The purpose of this study is to use a patient's own cells to fabricate a recellularized scaffold to repopulate the lung and restore function that could offer a solution for patients with degenerative lung disease.

10. ALEX Study: A Randomized, Phase III Study Comparing Alectinib with Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Patients

    Scottsdale/Phoenix, Ariz.

    This randomized, active controlled, multicenter Phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with critozinib treatment in patients with treatment-naive ALK-positive advanced NSCLC. Patients will be randomized in a 1:1 ratio to receive either alectinib, 600 mg orally twice daily (BID), or critozinib, 250 mg orally BID. Patients will receive treatment until disease progression, unacceptable toxicity, consent withdrawal or death occurs. The study is expected to last approximately 42 months.