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  • Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) (ALCHEMIST) Rochester, Minn.

    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.

  • Center for Regenerative Medicine Biotrust Biomaterial Repository Rochester, Minn.

    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.

  • Chemotherapy Followed by Surgery and Neoadjuvant Hemothoracic Intensity Modified Radiation Therapy (IMRT) for Patients with Malignant Pleural Mesothelioma Rochester, Minn.

    The purpose of this study is to follow patients with malignant mesothelioma of the lung after they have had combined chemotherapy, surgery, and intensity modified radiation therapy and determine response rates and overall survival.

  • DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study) (DELFI-L101) Rochester, Minn.

    The purpose of this study is train and test classifiers for lung cancer detection using the DELFI assay and other biomarker and clinical features. 

  • Long Term Evaluation of Thymoma Recurrence Rochester, Minn.

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

  • Neonatally-derived Tissues for Regenerative Biotherapeutic Development Rochester, Minn.

    This purpose of this study is to centralize the collections of human blood products and tissue samples for the purpose of establishing a resource for those investigating regenerative medicine as a therapy. Its overall goal is to produce a Good Manufacturing Practice compliant, allogeneic therapeutic cell bank whereby therapeutic progenitor cells are obtained from perinatal tissue and/or their acellular derivatives and umbilical cord blood collected from consented donors who meet 21 CFR 1271 donor eligibility criteria. Ultimately, to develop procedures detailing the isolation and expansion of progenitor cells and products derived from these cells such as extracellular vesicles for development of pre-clinical analysis to gather the data for future Investigational New Drug (IND) submissions to the FDA.

  • 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.

  • Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement Rochester, Minn. Cellspan™ Esophageal Implant-Adult (CEI) The CEI is a combination product consisting of an engineered synthetic scaffold (device constituent) seeded and cultured with the patient's adipose derived mesenchymal stem cells (biologic constituent), intended to stimulate regeneration of a structurally intact, living biologic esophageal conduit, in patients requiring full circumferential esophageal reconstruction up to 6 cm segment in length. This is a single arm, unblinded, multicenter, prospective first-in-human (FIH) feasibility study to be performed at a maximum of 5 centers in the United States with a maximum of 10 subjects in total. All subjects will be followed for a minimum of 2 years post-implant surgery. Since this is an FIH experience, the study will utilize an independent Data Monitoring Committee (DMC) to evaluate safety on a continuous basis to mitigate any safety risks to subjects. A sentinel approach to enrollment of subjects shall be guided by the DMC review of cases.
  • Stem Cell Based Therapeutics for Chronic Disease Rochester, Minn.

    The purpose of this study is to produce, using current Good Manufacturing Practices (cGMPs), a bank of 50 primary fibroblast cell lines from skin biopsies obtained by consenting donors who meet 21 CFR 1271 donor eligibility criteria, and to use fibroblasts in the cell bank generated in aim 1 to produce new induced pluripotent stem cell lines using Good Manufacturing Practices (cGMPs). These iPSC lines will then be screened to identify those with optimal characteristics for treatment purposes, as well as for the potential generation of transplantable tissues and therapeutics for chronic disease.

  • Surgery for Mesothelioma After Radiation Therapy “SMART” for Resectable Malignant Pleural Mesothelioma (SMART) Rochester, Minn.

    The purpose of this study is to assess the possibility, safety, and therapeutic effect of administering a short, quick course of high-dose radiation treatment focused on half of the chest, followed by surgery to remove that portion of the lungs, in patients with malignant pleural mesothelioma.  

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  • A Clinical Pathway for the Treatment of Multifocal Lung Adenocarcinoma Using Genome Sequencing Rochester, Minn.

    To gather preliminary safety and outcome data for the multimodality treatment of lung adenocarcinoma in the setting of multifocal BAC.

  • A Phase I Study of iPS Cell Generation From Patients With COPD Rochester, Minn.

    As part of the long-term goal of successfully implementing tissue regeneration strategies in an individualized manner for patients with thoracic diseases including, but not limited to: cystic fibrosis, pulmonary fibrosis and pulmonary hypertension, the investigators will assess the feasibility of collecting skin biopsies from patients undergoing surgery for thoracic disease, culturing skin fibroblasts from the biopsy, and reprogramming these skin fibroblasts into induced pluripotent cells.

  • A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 CM) Peripheral Non-Small Cell Lung Cancer Rochester, Minn.

    RATIONALE: Wedge resection or segmentectomy may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer.

    PURPOSE: This randomized phase III trial is studying different types of surgery to compare how well they work in treating patients with stage IA non-small cell lung cancer.

  • A Pilot Study of Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer Rochester, Minn.

    The purpose of this study is to learn whether it is better to receive the drug Metformin with standard of care for lung cancer or just standard of care.

  • A Pilot Study to Isolate and Test Circulating Tumor Cells Using the ClearCell® FX EP+ System Rochester, Minn.

    The purpose of this study is to isolate and measure circulating tumor cells in the blood stream to advance detection of cancer and treatment monitoring. In this study, the investigators will utilize the novel technology for circulating tumor cell detection in order to evaluate their presence in patients with lung cancer.

  • Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) (ALCHEMIST) 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.

  • Center for Regenerative Medicine Biotrust Biomaterial Repository Jacksonville, Fla., 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.

  • Exceptional Responders Pilot Study: Molecular Profiling of Tumors From Cancer Patients Who Are Exceptional Responders Rochester, Minn., Scottsdale/Phoenix, Ariz.

    Background:

    - Cancer can happen when a person s genes change in a way that makes cells grow uncontrolled. Researchers want to see what changes in genes might make some people with cancer respond well to some treatments. This may lead to better ways to prevent, detect, and treat cancer and other diseases.

    Objectives:

    - To see what changes in genes might make some people with cancer respond well to some treatments.

    Eligibility:

    - People who are documented exceptional responders to cancer treatment. They must have given a tumor sample that is available to researchers.

    Design:

    • Participants will be screened with reports of their radiology scans or other evidence that shows exceptional response.
    • Participants will provide permission for researchers:
    • To test cancer tissue that has previously been removed.
    • To test normal tissue (blood) that has previously been collected, if available.
    • To obtain data from their medical records.
    • Data will be kept in an anonymous database. Other researchers may share the data.
    • No new tissue will be collected from participants.
  • Identification of Prognostic Biomarkers for Progression of Invasive Squamous Cell Carcinoma Rochester, Minn.

    The study will utilize both retrospective and prospective data collection from patients that already had a bronchoscopy and lung resection or will have a bronchoscopy and lung resection for squamous cell carcinoma. The investigators plan to prospectively collect 5 bronchoscopic biopsies, 3ml blood and one tumor and adjacent normal samples from 200 qualified patients who meet the study criteria.

  • Isolation, Activation and Expansion of Mutation Reactive T-cells Rochester, Minn.

    The purpose of this study is to examine the ease and practicality of extracting central memory T-cells and the potential for their activation and ability to recognize tumor antigens and target lung cancer cells for destruction.  Circulating cell-free DNA (cfDNA) from the plasma will be extracted and sequenced to identify somatic mutations that were exposed to the T-cells.

  • Progenitor Cells in Human Esophagus Rochester, Minn.

    The purpose of this study is to better understand how esophageal cells change with age.

  • Randomized Phase II Trial of Stereotactic Body Radiotherapy (SBRT) versus Sublobar Resection for High-Risk Patients with Early Stage Non-Small Cell Lung Cancer (NSCLC) ≤ 5cm Rochester, Minn.

    This randomized phase II trial is for medically inoperable early stage non-small cell lung cancer (NSCLC) patients. It is designed to compare the number of patients who are disease free and alive at 2 years between Stereotactic Body Radiotherapy (SBRT) and surgical intervention arms. SBRT is less invasive and felt to be equally effective to surgery for early stage NSCLC. Surgery is currently the standard of care for these patients. The hypothesis of this study is that SBRT is at least as good as surgery for disease free survival at 2 years.

  • Registry Trial of Active Surveillance for Multifocal Ground Glass Opacities (GGOs) Rochester, Minn.

    The purpose of this study is to establish a registry for the active surveillance of patients with multiple ground glass opacities (GGOs) in the lung identified on imaging.

     

     

  • Staging Procedures to Diagnose Malignant Pleural Mesothelioma Rochester, Minn.

    The purpose of this study is to compare whether surgical staging is more accurate than imaging procedures when diagnosing malignant lung mesothelioma.

  • Use of Intra-Operative Shear Wave Ultrasound Vibrometry for Characterization of Esophageal Malignant Tumors Rochester, Minn.

    Using the analysis of group velocity for a screening application and then higher order analysis based on the elastic and viscious components of the shear modulus may allow discrimination between extent of tumor invasion through the esophageal wall if appropriately correlated with pathological findings.

  • Yield and Quality of Genetic Analytes (DNA and RNA) Extracted from Esophageal Tissues after Esophagectomy Rochester, Minn.

    The purpose of this study is to learn about why esophageal cancer develops. We would like to test the tissue to find out which way of saving esophageal tissue gives us the best information (DNA and RNA) to use for future studies and collect a blood sample to use as a comparison for normal and tumor DNA.

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