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Dielectric Properties of Matched Tissue Samples From Thoracic Malignancies and Corresponding Normal Tissues

March 19, 2021
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The purpose of the Dielectrics Properties of Thoracic Malignancies Study (DPTMS) is to provide a wealth of knowledge for investigators involved in establishing a new and effective treatment for a variety of solid tumors using tumor treatment fields. It is intended to provide biospecimen (tumor/healthy) together with demographic data (age, sex, race, occupational history, and other epidemiologic information), and clinical data (stage, treatment, survival information, and annotated CT’s). Our specific aims are to test the following hypotheses: 1) Electric properties of thoracic tumors differ from electric properties of surrounding healthy tissue 2) Different tumor types will have different electric properties 3) Electric properties of individual tumors are heterogeneous 4) Electric properties of tumors are related to the structure and composition of the underlying tissue 5) Use of standard medical imaging data (CT) will permit mapping of electric properties.

Frequency and Clinical Phenotype of BAP1 Hereditary Predisposition Syndrome

March 12, 2021
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Primary Outcome Measures Prevalence of germline BAP1 variants in the unselected general population of cancer patients [ Time Frame: 5 years ] Clinical phenotypes (this includes premalignant lesions, tumor type and age of onset) in at risk blood-line family members of the patients [ Time Frame: 5 years ] Secondary Outcome Measures Environmental risk factors modifying cancer risk [ Time Frame: 10 years ] Genetic risk factors…

Evaluation of the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy (MESOIMMUNE)

March 5, 2021
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Primary Outcome Measures Disease control [ Time Frame: 12 weeks ] Disease control rate at 12 weeks Secondary Outcome Measures Survival with anti-PD1/PDL1 immunotherapy [ Time Frame: 12 weeks ] Overall survival from treatment with anti-PD1/PDL1 immunotherapy Duration of treatment [ Time Frame: 12 weeks ] Duration of treatment with PD1/PDL1 immunotherapy Survival [ Time Frame: 12 weeks ] Overall survival from the start of the first treatment Tolerance of treatment…

Neoadjuvant Toripalimab Combined With Chemotherapy in the Treatment of Malignant Pleural Mesothelioma

January 22, 2021
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This is a single-arm, open, II phase study to evaluate the safety and efficacy of Toripalimab, pemetrexed and carboplatin in the treatment of locally advanced malignant MPM in 15 newly diagnosed patients with locally advanced malignant MPM.

A Two-part Study to Characterize Drug-Drug Interaction Effects on Steady-State Pharmacokinetics of Oral Tazemetostat

September 4, 2020
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This is a phase I, multi-center, open-label, multi-dose, two-part PK and safety study to characterize the DDI potential of oral Tazemetostat.

Intravenous Magnesium in Patients Receiving Cisplatin

August 7, 2020
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Primary Outcome Measures Feasibility and acceptability as measured by participant rates of enrollment [ Time Frame: 6 months ] Feasibility assessed by % of patients that agree to participate. Project feasible if >30% of the patients approached agree to participate Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 [ Time Frame: Time of magnesium infusion till 2…

Efficacy of a Maintenance Treatment With TALAzoparib Following First Line Platinum-based Chemotherapy in Malignant MESOthelioma (TALAMESO)

July 24, 2020
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Primary Outcome Measures Non-progression proportion [ Time Frame: 6 month after starting talazoparib ] The non-progression proportion is defined as the proportion of patients free of progression 6 months after talazoparib start. Disease progression will be based on (i) tumor assessment made by the investigators according to the RECIST 1.1 criteria and/or, ii) non-equivocal clinical symptom of disease progression…

High Resolution Computed Tomographic Imaging, Noninvasive (Liquid) Biopsies, and Minimally Invasive Surgical Surveillance for Early Detection of Mesotheliomas in Patients With BAP1 Tumor Predisposition Syndrome

July 17, 2020
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Primary Outcome Measures Prospectively gather information related to the use of high-resolution computed tomographic imaging (HRCT) including photon counting CT (PCCT) scans, together with minimally invasive surveillance for early detection of mesotheliomas in pts with … [ Time Frame: annual or bi-annual followup, 5 years interim analysis ] Documentation of the counts, incidence, and frequencies…

Cryoablation for the Promotion of Local Tumor Infiltration in Patients With Mesothelioma

June 26, 2020
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Primary Outcome Measures Local tumor infiltration by cytotoxic cluster of differentiation 8 positive (CD8+) cells [ Time Frame: After cryoablation of mesothelioma up to 1 year ] Will be tested by cryoablating a small region of tumor at the time of pleural biopsy. Preponderance of T cells in ablated tumor tissue in comparison to non-cryoablated tissue [ Time Frame: Up to 1…

Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma (MESO-PRIME)

November 22, 2019
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This is a multi-centre non-randomised open-label phase 1 trial of pembrolizumab given in combination with SBRT to part of a pleural-based lesion in patients with unresectable MPM. This study will recruit up to 18 patients whose MPM has progressed beyond first-line of palliative chemotherapy, with a platinum-based doublet, and now requires further palliative systemic treatment, or have declined first-line palliative chemotherapy, however must have been considered suitable for a platinum doublet chemotherapy.