22 studies in Lung Cancer
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Genetic Epidemiology Of Lung Cancer
Rochester, MN
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Genetic Epidemiology Of Lung Cancer
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
The purpose of the study is to compare any inherited or genetic characteristics using blood or tissue specimens collected from individuals who have been diagnosed with lung cancer with the blood or tissue of their family members. The research study is funded by the National Cancer Institute and is part of a national research study being conducted by the Genetic Epidemiology of Lung Cancer Consortium (GELCC).
IRB Number:
07-007338Who can I contact for additional information about this study?
Mariza de Andrade, Ph.D. Principal Investigator Phone: (507) 284-1032 Email: mandrade@mayo.edu
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Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Lung Cancer That Was Removed By Surgery
Scottsdale and Phoenix, AZ
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Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Lung Cancer That Was Removed By Surgery
Location:
Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. Compare overall survival of patients with completely resected stage IB (tumors ≥ 4cm)-IIIA non-small cell lung cancer treated with adjuvant chemotherapy with or without bevacizumab. SECONDARY OBJECTIVES: I. Compare disease-free survival of patients treated with these regimens. II. Compare the toxicity of these regimens in these patients. III. Perform analyses of tissue and blood to establish factors that predict clinical outcome in patients treated with these regimens. IV. Determine whether smoking status is linked to outcome in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to type of chemotherapy (cisplatin/vinorelbine ditartrate vs cisplatin/docetaxel vs cisplatin/gemcitabine hydrochloride vs cisplatin/pemetrexed disodium), stage (IB vs II vs IIIA [N2] vs IIIA [T3, N1]), histology (squamous cell vs other), and gender. Patients are randomized to 1 of 2 treatment arms. ARM I (adjuvant chemotherapy without bevacizumab): Patients receive 1 of 4 chemotherapy regimens. REGIMEN 1: Patients receive vinorelbine ditartrate IV over 10 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following vinorelbine ditartrate administration. REGIMEN 2: Patients receive docetaxel IV over 1 hour on day 1 and cisplatin over 1 hour on day 1 immediately following docetaxel administration. REGIMEN 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following gemcitabine administration. REGIMEN 4 (non-squamous histology only): Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1 hour on day 1 immediately following pemetrexed disodium administration. In all regimens, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. ARM II (adjuvant chemotherapy with bevacizumab): Patients receive chemotherapy as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year. Patients complete smoking status questionnaires at baseline and then every 3 months during study treatment. After completion of study treatment, patients are followed periodically for 10 years.
NCT ID:
NCT00324805IRB Number:
07-005703Who can I contact for additional information about this study?
Rochester: Julian R. Molina 507-538-7623
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Scottsdale: Julian R. Molina 507-538-7623
Jacksonville: Julian R. Molina 507-538-7623
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Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer
Rochester, MN
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Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - Compare the disease-free survival of patients with small (≤ 2 cm) peripheral stage IA non-small cell lung cancer undergoing lobectomy vs sublobar resection (wedge resection or segmentectomy). Secondary - Compare the overall survival of patients undergoing lobectomy vs sublobar resection. - Compare the rates of loco-regional and systemic recurrence in patients undergoing lobectomy vs sublobar resection. - Compare the pulmonary function of these patients, as measured by expiratory flow rates at 6 months postoperatively. - Explore the relationship between characteristics of the primary lung cancer, as revealed by pre-operative CT scan and positron emission tomography (PET) imaging, and outcomes. - Determine the false-negative rate of preoperative PET scan for identification of involved hilar and mediastinal lymph nodes. - Assess the utility of annual follow-up CT scan after surgical resection in these patients. OUTLINE: This is a multicenter, randomized study. Patients are stratified according to tumor size (< 1 cm vs 1-1.5 cm vs > 1.5-2.0 cm) (based on the maximum dimension determined from the preoperative scan), histology (squamous cell carcinoma vs adenocarcinoma vs other), and smoking status (never smoked [smoked < 100 cigarettes over lifetime] vs former smoker [smoked > 100 cigarettes AND quit ≥ 1 year ago] vs current smoker [quit < 1 year ago or currently smokes]). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo lobectomy by open thoracotomy or video-assisted thoracoscopic surgery (VATS). - Arm II: Patients undergo a wedge resection or anatomical segmentectomy by open thoracotomy or VATS. After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 5 years.
NCT ID:
NCT00499330IRB Number:
07-005522Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer
Jacksonville, FL
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Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer
Location:
Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES:
- To determine the maximum tolerated dose of gold sodium thiomalate in patients with advanced non-small cell lung cancer.
- To describe the toxicities associated with this treatment.
- To describe any preliminary evidence of biologic activity.
- To further assess the correlation between PKCι expression and the antitumor effects of gold sodium thiomalate.
- To study the association of clinical (toxicity and/or tumor response or activity) with pharmacokinetic/pharmacodynamic parameters.
- To describe anti-proliferative activity of gold sodium thiomalate through 3-deoxy-3-[^18F]-fluorothymidine positron emission tomography imaging.
OUTLINE: This is a dose-escalation study of gold sodium thiomalate.
Patients receive gold sodium thiomalate intramuscularly on days 1, 8, 15 and 22. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive gold sodium thiomalate once every 4 weeks until a total cumulative dose of 1 gram is delivered.
Blood samples are collected at baseline and prior to therapy in weeks 3, 5, 7, 9, and 11. Samples are analyzed by mass spectometry for pharmacokinetics. Paraffin-embedded tumor tissue samples are analyzed for PKC_l expression and antitumor activity. Antiproliferative effects of gold sodium thiomalate are analyzed by 3-deoxy-3-[^18F]-fluorothymidine positron emission tomography imaging.NCT ID:
NCT00575393IRB Number:
06-003532Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
Jacksonville: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Three Different Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide
Scottsdale and Phoenix, AZ
Rochester, MN
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Three Different Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide
Location:
Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - To determine whether administering high-dose thoracic radiotherapy, 70 Gy (2 Gy once daily over 7 weeks) or 61.2 Gy (1.8 Gy once daily for 16 days followed by 1.8 Gy twice daily for 9 days), will improve median and 2-year survival compared with 45 Gy (1.5 Gy twice daily over 3 weeks) in patients with limited-stage small cell lung cancer. Secondary - To compare treatment-related toxic effects of thoracic radiotherapy regimens in patients with limited-stage small cell lung cancer. - To compare response rates, failure-free survival, and toxicity of thoracic radiotherapy regimens in patients with limited-stage small cell lung cancer. - To compare rates of local relapse, distant metastases, and brain metastases with these regimens. - To describe the patterns of use of thoracic intensity-modulated radiotherapy (IMRT) in patients with limited-stage small cell lung cancer. OUTLINE: This is a 2-part, multicenter, randomized study. Patients are stratified according to gender, weight loss 6 months prior to study entry (≤ 5% of body weight vs > 5% of body weight), ECOG performance status (0 vs 1 vs 2), radiotherapy technique (intensity-modulated radiotherapy vs 3-dimensional conformal radiotherapy), and radiotherapy start time (at first course of protocol chemotherapy, after one course of prior non-protocol chemotherapy vs at first course of protocol chemotherapy, without prior non-protocol chemotherapy vs at second course of protocol chemotherapy, without prior non-protocol chemotherapy). - Part 1: Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients undergo standard-dose (45 Gy given in 30 treatments) thoracic radiotherapy twice daily, 5 days a week, for 3 weeks. Patients also receive cisplatin IV on day 1 and etoposide IV on days 1, 2, and 3. - Arm II: Patients undergo higher-dose (70 Gy given in 35 treatments) thoracic radiotherapy once daily, 5 days a week, for 7 weeks. Patients also receive cisplatin and etoposide as in arm I. - Arm III: (discontinued as of 01/15/13) Patients undergo higher-dose (61.2 Gy given in 34 treatments) thoracic radiotherapy once daily, 5 days a week, during the initial 16 days (approximately 3 weeks) of treatment and then twice daily, 5 days a week, for the final 9 days (approximately 2 weeks) of treatment. Patients also receive cisplatin and etoposide as in arm I. In all arms, treatment with cisplatin and etoposide repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. - Part 2: An interim analysis, conducted after accrual of 30 patients per arm, will select one experimental arm based upon a comparison of treatment-related toxicity. The most toxic experimental arm will be discontinued, and the trial will continue comparing standard therapy (arm I) to the selected experimental regimen (arm II) as in part 1. Prophylactic radiotherapy: Within 3-6 weeks after completion of chemotherapy, patients with responding disease are eligible to undergo prophylactic radiotherapy to the brain once a day, 5 days a week, for 2 weeks. After completion of study treatment, patients are followed up at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years or until disease progression. At disease progression, patients are followed up every 6 months.
NCT ID:
NCT00632853IRB Number:
08-004290Who can I contact for additional information about this study?
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Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
Rochester, MN
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Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
Location:
Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - To determine the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT) in medically inoperable patients with centrally located stage I non-small cell lung cancer. (Phase I) - To determine the efficacy of SBRT when administered at the MTD in these patients. (Phase I) - To estimate the local control rate of SBRT at the MTD in these patients. (Phase II) Secondary - To estimate the rates of adverse events (other than dose-limiting toxicity) of ≥ grade 3 that is possibly, probably, or definitely related to treatment and that occurs within 1 year after the start of SBRT in these patients. - To estimate the rates of late adverse events (i.e., occurs > 1 year after the start of SBRT) in these patients. - To estimate the local control and progression-free and overall survival rates in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo stereotactic body radiotherapy every 2 days over 1½-2 weeks (total of 5 fractions) in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically.
NCT ID:
NCT00750269IRB Number:
09-001765Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Inositol in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia
Scottsdale and Phoenix, AZ
Rochester, MN
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Inositol in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia
Location:
Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. To evaluate the efficacy of myo-inositol (inositol) 9 grams by mouth twice a day for 6 months versus placebo to revert bronchial dysplasia in current/former smokers with or without curatively treated Stage 0/I non-small cell lung cancer. SECONDARY OBJECTIVES: I. To further define the mechanism(s) of action of pharmacological doses of myo-inositol as a lung cancer chemopreventive agent by evaluating changes in: the number of dysplastic lesions, Ki-67, caspase-3, peroxisome proliferator-activated receptor (PPAR) gamma, cyclin D1, cyclin E and vascular endothelial growth factor (VEGF) immunostaining in bronchial biopsies; gene expression analysis of ribonucleic acid (RNA) from bronchial brush cells; and changes in inflammatory biomarkers (C-reactive protein [CRP], monocyte chemotactic protein-1 [MCP-1], myeloid progenitor inhibitory factor-1 [MPIF-1] and L-Selectin) levels in bronchoalveolar lavage (BAL) and plasma before and after treatment. II. To collect additional safety and adverse event profiles of participants enrolled in both intervention arms. III. To establish a biospecimen repository archive for future correlative studies. OUTLINE: Patients are stratified according to smoking status (current vs former), prior lung cancer (yes vs no), and number of dysplastic lesions at baseline (1 vs > 1). Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. ARM II: Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. Patients undergo white light and autofluorescence bronchoscopy with bronchoalveolar lavage, bronchial brushings, and biopsies as well as optical coherence tomography imaging and blood sample collection at baseline and after completion of study treatment. Samples are analyzed for tissue biomarkers (e.g., PPAR gamma, Ki-67, caspase-3, cyclin D1, cyclin E, and VEGF) by immunohistochemistry (IHC); cytokine levels (e.g., CRP, MCP-1, MPIF-1, and L-selectin) by ELISA; and gene expression profiles of RNA by microarray. After completion of study treatment, patients are followed within 30 days.
NCT ID:
NCT00783705IRB Number:
07-002976Who can I contact for additional information about this study?
Rochester: Paul J. Limburg 507-284-2511
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Scottsdale: Paul J. Limburg 507-384-2511
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Validation of a Multi-gene Test for Lung Cancer Risk
Rochester, MN
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Validation of a Multi-gene Test for Lung Cancer Risk
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
Because more than 160,000 individuals die of lung cancer/year in the United States alone, it is important to use the best possible methods to determine whether increased surveillance of individuals at highest risk for lung cancer will result in reduced lung cancer mortality. The Lung Cancer Risk Test (LCRT) proposed for evaluation promises to accurately identify the 10-15% of the population that is most susceptible to lung cancer based on genetic predisposition. More than 90 million individuals in the United States alone are demographically at high risk for lung cancer and potential candidates for increased surveillance.
NCT ID:
NCT01130285Who can I contact for additional information about this study?
Rochester: Cindy Beinhorn 507-538-0595
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Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer
Scottsdale and Phoenix, AZ
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Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer
Location:
Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - To ascertain whether patients treated by stereotactic body radiation therapy (SBRT) have a 3-year overall survival (OS) rate that is no more than 10% less than patients treated with sublobar resection (SR). Secondary - To compare loco-regional recurrence-free survival between study arms. - To compare disease-free survival between study arms. - To compare grade 3 or higher specific adverse event profiles between study arms at 1, 3, 6, and 12 months post-therapy. - To compare pulmonary function between patients treated with SBRT and patients treated with SR. - To compare the adverse events and pulmonary function tests (PFTs) in each arm for patients with low or high Charlson comorbidity index scores, including a test interaction between Charlson comorbidity index scores (low vs high) and treatment arm. Tertiary - To compare the quality-adjusted survival between the SBRT and SR treatments in terms of time to death (primary) and time until recurrence (secondary). - To examine whether pre-operative and post-operative clinically significant deficits in previously identified prognostic PRO domains (overall quality of life [QOL], fatigue, anxiety, and dyspnea) are associated with shorter patient survival in this patient population and to compare the relative effectiveness of each treatment (SBRT and SR). - To contribute to an ACOSOG bank of normative data in order to improve short/long-term outcomes of cancer patients by identifying patients experiencing clinically significant deficits in patient-reported outcomes and the relationship to genetic variables. - To explore whether blood-based biomarkers, including osteopontins, will be able to predict which patients will be at high risk for recurrence by treatment with either SBRT or SR. (exploratory) - To explore whether blood-based biomarkers, including TGF-β1, will be able to predict which patients will be at high risk for pulmonary complications by treatment with either SBRT or SR. (exploratory) OUTLINE: This is a multicenter study. Patients are stratified according to planned brachytherapy (yes vs no) and ECOG performance status (0 vs 1 vs 2). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo sublobar resection comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy* comprising an iodine I 125 implant at the resection margin. - Arm II: Patients undergo 3 fractions of stereotactic body radiation therapy at 2-8 days apart. NOTE: *Patients may receive brachytherapy at the discretion of treating physician. Patients may undergo blood sample collection at baseline and periodically during study for correlative studies. Tumor tissue samples may also be collected from patients who undergo resection. Patients complete the Lung Cancer Symptom Scale (LCSS), the Linear Analogue Self-Assessment (LASA), and the UCDS Shortness of Breath quality-of-life questionnaires at baseline and periodically during study and follow-up. After completion of study treatment, patients are followed up for 30 days, every 3 months for 2 years, every 6 months for 1 year, and then yearly for 2 years.
NCT ID:
NCT01336894IRB Number:
11-003256Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma
Rochester, MN
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Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: Maximum tolerated dose (MTD) for the intrapleural administration of a modified vaccine strain measles virus (MV) genetically engineered to produce human thyroidal sodium iodine symporter (NIS) (MV-NIS [oncolytic measles virus encoding thyroidal sodium iodide symporter])in patients with MPM. SECONDARY OBJECTIVES: Safety and toxicity of the repeated (up to 6 cycles) intrapleural administration of MV-NIS in patients with malignant pleural mesothelioma. TERTIARY OBJECTIVES: I. Time course of viral infection, dissemination and elimination by non-invasive measurements of NIS gene expression using radioactive iodine and single-photon emission computed tomography (SPECT)/ computed tomography (CT) imaging with. II. Viremia, viral replication, and viral shedding following intrapleural administration. III. Changes in humoral and cellular anti-MV immunity following the intrapleural administration of MV-NIS. IV. Antitumor efficacy of this approach by serial measurements of radioiodine uptake by SPECT/CT, radiographic response, and time to disease progression. V. Changes in both local and systemic innate and adaptive anti-tumor immunity following the intrapleural administration of MV-NIS. VI. Effect of MV-NIS administration on the eukaryotic initiation factor (eIF) 4F translation complex in mesothelioma cells. OUTLINE: This is a dose-escalation study. Patients receive the oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) intrapleurally. In the absence of unacceptable side effects or disease progression treatment can be repeated every 28 days for up to 6 courses. After completion of study treatment, patients are followed up every 3 to 6 months for up to 5 years.
NCT ID:
NCT01503177IRB Number:
10-002604Who can I contact for additional information about this study?
Rochester: Mayo Clinic Clinical Trials Referral Office 507-538-7623
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