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dbGaP phs000299 Genentech Lung Cancer Sequencing - pht001553.v2.p1

- 10/12/22 - 6 forms, 1 itemgroup, 5 items, 1 language
Itemgroup: pht001553
Principal Investigator: Zemin Zhang, PhD, Genentech Inc., South San Francisco, CA, USA MeSH: Lung Neoplasms,Carcinoma, Non-Small-Cell Lung https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000299 Version 1 Whole genome sequencing was applied to tumor and adjacent normal lung tissue in an individual non-small-cell lung cancer patient. We present an analysis of somatic changes identified throughout the tumor genome, including single-nucleotide variants, copy number variants, and large-scale chromosomal rearrangements. Over 50,000 high-confidence single-nucleotide variants were identified, revealing evidence of substantial smoking-related DNA damage as well as distinct mutational pressures within the tumor resulting in uneven distribution of somatic mutations across the genome. Version 2 Lung cancer is a highly heterogeneous disease in terms of both underlying genetic lesions and response to therapeutic treatments. We performed deep whole genome sequencing and transcriptome sequencing on 19 lung cancer cell lines and 3 lung tumor/normal pairs. Overall, our data show that cell line models exhibit similar mutation spectra to human tumor samples. Smoker and never-smoker cancer samples exhibit distinguishable patterns of mutations. A number of epigenetic regulators are frequently altered by mutations or copy number changes. A systematic survey of splice-site mutations identified over 100 splice site mutations associated with cancer specific aberrant splicing, including mutations in several known cancer-related genes. Differential usages of splice isoforms were also studied. Taken together, these data present a comprehensive genomic landscape of a large number of lung cancer samples and further demonstrate that cancer specific alternative splicing is a widespread phenomenon that has potential utility as therapeutic biomarkers.

pht001881.v2.p1

1 itemgroup 2 items

pht001882.v2.p1

1 itemgroup 7 items

pht001551.v2.p1

1 itemgroup 5 items

pht001552.v2.p1

1 itemgroup 5 items

Eligibility

1 itemgroup 4 items

Eligibility NCT00858364 Non-Small Cell Lung Cancer - Eligibility

- 9/20/21 - 1 form, 2 itemgroups, 33 items, 2 languages
Itemgroups: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00858364

Eligibility Lung Cancer NCT00955175

- 9/20/21 - 1 form, 1 itemgroup, 11 items, 1 language
Itemgroup: Criteria
Hypofractionated 3-Dimensional Radiation Therapy in Treating Patients With Newly Diagnosed Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer. ICORG 99-09; ODM derived from: https://clinicaltrials.gov/show/NCT00955175

Eligibility NCT00242801 NSCLC - Eligibility

- 12/11/13 - 1 form, 2 itemgroups, 6 items, 2 languages
Itemgroups: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00242801

Eligibility Lung Cancer NCT00653250

- 1/19/16 - 1 form, 1 itemgroup, 16 items, 1 language
Itemgroup: Criteria
Celecoxib in Treating Patients With Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00653250

Eligibility NCT00997230 Newly Diagnosed Locally Advanced or Metastatic NSCLC - Eligibility

- 12/7/13 - 1 form, 1 itemgroup, 2 items, 2 languages
Itemgroup: Inclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00997230

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Eligibility Criteria

- 4/20/21 - 1 form, 5 itemgroups, 27 items, 1 language
Itemgroups: Administrative, Inclusion Criteria, Exclusion Criteria, Inclusion/ Exclusion, Investigator's Signature
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Module 2 - Laboratory Tests - Haematology; Blood Chemistry; Urinalysis

- 4/28/21 - 1 form, 4 itemgroups, 21 items, 1 language
Itemgroups: Administrative, Laboratory Tests - Haematology, Laboratory Tests - Blood Chemistry, Laboratory Tests - Urinalysis
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Laboratory Tests - Haematology; Blood Chemistry; Urinalysis

- 4/21/21 - 1 form, 4 itemgroups, 28 items, 1 language
Itemgroups: Administrative, Laboratory Tests - Haematology, Laboratory Tests - Blood Chemistry, Laboratory Tests - Urinalysis
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Screening - Toxicities Related to Previous Radiotherapy for SCLC; 12-Lead Electrocardiogram; Diagnostic Studies for Tumor Assessment; Ongoing Medical Conditions Associated with SCLC; Significant Medical/Surgical History and Physical Examination

- 4/17/21 - 1 form, 9 itemgroups, 20 items, 1 language
Itemgroups: Administrative, Toxicities related to previous Radiotherapy for SCLC, Toxicities related to previous Radiotherapy for SCLC, 12-Lead Electrocardiogram, Diagnostic Studies for Tumor Assessment, Ongoing Medical Conditions Associated with SCLC, Ongoing Medical Conditions Associated with SCLC, Significant Medical/ Surgical History and Physical Examination, Significant Medical/ Surgical History and Physical Examination
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Eligibility Metastases of Central Nervous System NCT00831545

- 1/24/16 - 1 form, 2 itemgroups, 19 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Study to Evaluate the Efficacy and Safety of Temozolomide in Subjects With Brain Metastases of Either Malignant Melanoma, Breast, or Non-small Cell Lung Cancer (P02064); ODM derived from: https://clinicaltrials.gov/show/NCT00831545

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