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  1. 1. Clinical Trial
  2. 2. Routine Documentation
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    1. 7.1. Anesthesiology
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dbGaP phs000942 Use of WGS for Diagnosis and Discovery in the Cancer Genetics Clinic - Eligibility

- 11/27/24 - 5 forms, 1 itemgroup, 1 item, 1 language
Itemgroup: IG.elig
Principal Investigator: Theodora S. Ross, MD, PhD, Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX, USA, and Department of Cancer Genetics, UT Southwestern Medical Center, Dallas, TX, USA MeSH: Neoplasms,Breast Neoplasms,Ovarian Neoplasms,Peritoneal Neoplasms,Skin Neoplasms,Esophageal Neoplasms,Thyroid Neoplasms,Urinary Bladder Neoplasms,Endometrial Neoplasms,Fallopian Tube Neoplasms,Melanoma,Testicular Neoplasms,Bile Duct Neoplasms,Lung Neoplasms,Colonic Neoplasms,Adrenocortical Carcinoma,Carcinoma, Renal Cell,Colonic Polyps,Adenomatous Polyposis Coli,Lymphoma, Large B-Cell, Diffuse,Pheochromocytoma,Paraganglioma,Leiomyoma,Hemangioblastoma,Hyperparathyroidism,Pancreatic Neoplasms,Vulvar Neoplasms,Brain Neoplasms,Liver Neoplasms,Kidney Neoplasms,Prostatic Neoplasms,Glioblastoma,Oncocytoma, renal https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000942 Despite the potential of whole-genome sequencing (WGS) to improve patient diagnosis and care, the empirical value of WGS in the cancer genetics clinic is unknown. We performed WGS on members of two cohorts of cancer genetics patients: those with BRCA1/2 mutations (n = 176) and those without (n = 82). Initial analysis of potentially pathogenic variants (PPVs, defined as nonsynonymous variants with allele frequency 1% in ESP6500) in 163 clinically-relevant genes suggested that WGS will provide useful clinical results. This is despite the fact that a majority of PPVs were novel missense variants likely to be classified as variants of unknown significance (VUS). Furthermore, previously reported pathogenic missense variants did not always associate with their predicted diseases in our patients. This suggests that the clinical use of WGS will require large-scale efforts to consolidate WGS and patient data to improve accuracy of interpretation of rare variants. While loss-of-function (LoF) variants represented only a small fraction of PPVs, WGS identified additional cancer risk LoF PPVs in patients with known BRCA1/2 mutations and led to cancer risk diagnoses in 21% of non-BRCA cancer genetics patients after expanding our analysis to 3209 ClinVar genes. These data illustrate how WGS can be used to improve our ability to discover patients' cancer genetic risks. "Reprinted from doi:10.1016/j.ebiom.2014.12.003, with permission from EBioMedicine."

pht004834.v1.p1

1 itemgroup 5 items

pht004835.v1.p1

1 itemgroup 5 items

pht004836.v1.p1

1 itemgroup 16 items

pht004837.v1.p1

1 itemgroup 5 items

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Laboratory Tests (Annex Report 2 Final)

- 10/28/20 - 1 form, 8 itemgroups, 16 items, 1 language
Itemgroups: Administrative, Laboratory Tests, Laboratory Assay, Haematology, Biochemistry, Hepatic Function, Renal Function, HCG Urine or Blood Pregnancy Test
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Laboratory Tests

- 8/25/20 - 1 form, 8 itemgroups, 16 items, 1 language
Itemgroups: Administrative, Laboratory Tests, Laboratory Assay, Haematology, Biochemistry, Hepatic Function, Renal Function, HCG Urine or Blood Pregnancy Test
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Laboratory Reference Ranges, Use of Human Samples by GSK, Investigator's Signature (Report Final and Annex Report 2 Final)

- 11/3/20 - 1 form, 8 itemgroups, 31 items, 1 language
Itemgroups: Administrative, Laboratory Reference Ranges, Laboratory Reference Ranges - Haematology, Laboratory Reference Ranges - Biochemistry, Laboratory Reference Ranges - Hepatic Function, Laboratory Reference Ranges - Renal Function , Use of human samples by GSK, Investigator's Signature
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Check for Study Continuation; Physical Examination; Laboratory Tests (Report Final and Annex Report 2 Final)

- 10/29/20 - 1 form, 43 itemgroups, 93 items, 1 language
Itemgroups: Administrative, Check for Study Continuation (Visit 1), Check for Study Continuation (Visit 2) , Check for Study Continuation (Visit 3) , Check for Study Continuation (Visit 4), Check for Study Continuation (Visit 5) , Check for Study Continuation (Visit 6) , Check for Study Continuation (Visit 7) , Check for Study Continuation (Visit 8) , Check for Study Continuation (Visit 9) , Check for Study Continuation (Visit 10) , Check for Study Continuation (Visit 11) , Check for Study Continuation (Visit 12) , Check for Study Continuation (Visit 13), Check for Study Continuation (Visit 14), Check for Study Continuation (Visit 15) , Check for Study Continuation (Visit 16) , Check for Study Continuation (Visit 17) , Check for Study Continuation (Visit 18) , Check for Study Continuation (Visit 19) , Check for Study Continuation (Visit 20) , Check for Study Continuation (Visit 21) , Check for Study Continuation (Visit 22), Check for Study Continuation (Visit 23) , Check for Study Continuation (Visit 24) , Check for Study Continuation (Visit 25), Check for Study Continuation (Visit 26), Check for Study Continuation (Visit 27), Check for Study Continuation (Visit 28) , Check for Study Continuation (Follow-Up) , Physical Examination (Visit 1), Physical Examination (Visit 2 - 6, 8 - 13, 15 - 18, 20 - 28), Physical Examination (Follow-Up) , Weight (Visit 1 - 6, 8 - 13, 15 - 18, 20 - 28, Follow-Up), Laboratory Tests (Visit 1, 3, 6, 8, 10, 14 - 18, 20 - 28), Haematology (Visit 1, 3, 6, 8, 10, 14 - 18, 20 - 28), Hepatic Function (Visit 1, 3, 6, 8, 10, 14 -18, 21, 23 - 28), Biochemistry (Visit 1, 3, 6, 8, 10, 14 - 18, 21, 23 - 28), Renal Function (Visit 1, 3, 6, 8, 10, 14 - 18, 21, 23 - 28), Humoral Immunity (Serum) (Visit 1, 3, 7, 14, 19, 21, 23 - 28, Follow-Up), Cellular Immunity (PBMC) (Visit 1, 7, 14, 19, 21, 23 - 26, 28, Follow-Up), HCG Urine or Blood Pregnancy Test (Visit 7, 11, 15, 17, 20 - 27), End of follow-up
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

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