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  1. 1. Ensayo clínico
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dbGaP phs000495 The Gene Partnership (TGP) - eMERGE Data - Eligibility

- 13/12/22 - 5 moduli, 1 ItemGroup, 7 elementi, 1 linguaggio
ItemGroup: IG.elig
Principal Investigator: Isaac S. Kohane, MD, PhD, Boston Children's Hospital, Boston, MA, USA MeSH: Autistic Disorder,Heart Defects, Congenital,Asthma,Attention Deficit Disorders,Diabetes Mellitus, Type 1,Diabetes Mellitus, Type 2,Epilepsy,Gastrointestinal Diseases,Hypersensitivity,Autoimmune Diseases,Hematologic Diseases,Neoplasms,Arrhythmias, Cardiac,Chromosome Aberrations,Congenital Abnormalities,Dermatology,Developmental Disabilities,Endocrine System,Otolaryngology,Syndrome,Urogenital System,Hearing Loss,Immune System Diseases,Musculoskeletal Abnormalities,Nervous System Diseases,Neuromuscular Diseases,Metabolic Diseases,Nutrition Disorders,Vision Disorders,Mouth Diseases,Mental Disorders,Kidney Diseases,Respiration Disorders,Thyroid Diseases,Vascular Diseases https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000495 The Gene Partnership (TGP) is a prospective longitudinal registry at Boston Children's Hospital (BCH) to study the genetic and environmental contributions to childhood health and disease, collect genetic information on a large number of children who have been phenotyped, and implement the Informed Cohort and the Informed Cohort Oversight Board (ICOB). The term "*The Gene Partnership*" reflects a partnership between researchers and participants. Children seen at BCH are offered enrollment, as are their parents and siblings. DNA is collected on all enrollees. BCH has a comprehensive EMR system, and virtually all inpatient and outpatient data are captured electronically. Clinical data in the BCH EMR is loaded in the i2b2 data warehouse which is available to investigators. Cases, phenotypes, and covariates are ascertained using the i2b2 database. Participants at BCH in TGP have consented to receive any research result and/or incidental finding that arises from studies using TGP that is approved by the Informed Cohort Oversight Board (ICOB) and is in accordance with the participants' preferences; results are returned through the Personally Controlled Health Record (PCHR). BCH and Cincinnati Children's Hospital Medical Center (CCHMC) have partnered as the *P*ediatric *A*lliance for *G*enomic and *E*lectronic Medical Record (EMR) *R*esearch (*PAGER*) site for the eMERGE Phase II network for pediatric institutions, and the cohort for eMERGE at BCH is TGP.

pht002864.v1.p1

1 ItemGroup 4 elementi

pht002865.v1.p1

1 ItemGroup 5 elementi

pht002866.v1.p1

1 ItemGroup 42 elementi

pht002867.v1.p1

1 ItemGroup 4 elementi

Eligibility Melanoma NCT00147550

- 19/10/16 - 1 modulo, 2 itemgroups, 16 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
MEK Inhibitor PD-325901 To Treat Advanced Breast Cancer, Colon Cancer, And Melanoma.; ODM derived from: https://clinicaltrials.gov/show/NCT00147550

Eligibility Metastatic or Recurrent Squamous Cell Carcinoma of the Lung NCT00998192

- 21/6/18 - 1 modulo, 2 itemgroups, 15 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung; ODM derived from: https://clinicaltrials.gov/show/NCT00998192

Eligibility Squamous Cell Esophageal Carcinoma NCT01216527

- 2/11/18 - 1 modulo, 2 itemgroups, 14 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Phase III Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Squamous Cell Esophageal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01216527

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - IMD Report - Scleroderma or Morphea; Dermatomyositis or Polymyositis; Diabetes mellitus Type I (Report Final and Annex Report 2 Final)

- 2/11/20 - 1 modulo, 25 itemgroups, 95 elementi, 1 linguaggio
Itemgroups: Administrative, Scleroderma or Morphea, Scleroderma or Morphea - Signs and Symptoms, Scleroderma or Morphea - Other signs and symptoms, Scleroderma or Morphea - Other signs and symptoms , Scleroderma or Morphea - Diagnostic Test Results, Scleroderma or Morphea - Other Diagnostic Test Results , Scleroderma or Morphea - Other Diagnostic Test Results , Scleroderma or Morphea - Other diagnostic Procedure, Dermatomyositis or Polymyositis, Dermatomyositis or Polymyositis - Signs and symptoms (supporting the final diagnosis), Dermatomyositis or Polymyositis - Other Signs and symptoms, Dermatomyositis or Polymyositis - Other Signs and symptoms , Dermatomyositis or Polymyositis - Diagnostic Test Results, Dermatomyositis or Polymyositis - Other Diagnostic Test Results , Dermatomyositis or Polymyositis - Other Diagnostic Test Results , Dermatomyositis or Polymyositis - Other diagnostic Procedure , Diabetes mellitus type I, Diabetes mellitus type I - Signs and symptoms (supporting the final diagnosis), Diabetes mellitus type I - Other Signs and symptoms , Diabetes mellitus type I - Other Signs and symptoms , Diabetes mellitus type I - Diagnostic Test Results , Diabetes mellitus type I - Other Diagnostic Test Results , Diabetes mellitus type I - Other Diagnostic Test Results , Diabetes mellitus type I - Other diagnostic Procedure
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 - IMD Report - Autoimmune Liver Diseases; Sarcoidosis; Other diseases (Report Final and Annex Report 2 Final)

- 3/11/20 - 1 modulo, 23 itemgroups, 85 elementi, 1 linguaggio
Itemgroups: Administrative, Autoimmune Liver Diseases, Autoimmune Liver Diseases - Signs and Symptoms, Autoimmune Liver Diseases - Other signs and symptoms, Autoimmune Liver Diseases - Other signs and symptoms , Autoimmune Liver Diseases - Diagnostic Test Results, Autoimmune Liver Diseases - Other Diagnostic Test Results , Autoimmune Liver Diseases - Other Diagnostic Test Results , Autoimmune Liver Diseases - Other diagnostic Procedure, Sarcoidosis, Sarcoidosis - Signs and symptoms, Sarcoidosis - Other Signs and symptoms, Sarcoidosis - Other Signs and symptoms , Sarcoidosis - Diagnostic Test Results, Sarcoidosis - Other Diagnostic Test Results , Sarcoidosis - Other Diagnostic Test Results , Sarcoidosis - Other diagnostic Procedure , Other disease, Other disease - Signs and symptoms, Other disease - Diagnostic Test Results , Other disease - Other Diagnostic Test Results , Other disease - Other Diagnostic Test Results , Other disease - Other diagnostic Procedure
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 - IMD Report - Idiopathic Thrombocytopenic Purpura; Pernicious Anaemia; Vasculitis (Report Final and Annex Report 2 Final)

- 3/11/20 - 1 modulo, 25 itemgroups, 91 elementi, 1 linguaggio
Itemgroups: Administrative, Idiopathic Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura - Signs and Symptoms, Idiopathic Thrombocytopenic Purpura - Other signs and symptoms, Idiopathic Thrombocytopenic Purpura - Other signs and symptoms , Idiopathic Thrombocytopenic Purpura - Diagnostic Test Results, Idiopathic Thrombocytopenic Purpura - Other Diagnostic Test Results , Idiopathic Thrombocytopenic Purpura - Other Diagnostic Test Results , Idiopathic Thrombocytopenic Purpura - Other diagnostic Procedure, Pernicious Anaemia, Pernicious Anaemia - Signs and symptoms, Pernicious Anaemia - Other Signs and symptoms, Pernicious Anaemia - Other Signs and symptoms , Pernicious Anaemia - Diagnostic Test Results, Pernicious Anaemia - Other Diagnostic Test Results , Pernicious Anaemia - Other Diagnostic Test Results , Pernicious Anaemia - Other diagnostic Procedure , Vasculitis, Vasculitis - Signs and symptoms, Vasculitis - Other Signs and symptoms , Vasculitis - Other Signs and symptoms , Vasculitis - Diagnostic Test Results , Vasculitis - Other Diagnostic Test Results , Vasculitis - Other Diagnostic Test Results (i.e. Serological viral hepatic tests, Serological liver enzymes), Vasculitis - Other diagnostic Procedure
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 (Annex Report 2 Final)

- 28/10/20 - 1 modulo, 8 itemgroups, 16 elementi, 1 linguaggio
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

- 25/8/20 - 1 modulo, 8 itemgroups, 16 elementi, 1 linguaggio
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)

- 3/11/20 - 1 modulo, 8 itemgroups, 31 elementi, 1 linguaggio
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)

- 29/10/20 - 1 modulo, 43 itemgroups, 93 elementi, 1 linguaggio
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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