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Initial Evaluation Form Esophageal Cancer RTOG NCT00655876

- 04-08-15 - 1 Formulier, 8 Itemgroepen, 67 Data-elementen, 1 Taal
Itemgroepen: MODULE 1, Patient status assessment, Prior Treatment, Study Cancer, Laboratory Tests, Diagnosis Work-up, Co-Morbidties, Footer
Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2A16F93C-C68B-2E25-E044-0003BA3F9857

dbGaP phs000942 Use of WGS for Diagnosis and Discovery in the Cancer Genetics Clinic - Eligibility

- 27-11-24 - 5 Formulieren, 1 Itemgroep, 1 Data-element, 1 Taal
Itemgroep: 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 Itemgroep 5 Data-elementen

pht004835.v1.p1

1 Itemgroep 5 Data-elementen

pht004836.v1.p1

1 Itemgroep 16 Data-elementen

pht004837.v1.p1

1 Itemgroep 5 Data-elementen

On-Study - Esophageal Cancer - Adjuvant On-Study Form - 2020201v2.31 - Esophageal Cancer - Adjuvant On-Study Form

- 08-01-15 - 1 Formulier, 4 Itemgroepen, 26 Data-elementen, 1 Taal
Itemgroepen: CRF Header, ESOPHAGEAL: FORM ADMINISTRATION, ESOPHAGEAL: ADJUVANT DISEASE DESCRIPTION, ESOPHAGEAL: ADJUVANT PRIOR TREATMENT
Esophageal Cancer - Adjuvant On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99CD59C5-A9A2-3FA4-E034-080020C9C0E0

On-Study - Esophageal Cancer - Advanced On-Study Form - 2020202v2.31 - Esophageal Cancer - Advanced On-Study Form

- 08-01-15 - 1 Formulier, 4 Itemgroepen, 30 Data-elementen, 1 Taal
Itemgroepen: CRF Header, ESOPHAGEAL: FORM ADMINISTRATION, ESOPHAGEAL: ADVANCED DISEASE DESCRIPTION, ESOPHAGEAL: ADVANCED PRIOR TREATMENT
Esophageal Cancer - Advanced On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99CD59C5-A9A4-3FA4-E034-080020C9C0E0

Esophageal Cancer NCT00655876 Demographic - A0 HQ Confirmation - 2904861v1.0 - A0 HQ Confirmation

- 17-09-21 - 1 Formulier, 1 Itemgroep, 29 Data-elementen, 1 Taal
Itemgroep: Patient Information
A0 HQ Confirmation - PHASE III ESOPHAGEAL: RT/PACLITAXEL/CISPLATIN +/ Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6D4170C3-6E1D-4980-E040-BB89AD435BA5

Esophageal Cancer NCT00757172 Registration - ACOSOG-Z4051 Registration Worksheet - 2921081v1.0 - ACOSOG-Z4051 Registration Worksheet

- 09-01-15 - 1 Formulier, 8 Itemgroepen, 80 Data-elementen, 1 Taal
Itemgroepen: Header Module, Eligibility Criteria, Smoking Status, Laboratory Values, Pregnancy Test, Pre-Treatment Staging, Pre-Treatment Staging1, Pre-treatment clinical disease stage (CT, PET, EUS)
ACOSOG-Z4051 Registration Worksheet Panitumumab, Docetaxel, Cisplatin, Radiation Therapy, and Surgery in Treating Patients With Newly Diagnosed, Locally Advanced Esophageal Cancer or Cancer of the Gastroesophageal Junction Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6F3CD617-2357-8015-E040-BB89AD43783A

Esophageal Cancer NCT00551759 Eligibility - E2205 Registration Worksheet (step 1) - 2753343v1.0 - E2205 Registration Worksheet (step 1)

- 17-09-21 - 1 Formulier, 2 Itemgroepen, 34 Data-elementen, 1 Taal
Itemgroepen: Eligibility, Demographic Data Required For Patient Registration
E2205 Registration Worksheet (step 1) Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4E4AEBDF-A595-00B2-E044-0003BA3F9857

Esophageal Cancer NCT00757172 Registration - ACOSOG-Z4051 OPEN Registration Worksheet - 3013492v1.0 - ACOSOG-Z4051 OPEN Registration Worksheet

- 17-09-21 - 1 Formulier, 4 Itemgroepen, 65 Data-elementen, 1 Taal
Itemgroepen: Demography Section, General Information, Eligibility Checklist, Specimen Banking Consent
ACOSOG-Z4051 OPEN Registration Worksheet Panitumumab, Docetaxel, Cisplatin, Radiation Therapy, and Surgery in Treating Patients With Newly Diagnosed, Locally Advanced Esophageal Cancer or Cancer of the Gastroesophageal Junction Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7FFA1514-8109-A58F-E040-BB89AD4376E5

Esophageal Cancer NCT00052910 Toxicity - CALGB: 80101 Late RT Morbidity Report Form - 2078927v3.0 - CALGB: 80101 Late RT Morbidity Report Form

- 09-01-15 - 1 Formulier, 1 Itemgroep, 20 Data-elementen, 1 Taal
Itemgroep: CCRR MODULE
CALGB: 80101 Late RT Morbidity Report Form Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B4D51146-81F5-2F1A-E034-0003BA12F5E7

Esophageal Cancer NCT00655876 Treatment - CS: Radiation Therapy Oncology Group Phase III Esophagus Cover Sheet - 2620609v1.0 - CS: Radiation Therapy Oncology Group Phase III Esophagus Cover Sheet

- 09-01-15 - 1 Formulier, 3 Itemgroepen, 23 Data-elementen, 1 Taal
Itemgroepen: MODULE 1, Cover Sheet, FOOTER MODULE
CS: Radiation Therapy Oncology Group Phase III Esophagus Cover Sheet Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2CD0D9D5-DF0D-1CE5-E044-0003BA3F9857

Esophageal Cancer NCT00655876 Treatment - T1: Radiation Therapy Oncology Group Phase III Esophagus Radiotherapy Form - 2602016v1.0 - T1: Radiation Therapy Oncology Group Phase III Esophagus Radiotherapy Form

- 09-01-15 - 1 Formulier, 1 Itemgroep, 20 Data-elementen, 1 Taal
Itemgroep: MODULE 1
T1: Radiation Therapy Oncology Group Phase III Esophagus Radiotherapy Form Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2A160E28-BC2A-4E10-E044-0003BA3F9857

Esophageal Cancer NCT00655876 Treatment - TF: Radiation Therapy Oncology Group Phase III Esophagus Systemic Treatment Summary Form - 2598533v1.0 - TF: Radiation Therapy Oncology Group Phase III Esophagus Systemic Treatment Summary Form

- 27-09-21 - 1 Formulier, 6 Itemgroepen, 56 Data-elementen, 1 Taal
Itemgroepen: MODULE 1, Summary of Systemic Treatment, Summary of Systemic Treatment, Protocol Specific Adverse Events Evaluation, REPORT ALL CONTINUING OR NEW ADVERSE EVENTS, Footer
TF: Radiation Therapy Oncology Group Phase III Esophagus Systemic Treatment Summary Form Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2A02FE34-6EF5-5B5C-E044-0003BA3F9857

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