Search results - Portal of Medical Data Models (MDM-Portal)

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."

Eligibility NCT00655252 Metastatic Renal Cell Cancer - Eligibility

- 12/9/13 - 1 form, 2 itemgroups, 10 items, 2 languages

Itemgroups: Inclusion Criteria, Exclusion Criteria

ODM derived from http://clinicaltrials.gov/show/NCT00655252

Kidney Cancer NCT01198158 Registration - CALGB 90802 Registration Worksheet Form - 3103555v1.0 - CALGB 90802 Registration Worksheet Form

- 9/20/21 - 1 form, 10 itemgroups, 44 items, 1 language

Itemgroups: Header Module, Protocol Administration, Patient Demographics/Pre-Treatment Characteristics1, Patient Demographics/Pre-Treatment Characteristics2, Patient Demographics/Pre-Treatment Characteristics3, Certification Of Eligibility, Protocol Design, Initial Patient Consent For Specimen Use, CALGB 580902, Registration Information

CALGB 90802 Registration Worksheet Form Everolimus With or Without Bevacizumab in Treating Patients With Advanced Kidney Cancer That Progressed After First-Line Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=879626AD-DB8C-4AF2-E040-BB89AD4364E1

E2805 Renal Cell Carcinoma On-Study Form NCT00326898

- 9/20/21 - 1 form, 9 itemgroups, 50 items, 1 language

Itemgroups: Header, Data amendment, Patient demographics, History of Disease, Description of Primary Disease, Description of Current Disease, Current Disease Symptoms, MUGA Scanning, Footer Module

E2805 Renal Cell Carcinoma On-Study Form NCT00326898 Sunitinib or Sorafenib in Treating Patients With Kidney Cancer That Was Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=053ADDEA-1681-66BC-E044-0003BA3F9857

Kidney Cancer NCT01120249 Response - Southwest Oncology Group S0931 Recurrence Assessment Form (Form #46940) - 2998562v1.0 - Southwest Oncology Group S0931 Recurrence Assessment Form (Form #46940)

- 9/20/21 - 1 form, 4 itemgroups, 24 items, 1 language

Itemgroups: Header Module, Clinical Assessment, Notice of Recurrence, COMMENTS

Southwest Oncology Group S0931 Recurrence Assessment Form (Form #46940) Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7E26385C-8CD8-C34F-E040-BB89AD434A8D

E2805 Material Submission Form NCT00326898

- 9/20/21 - 1 form, 6 itemgroups, 31 items, 1 language

Itemgroups: Header, Patient demographics, Biopsy specimen / Lab, Completed by Central Lab, Contacts, Comments

E2805 Material Submission Form NCT00326898 Sunitinib or Sorafenib in Treating Patients With Kidney Cancer That Was Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=05B6F9C4-7323-1449-E044-0003BA3F9857

Kidney Cancer NCT00326898 Treatment - E2805 Concomitant Medication Form - 2444090v1.0 - E2805 Concomitant Medication Form

- 7/14/17 - 1 form, 3 itemgroups, 34 items, 1 language

Itemgroups: Administrative documentation, Concomitant medication, Comments

E2805 Concomitant Medication Form Sunitinib or Sorafenib in Treating Patients With Kidney Cancer That Was Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0B593E1B-ACB3-37BB-E044-0003BA3F9857

E2805 Adverse Event Form - (CTCAE v3) NCT00326898

- 7/8/15 - 1 form, 11 itemgroups, 51 items, 1 language

Itemgroups: Header, Patient demographics, Data amendment, ON TREATMENT, OFF TREATMENT, Adverse Event Current Assessment, BLOOD/BONE MARROW/METABOLIC - LABS, NON-HEMATOLOGIC, II. INFECTIONS, Other Adverse Events, Comments

E2805 Adverse Event Form - (CTCAE v3) NCT00326898 Sunitinib or Sorafenib in Treating Patients With Kidney Cancer That Was Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0538F350-3C05-47A5-E044-0003BA3F9857

E2805 Surgery Form NCT00326898

- 6/16/15 - 1 form, 8 itemgroups, 48 items, 1 language

Itemgroups: Header, Patient demographics, Data amendment, Section I - Surgery and Staging, Pathologic Tumor Staging, Section II - Surgical Complications, Section III - Lymph Node Dissection, Footer

E2805 Surgery Form NCT00326898 Sunitinib or Sorafenib in Treating Patients With Kidney Cancer That Was Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=053C633F-4176-6FE5-E044-0003BA3F9857

E2805 Second Primary Form NCT00326898

- 6/16/15 - 1 form, 4 itemgroups, 18 items, 1 language

Itemgroups: Header, Patient demographics, Second primary cancer assessment, Footer module

E2805 Second Primary Form NCT00326898 Sunitinib or Sorafenib in Treating Patients With Kidney Cancer That Was Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=054BADA9-3263-36C2-E044-0003BA3F9857

E2805 Non-Protocol Therapy Form NCT00326898

- 6/16/15 - 1 form, 4 itemgroups, 25 items, 1 language

Itemgroups: Header, Patient demographics, Off-protocol treatment, Comments

E2805 Non-Protocol Therapy Form NCT00326898 Sunitinib or Sorafenib in Treating Patients With Kidney Cancer That Was Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=054A9BCE-D49E-2448-E044-0003BA3F9857

E2805 Treatment Form NCT00326898

- 6/8/15 - 1 form, 12 itemgroups, 65 items, 1 language

Itemgroups: Header, Patient demographics, Data amendment, Section I - Vital Status, Section II - Patient Characteristics, Section III - Therapy Administered, Dose Modifications, Assessment of medication, Dose Modifications, Section IV - Blood Pressure, MUGA Scanning, Section VI - Non-Protocol Therapy

E2805 Treatment Form NCT00326898 Sunitinib or Sorafenib in Treating Patients With Kidney Cancer That Was Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=054B80EC-08C8-3374-E044-0003BA3F9857

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