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

- 27/11/2024 - 5 Formulär, 1 Item-grupp, 1 Dataelement, 1 Språk

Item-grupp: 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."

Breast Cancer NCT01306032 Registration - Eligibility/Pre-Registration Worksheet - 3158687v1.0 - Eligibility/Pre-Registration Worksheet

- 09/01/2015 - 1 Formulär, 6 Item-grupper, 61 Dataelement, 1 Språk

Item-grupper: STANDARD PATIENT IDENTIFIER, STANDARD DEMOGRAPHICS (II), INCLUSION CRITERIA, EXCLUSION CRITERIA, Pre Study Evaluations, Laboratory studies will be conducted 1 week prior to starting study drug will include

Eligibility/Pre-Registration Worksheet ABT-888 With Cyclophosphamide in Refractory BRCA-Positive Ovarian, Primary Peritoneal or Ovarian High-Grade Serous Carcinoma, Fallopian Tube Cancer, Triple-Negative Breast Cancer, and Low-Grade Non-Hodgkin's Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=94CE0410-6594-C0F7-E040-BB89AD4342BD

Fallopian Tube Cancer NCT00951496 Treatment - Gynecologic Oncology Group Surgical Status Form - 2305792v3.0 - Gynecologic Oncology Group Surgical Status Form

- 09/01/2015 - 1 Formulär, 7 Item-grupper, 28 Dataelement, 1 Språk

Item-grupper: HEADER MODULE, SURGICAL INFORMATION, FIRST SURGICAL PROCEDURE, SECOND SURGICAL PROCEDURE, THIRD SURGICAL PROCEDURE, FOURTH SURGICAL PROCEDURE, Comments

Gynecologic Oncology Group Surgical Status Form Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F17BE4C4-06A3-1816-E034-0003BA3F9857

NCT00565851 GYNECOLOGIC ONCOLOGY GROUP Surgical Reporting Form - FORM C

- 27/06/2015 - 1 Formulär, 3 Item-grupper, 24 Dataelement, 1 Språk

Item-grupper: Patient demographics, Surgery assessment, Comments

NCT00565851 GYNECOLOGIC ONCOLOGY GROUP Surgical Reporting Form - FORM C Carboplatin and Paclitaxel With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DA3F6FCF-2BF6-2D9B-E034-0003BA12F5E7

Fallopian Tube Cancer NCT00262847 Pathology - GOG-0218 Pathology Form - 2303493v3.0 - GOG-0218 Pathology Form

- 09/01/2015 - 1 Formulär, 4 Item-grupper, 31 Dataelement, 1 Språk

Item-grupper: HEADER MODULE, PRIMARY DISEASE ASSESSMENT, SECONDARY DISEASE ASSESSMENT, FOOTER MODULE

GOG-0218 Pathology Form Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal Cancer, or Fallopian Tube Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F0DFFB93-11B7-4CA5-E034-0003BA3F9857

Fallopian Tube Cancer NCT01081262 Pathology - GOG-0241 Pathology Form (F) - 3126918v1.0 - GOG-0241 Pathology Form (F)

- 09/01/2015 - 1 Formulär, 3 Item-grupper, 28 Dataelement, 1 Språk

Item-grupper: HEADER MODULE, PRIMARY DISEASE ASSESSMENT, SECONDARY DISEASE ASSESSMENT

GOG-0241 Pathology Form (F) Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine, With or Without Bevacizumab, as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II, Stage III, Stage IV, or Recurrent Stage I Epithelial Ovarian Cancer or Fallopian Tube Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8D17F7CB-70DF-90BC-E040-BB89AD435566

Fallopian Tube Cancer NCT00108745 Pathology - Pathology Form, GOG-0212, Form F - 2296111v3.0 - Pathology Form, GOG-0212, Form F

- 09/01/2015 - 1 Formulär, 4 Item-grupper, 31 Dataelement, 1 Språk

Item-grupper: HEADER MODULE, PRIMARY DISEASE ASSESSMENT, SECONDARY DISEASE ASSESSMENT, FOOTER MODULE

Pathology Form, GOG-0212, Form F Paclitaxel or Polyglutamate Paclitaxel or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Peritoneal Cancer or Fallopian Tube Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E74949DE-AB5E-451A-E034-0003BA3F9857

Fallopian Tube Cancer NCT00951496 Pathology - Gynecologic Oncology Group Pathology Form (Form F) - 2834756v1.0 - Gynecologic Oncology Group Pathology Form (Form F)

- 09/01/2015 - 1 Formulär, 3 Item-grupper, 28 Dataelement, 1 Språk

Item-grupper: HEADER MODULE, PRIMARY DISEASE ASSESSMENT, SECONDARY DISEASE ASSESSMENT

Gynecologic Oncology Group Pathology Form (Form F) Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=624516DD-721D-10AB-E040-BB89AD434B50

GYNECOLOGIC ONCOLOGY GROUP Pathology Form - FORM F NCT00565851

- 26/06/2015 - 1 Formulär, 3 Item-grupper, 31 Dataelement, 1 Språk

Item-grupper: Patient demographics, PRIMARY DISEASE ASSESSMENT, SECONDARY DISEASE ASSESSMENT

GYNECOLOGIC ONCOLOGY GROUP Pathology Form - FORM F NCT00565851 Carboplatin and Paclitaxel With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DA4E8FA7-EE6F-210E-E034-0003BA12F5E7

Ovarian Cancer NCT00993655 Pathology - NCIC OV 21 Tumour Tissue Banking Information Report Form - 2874201v1.0 - NCIC OV 21 Tumour Tissue Banking Information Report Form

- 09/01/2015 - 1 Formulär, 2 Item-grupper, 17 Dataelement, 1 Språk

Item-grupper: Patient Information, TUMOUR TISSUE BANKING INFORMATION

NCIC OV 21 Tumour Tissue Banking Information Report Form Comparing Three Combination Chemotherapy Regimens in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=69B794A7-2EA0-1666-E040-BB89AD432FB9

Eligibility Fallopian Tube Cancer NCT01079832

- 21/03/2018 - 1 Formulär, 1 Item-grupp, 11 Dataelement, 1 Språk

Item-grupp: Criteria

Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies; ODM derived from: https://clinicaltrials.gov/show/NCT01079832

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Adverse Events; Serious Adverse Event; Prior and Concomitant Medications

- 03/09/2019 - 1 Formulär, 8 Item-grupper, 61 Dataelement, 1 Språk

Item-grupper: Administrative, Are there any non-serious adverse events to report?, Non-Serious adverse Events, Serious Adverse Event #1, Serious Adverse Event #1 - Relevant Laboratory Data, Serious Adverse Event #1 - Signature, Prior and Concomitant Medications, Prior and Concomitant Medications

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

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