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 Fallopian Tube Carcinoma NCT02315469

- 9/20/21 - 1 form, 2 itemgroups, 10 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

Comprehensive Patient Questionnaires in Predicting Complications in Older Patients With Gynecologic Cancer Undergoing Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT02315469

Fallopian Tube Cancer NCT01081262 Eligibility - GOG-0241: Fast Fact Sheet for Protocol 0241 (Ovary, Fallopian Tube) - 3128347v1.0 - GOG-0241: Fast Fact Sheet for Protocol 0241 (Ovary, Fallopian Tube)

- 9/20/21 - 1 form, 5 itemgroups, 76 items, 1 language

Itemgroups: Patient Information, Eligibility 1, Eligibility 2, Eligibility 3, Provide comments about this Fast Fact Sheet

GOG-0241: Fast Fact Sheet for Protocol 0241 (Ovary, Fallopian Tube) 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=8DA7C30C-FD52-1F06-E040-BB89AD430C14

Fallopian Tube Cancer NCT01167712 Pre-Study - GOG-0262: Fast Fact Sheet for Protocol 0262 (Ovary, Fallopian Tube, Primary Peritoneal) - 3110638v1.0 - GOG-0262: Fast Fact Sheet for Protocol 0262 (Ovary, Fallopian Tube, Primary Peritoneal)

- 9/20/21 - 1 form, 6 itemgroups, 81 items, 1 language

Itemgroups: Patient Information, Eligibility 1, Eligibility 2, Eligibility 3, Eligibility 4, Provide comments about this Fast Fact Sheet

GOG-0262: Fast Fact Sheet for Protocol 0262 (Ovary, Fallopian Tube, Primary Peritoneal) Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, 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=893B4E4E-209D-97F3-E040-BB89AD4371DB

Ovarian Cancer NCT00993655 Treatment - NCIC OV 21 Treatment Report Form - 2874225v1.0 - NCIC OV 21 Treatment Report Form

- 9/20/21 - 1 form, 30 itemgroups, 129 items, 1 language

Itemgroups: Patient Information, TIMING OF REPORT, PHYSICAL EXAM, SYSTEMIC THERAPY REPORT, STUDY DRUG ADMINISTRATION - PACLITAXEL, DOSE MODIFICATION TABLE - PACLITAXEL, GFR for Carboplatin dose calculation, STUDY DRUG ADMINISTRATION - CARBOPLATIN, DOSE MODIFICATION TABLE - CARBOPLATIN, STUDY DRUG ADMINISTRATION - CISPLATIN, DOSE MODIFICATION TABLE - CISPLATIN, HOSPITALIZATION, GROWTH FACTORS, SURGERY, ANTI-CANCER TREATMENT, HEMATOLOGY , BIOCHEMISTRY, RESPONSE ASSESSMENT - QUESTION 2, TARGET LESIONS, NON-TARGET LESIONS DURING TREATMENT, NEW LESIONS, OTHER RADIOLOGY, ADVERSE EVENTS / INTERCURRENT ILLNESS, IP Administration -- questions, Day 1 IP Administration, CONCOMITANT MEASURES/MEDICATIONS, MAJOR MEDICAL PROBLEMS, QUALITY OF LIFE QUESTIONNAIRE, Comments, Contact Information

NCIC OV 21 Treatment 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=69B8C40D-B835-E610-E040-BB89AD43211A

Fallopian Tube Cancer NCT01167712 Quality of Life - GOG-0262: Quality of Life Survey Form - 2917772v1.0 - GOG-0262: Quality of Life Survey Form

- 9/20/21 - 1 form, 6 itemgroups, 37 items, 1 language

Itemgroups: Header Module, PHYSICAL WELLBEING, FUNCTIONAL WELLBEING, Additional Concerns, FACT/GOG-Ntx Subscale, To be Completed by Clinical Staff

GOG-0262: Quality of Life Survey Form Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, 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=6E5EDF6F-8906-E23E-E040-BB89AD435A10

Fallopian Tube Cancer NCT01081262 Quality of Life - GOG-0241 Quality of Life Survey Form - 3126513v1.0 - GOG-0241 Quality of Life Survey Form

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

Itemgroups: Header Module, QOL Questionnaire Administration, PHYSICAL WELLBEING, FUNCTIONAL WELLBEING, Additional Concerns, FACT/GOG-Ntx Subscale, EQ-5D Health State Measurement, Health State, To be Completed by Clinical Staff

GOG-0241 Quality of Life Survey Form 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=8D16EFA4-532E-082B-E040-BB89AD434B01

GOG-0255: Fast Fact Sheet for Protocol 0255 (Ovary) NCT00857545

- 9/20/21 - 1 form, 4 itemgroups, 52 items, 1 language

Itemgroups: Patient demographics, Miscellaneous Patient Information, Lab Results, Provide comments about this Fast Fact Sheet

GOG-0255: Fast Fact Sheet for Protocol 0255 (Ovary) NCT00857545 OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8AD3D0D0-DD90-47BC-E040-BB89AD43777A

Fallopian Tube Cancer NCT01305213 Pre-Study - Fast Fact Sheet for Protocol 0186-I (Ovary) - 3190753v1.0 - Fast Fact Sheet for Protocol 0186-I (Ovary)

- 9/17/21 - 1 form, 3 itemgroups, 93 items, 1 language

Itemgroups: Patient Information, Eligibility 1, Provide comments about this Fast Fact Sheet

Fast Fact Sheet for Protocol 0186-I (Ovary) Bevacizumab With or Without Fosbretabulin Tromethamine in Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9BF343E9-48AD-0577-E040-BB89AD437EA3

Fallopian Tube Cancer NCT00108745 Lab - Specimen Form, GOG-0212, Form SP - 2297741v3.0 - Specimen Form, GOG-0212, Form SP

- 9/17/21 - 1 form, 7 itemgroups, 55 items, 1 language

Itemgroups: HEADER MODULE, SITE CONTACT INFORMATION, GENERAL SPECIMEN INFORMATION, BLOOD/FLUID PRODUCTS, TISSUE/CELLS, GOG TISSUE BANK/LABORATORY INFORMATION, FOOTER MODULE

Specimen Form, GOG-0212, Form SP 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=E79A185F-51CE-71A1-E034-0003BA3F9857

Fallopian Tube Cancer NCT00262847 Lab - GOG-0218 Specimen Form - 2303734v3.0 - GOG-0218 Specimen Form

- 9/17/21 - 1 form, 7 itemgroups, 55 items, 1 language

Itemgroups: HEADER MODULE, SITE CONTACT INFORMATION, GENERAL SPECIMEN INFORMATION, BLOOD/FLUID PRODUCTS, TISSUE/CELLS, GOG TISSUE BANK/LABORATORY INFORMATION, FOOTER MODULE

GOG-0218 Specimen 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=F0E16A95-3A2C-5BBD-E034-0003BA3F9857

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Survival Information; Form D; Termination Record

- 9/3/19 - 1 form, 9 itemgroups, 29 items, 1 language

Itemgroups: Survival Information - Month of Report, Survival Information - Review of disease status, Survival Information - Outcome, Form D, Termination Record, Termination Record - Review of Disease Status, Termination Record - Best Overall Response, Termination Record - Study Conclusion, Termination Record - Investigator Signature

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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