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Relevancia Evaluación Nuevo primero Antiguo primero

dbGaP phs001179 Foundation Medicine Adult Cancer Clinical Dataset (FM-AD) - Eligibility

- 29/5/23 - 3 formularios, 1 itemgroup, 1 item, 1 idioma
Itemgroup: IG.elig
Principal Investigator: Doron Lipson, PhD, Foundation Medicine Inc., Cambridge, MA, USA MeSH: Neoplasms,Thoracic Neoplasms,Digestive System Neoplasms,Breast Neoplasms,Urogenital Neoplasms,Endocrine Gland Neoplasms,Nervous System Neoplasms,Skin Neoplasms,Head and Neck Neoplasms,Abdominal Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001179 The Foundation Medicine adult cancer clinical dataset consists of 18,004 unique solid tumor samples that underwent genomic profiling on a single uniform platform as part of standard clinical care. The dataset is derived from the FoundationOne® genomic profiling assay version 2 that interrogates exonic regions of 287 cancer-related genes and selected introns from 19 genes known to undergo rearrangements in human cancer. Genomic DNA samples were sequenced to over 500x median coverage, and custom computational analyses identified all classes of genomic alterations (base substitutions, insertions and deletions, copy number alterations, and rearrangements). Since matched normal tissue was unavailable for analysis, these data underwent additional filtering to enrich for cancer-related events. The reported data includes genomic alterations that are known and suspected tumor drivers, as well as variants of unknown significance. To preserve patient anonymity, all known or suspected germline variants were removed from the data unless known to be associated with cancer development. The dataset contains genomic alteration profiles generated by FoundationOne version 2 testing for adult cancer patients (over 18 y.o.), and represents a vast diversity of tumor subtypes, including many rare diseases not profiled as part of large-scale profiling efforts. Cases are grouped into 16 broad disease categories containing tumors from 162 unique disease subtypes. Since specimens were profiled as part of clinical care, limited clinical parameters were available, including age, gender, tissue of origin, % of tumor nuclei, and diagnosis. Publication of this dataset is intended to allow the broad scientific community access to this unique cohort for use in scientific research projects of common and rare types of cancer, both for generating leads regarding causal mechanisms as well as cross-testing and confirming existing hypotheses. A pediatric cancer clinical dataset consisting of data from 1,215 patients under 18 y.o. is available separately at: FOUNDATION MEDICINE

pht005673.v1.p1

1 itemgroup 2 items

pht005668.v1.p1

1 itemgroup 2 items

dbGaP phs001202 OncoArray: Oral and Pharynx Cancer - pht005773.v1.p1

- 22/5/23 - 5 formularios, 1 itemgroup, 5 items, 1 idioma
Itemgroup: pht005773
Principal Investigator: Paul Brennan, PhD, International Agency for Research on Cancer (IARC), Lyon, France MeSH: Head and Neck Neoplasms,Mouth Neoplasms,Pharyngeal Neoplasms,Oropharyngeal Neoplasms,Hypopharyngeal Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001202 Genetic factors play an important role in susceptibility to head and neck cancer and could also explain differences in response to treatment and outcome. The goal of this project is to investigate genetic variation involved in oral and oropharyngeal cancer susceptibility by performing the largest GWAS on these diseases, using a novel genotyping tool specifically designed for cancer studies by the OncoArray Network. This project encompasses data from approximately 6000 oral and pharynx cancer cases and 4000 controls derived from 12 epidemiological studies most of case-control design. The genotyping was centralized at the Center for Inherited Disease Research (CIDR), and the epidemiological data harmonization and analysis were completed at the International Agency for Research on Cancer (IARC). This study was supported by National Institute of Dental and Craniofacial Research (NIDCR) with direct funding to CIDR.

pht005774.v1.p1

1 itemgroup 5 items

pht005775.v1.p1

1 itemgroup 8 items

Eligibility

1 itemgroup 1 item

pht005776.v1.p1

1 itemgroup 6 items

dbGaP phs000370 The Mutational Landscape of Head and Neck Squamous Cell Carcinoma - pht002381.v1.p1

- 12/10/22 - 4 formularios, 1 itemgroup, 2 items, 1 idioma
Itemgroup: pht002381
Principal Investigator: Todd Golub, Broad Institute, Cambridge, MA and Dana Farber Cancer Institute, Boston, MA, USA MeSH: Head and Neck Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000370 This study was the first-known large-scale effort to uncover the mutational spectrum of head and neck cancers. We analyzed whole-exome sequence from 92 tumor-normal pairs and retained 74 of them for significance analysis. The majority exhibited a mutational profile consistent with tobacco exposure; human papilloma virus sequence was detectable in 15% of cases. In addition to identifying previously known HNSCC genes (*TP53, CDKN2A, PTEN, PIK3CA, and HRAS*), the analysis revealed many genes not previously implicated in this malignancy. At least 30% of cases harbor mutations in genes (such as *NOTCH1, IRF6, TP63*) that regulate squamous differentiation, implicating alterations in this process as a major driver of HNSCC carcinogenesis. Altogether, the results suggest that large-scale exome sequencing may illuminate fundamental tumorigenic mechanisms with important therapeutic implications.

pht002383.v1.p1

1 itemgroup 9 items

pht002384.v1.p1

1 itemgroup 7 items

pht002382.v2.p1

1 itemgroup 3 items

Eligibility Carcinoma, Squamous Cell NCT00671437

- 27/9/21 - 1 formulario, 2 itemgroups, 12 items, 1 idioma
Itemgroups: Inclusion Criteria, Exclusion Criteria
Determine Tumor Response Using Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) Before and After Cetuximab in Patients With Head and Neck Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00671437

Eligibility Carcinoma, Squamous Cell of the Head and Neck NCT00753038

- 27/9/21 - 1 formulario, 2 itemgroups, 16 items, 1 idioma
Itemgroups: Inclusion Criteria, Exclusion Criteria
Phase 2 Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Head and Neck Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00753038

NCT00113399 RTOG-0421 HP: Radiation Therapy Oncology Group Health Utility Measurement Euro (EQ-5D) Miscellaneous Patient Assessment Form

- 20/9/21 - 1 formulario, 2 itemgroups, 23 items, 1 idioma
Itemgroups: RTOG clinical trial administrative data, Miscellaneous Patient Assessment
NCT00113399 RTOG-0421 HP: Radiation Therapy Oncology Group Health Utility Measurement Euro (EQ-5D) Miscellaneous Patient Assessment Form Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EBAEDD99-A13F-1374-E034-0003BA3F9857

RTOG 0920 Phase III Head and Neck Cancer Health Utility Measurement Euro QOL (EQ-5D) Form (HP)

- 20/9/21 - 1 formulario, 4 itemgroups, 38 items, 1 idioma
Itemgroups: Header Module, QOL Cover Sheet, Health Utility Measurement, Header
RTOG 0920 Phase III Head and Neck Cancer Health Utility Measurement Euro QOL (EQ-5D) Form (HP) Radiation Therapy With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5D3C3F4A-8C30-21E8-E044-0003BA3F9857

RTOG-0522 HP: Radiation Therapy Oncology Group Miscellaneous Patient Assessment Form NCT00265941

- 20/9/21 - 1 formulario, 2 itemgroups, 28 items, 1 idioma
Itemgroups: RTOG clinical trial administrative data, Miscellaneous Patient Assessment
RTOG-00522 HP: Radiation Therapy Oncology Group Miscellaneous Patient Assessment Form NCT00265941 Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F5E8260F-4AEB-157F-E034-0003BA3F9857

E1305 On-Study Form NCT00588770

- 20/9/21 - 1 formulario, 9 itemgroups, 71 items, 1 idioma
Itemgroups: Header, Data amendment, Patient Information, Cardiac History, Prior Treatment for Disease, Disease Status at Initial Diagnosis, Disease Status at Time of Study Entry, Baseline Abnormalities, Footer Module
E1305 On-Study Form NCT00588770 Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1A0A6D56-A371-47E3-E044-0003BA3F9857

Initial Evaluation Head and Neck Cancer Stage III or IV RTOG-0522 I1 NCT00265941

- 20/9/21 - 1 formulario, 9 itemgroups, 79 items, 1 idioma
Itemgroups: Header, Patient demographics, PRIOR TREATMENT, COMORBIDITY, DIAGNOSTIC WORK-UP, LABORATORY TESTS, TUMOR MEASUREMENTS AT PRESENTATION, Protocol Specific Adverse Event Evaluation, COMMENTS
RTOG-0522 I1: Initial Evaluation Form NCT00265941 Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F64A912E-BA2D-250A-E034-0003BA3F9857

Initial Evaluation recurrent Head and Neck Cancer RTOG NCT00113399

- 20/9/21 - 1 formulario, 2 itemgroups, 69 items, 1 idioma
Itemgroups: Header, COMMENTS
Radiation Therapy Oncology Group Follow-up Form Phase III Recurrent Head and Neck Study Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EC4F6FCB-F88D-02BE-E034-0003BA3F9857

Pre-Study Form Head and Neck Cancer Phase III RTOG 0920 I1 NCT00956007

- 20/9/21 - 1 formulario, 12 itemgroups, 102 items, 1 idioma
Itemgroups: Header Module, Patient demographics, Swallowing problems/Smoking history, DIAGNOSTIC WORK-UP, Laboratory Values, Primary Site, Staging, Surgery and Pathologic Risk Factors, PRIOR TREATMENT, SEVERE ACTIVE COMORBIDITIES, Protocol Specific Adverse Event Evaluation, Footer Module
NCT00956007 RTOG 0920 Phase III Head and Neck Cancer Initial Evaluation Form (I1) Radiation Therapy With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5D3AD2F7-ECBD-0ECD-E044-0003BA3F9857

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