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Breast Cancer NCT00433589 Treatment - Endocrine therapy - 2498727v1.0 - Endocrine therapy

- 09/01/15 - 1 Formulaire, 3 Groupes Item, 14 Eléments de données, 1 Langue
Groupes Item: Header, Endocrine therapy, Footer Module
Endocrine therapy Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=19677A9A-FFBD-2E6F-E044-0003BA3F9857

Breast Cancer Adverse Event NCT00382070 - rade 2 and 3 Adverse Event Report Breast Cancer NCT00382070 NSABP B-42

- 20/09/21 - 1 Formulaire, 2 Groupes Item, 9 Eléments de données, 1 Langue
Groupes Item: Header, Adverse event
NSABP Protocol B-42 - Grade 2 and 3 Adverse Event (AE) Report Form Worksheet Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer NCT00382070 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=17ADF05F-DB75-341D-E044-0003BA3F9857

dbGaP phs000851 African American Breast Cancer GWAS - Eligibility

- 29/01/25 - 5 Formulaires, 1 Groupe Item, 1 Élément de données, 1 Langue
Groupe Item: IG.elig
Principal Investigator: Chris Haiman, ScD, University of Southern California, CA, USA MeSH: Breast Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000851 The GWAS includes African American participants from 9 epidemiological studies of breast cancer, comprising a total of 3,153 cases and 2,831 controls (cases/controls: The Multiethnic Cohort Study (MEC), 734/1,003; The Los Angeles component of The Women's Contraceptive and Reproductive Experiences (CARE) Study, 380/224; The Women's Circle of Health Study (WCHS), 272/240; The San Francisco Bay Area Breast Cancer Study (SFBCS), 172/231; The Northern California Breast Cancer Family Registry (NC-BCFR), 440/53;The Carolina Breast Cancer Study (CBCS), 656/608; The Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) Cohort, 64/133; The Nashville Breast Health Study (NBHS), 310/186; and, The Wake Forest University Breast Cancer Study (WFBC), 125/153). Quality control of the GWAS data and additional details can be found in Chen et al. Hum Genet. 2013 (PMID: 22923054)

pht004682.v1.p1

1 Groupe Item 2 Eléments de données

pht004683.v1.p1

1 Groupe Item 5 Eléments de données

pht004684.v1.p1

1 Groupe Item 7 Eléments de données

pht004685.v1.p1

1 Groupe Item 4 Eléments de données

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

- 27/11/24 - 5 Formulaires, 1 Groupe Item, 1 Élément de données, 1 Langue
Groupe Item: 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 Groupe Item 5 Eléments de données

pht004835.v1.p1

1 Groupe Item 5 Eléments de données

pht004836.v1.p1

1 Groupe Item 16 Eléments de données

pht004837.v1.p1

1 Groupe Item 5 Eléments de données

dbGaP phs000912 San Francisco Bay Area Latina Breast Cancer Study - pht004733.v1.p1

- 11/04/24 - 5 Formulaires, 1 Groupe Item, 7 Eléments de données, 1 Langue
Groupe Item: pht004733
Principal Investigator: Elad Ziv, MD, University of California, San Francisco, USA MeSH: Breast Neoplasms,Receptors, Estrogen,Receptors, Progesterone https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000912 The genome-wide association study (GWAS) includes participants enrolled into two different studies. The first study, the San Francisco Bay Area Cancer Study (SFBCS) is a population-based case-control study of breast cancer conducted in the San Francisco Bay Area and included women ages 35-79 years from three racial/ethnic groups: Non-Hispanic whites, African Americans, and Hispanics/Latinas. For the GWAS, only Hispanic/Latina women were included. Women diagnosed with invasive breast cancer between 1995 and 2002 were identified through the Greater Bay Area Cancer Registry. Controls were identified by random digit dialing and were frequency-matched to cases by age in 5 year increments and by race/ethnicity. Hispanic/Latina ethnicity was assessed by self-report. 175 Hispanic/Latina cases and 307 Hispanic/Latina controls from the SFBCS had given adequate consent and provided biospecimens that were used in the GWAS to be included in this data submission. The second study is the Northern California site of the Breast Cancer Family Registry (NC-BCFR). This population-based family study recruited breast cancer cases ages 18-64 years diagnosed from 1995-2009 that were identified through the Greater Bay Area Cancer Registry. Cases included all women at increased genetic susceptibility for breast cancer who met one or more of the following criteria: (a) being diagnosed with breast cancer at age 35 years; b) having a personal history of ovarian cancer or childhood cancer; (c) being diagnosed with two different breast cancers (bilateral breast cancers), with the first one diagnosed at age 50 years; and d) having one or more first-degree relatives with breast cancer, ovarian cancer or childhood cancer. Cases not meeting these criteria were randomly sampled and racial/ethnic minorities were oversampled. Controls were recruited by random digit dialing and were matched by 5-year age increments and by race/ethnicity. For the current GWAS only Latina/Hispanic cases and controls were included. Latina/Hispanic ethnicity was assessed by self-report. 631 Hispanic/Latina cases and 61 Hispanic/Latina controls from the NC-BCFR had given adequate consent and provided biospecimens that were used in the GWAS to be included in this data submission.

Eligibility

1 Groupe Item 4 Eléments de données

pht004731.v1.p1

1 Groupe Item 3 Eléments de données

pht004732.v1.p1

1 Groupe Item 10 Eléments de données

pht004730.v1.p1

1 Groupe Item 3 Eléments de données

dbGaP phs000975 Nurses' Health Study (NHS) - Eligibility

- 22/01/24 - 5 Formulaires, 1 Groupe Item, 1 Élément de données, 1 Langue
Groupe Item: IG.elig
Principal Investigator: Rulla Tamimi, ScD, Brigham and Women's Hospital, Boston, MA, USA MeSH: Mammographic density,Breast Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000975 The Nurses' Health Study is an on-going prospective cohort study of women that was initiated in 1976. This specific study was part of a larger study to advance our knowledge of breast cancer etiology, expand the current knowledge of mammographic density, and clarify the relationship between mammographic density and breast cancer risk. We conducted a nested case control study of breast cancer among women who provided a blood sample. We then targeted our mammogram collection to participants that were selected as part of this nested case-control study (i.e. those who had provided a blood sample). The mammogram closest to the date of blood draw (~1989-1990) was used. We assessed mammographic breast density from digitized film images using a computer assisted thresholding method (Cumulus). The women in this study were genotyped using the Illumina Omni Express Platform.

pht004933.v1.p1

1 Groupe Item 3 Eléments de données

pht004934.v1.p1

1 Groupe Item 3 Eléments de données

pht004935.v1.p1

1 Groupe Item 16 Eléments de données

pht004936.v1.p1

1 Groupe Item 4 Eléments de données

dbGaP phs000826 Prediction of Trastuzumab Benefit in Adjuvant Breast Cancer: NSABP B31 - pht004336.v1.p1

- 16/01/24 - 5 Formulaires, 1 Groupe Item, 8 Eléments de données, 1 Langue
Groupe Item: pht004336
Principal Investigator: Soonmyung Paik, National Surgical Adjuvant Breast and Bowel Project, Pittsburgh PA, USA MeSH: Breast Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000826 **Background** National Surgical Adjuvant Breast and Bowel Project (NSABP) trial B-31 suggested the efficacy of adjuvant trastuzumab, even in HER2-negative breast cancer. This finding prompted us to develop a predictive model for degree of benefit from trastuzumab using archived tumor blocks from B-31. **Methods** Case subjects with tumor blocks were randomly divided into discovery (n = 588) and confirmation cohorts (n = 991). A predictive model was built from the discovery cohort through gene expression profiling of 462 genes with nCounter assay. A predefined cut point for the predictive model was tested in the confirmation cohort. Gene-by-treatment interaction was tested with Cox models, and correlations between variables were assessed with Spearman correlation. Principal component analysis was performed on the final set of selected genes. All statistical tests were two-sided. **Results** Eight predictive genes associated with HER2 (ERBB2, c17orf37, GRB7) or ER (ESR1, NAT1, GATA3, CA12, IGF1R) were selected for model building. Three-dimensional subset treatment effect pattern plot using two principal components of these genes was used to identify a subset with no benefit from trastuzumab, characterized by intermediate-level ERBB2 and high-level ESR1 mRNA expression. In the confirmation set, the predefined cut points for this model classified patients into three subsets with differential benefit from trastuzumab with hazard ratios of 1.58 (95% confidence interval [CI] = 0.67 to 3.69; P = .29; n = 100), 0.60 (95% CI = 0.41 to 0.89; P = .01; n = 449), and 0.28 (95% CI = 0.20 to 0.41; P .001; n = 442; P interaction between the model and trastuzumab .001). **Conclusions** We developed a gene expression-based predictive model for degree of benefit from trastuzumab and demostrated that HER2-negative tumors belong to the moderate benefit group, thus providing justification for testing trastuzumab in HER2-negative patients (NSABP B-47). ** Reprinted from J Natl Cancer Inst;2013;105:1782-1788 with permission from Oxford University Press.

pht004334.v1.p1

1 Groupe Item 4 Eléments de données

pht004335.v1.p1

1 Groupe Item 5 Eléments de données

pht004337.v1.p1

1 Groupe Item 8 Eléments de données

Eligibility

1 Groupe Item 44 Eléments de données

dbGaP phs001017 Breast Cancer Susceptibility - Eligibility

- 08/10/23 - 5 Formulaires, 1 Groupe Item, 1 Élément de données, 1 Langue
Groupe Item: IG.elig
Principal Investigator: Richard K. Wilson, PhD, The Genome Institute, Washington University School of Medicine, St. Louis, MO, USA MeSH: Breast Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001017 Genetic factors account for a large fraction of breast cancer risk and it is estimated that up to 30% of breast cancers have a heritable component. Inherited cancer susceptibility is associated with early-onset of malignancies in general. Although 20% of young women with breast cancer have germline mutations in the best understood breast cancer susceptibility genes, BRCA1, BRCA2 and TP53, in the remaining 80% of women with early-onset breast cancer, the genetic factors contributing to disease remain unexplained. By studying the extreme phenotype of women diagnosed at an early age there is enrichment for genetic factors that contribute to breast cancer. This study contains the whole exome sequence of 384 women diagnosed with invasive breast cancer prior to 40 years of age. Each of the subjects reported a family history of breast cancer and lacked mutations in BRCA1 and BRCA2.

pht005074.v1.p1

1 Groupe Item 3 Eléments de données

pht005076.v1.p1

1 Groupe Item 3 Eléments de données

pht005077.v1.p1

1 Groupe Item 5 Eléments de données

pht005075.v1.p1

1 Groupe Item 3 Eléments de données

dbGaP phs001043 GWAS of Breast Events with Adjuvant Aromatase Inhibitors - pht005313.v1.p1

- 07/08/23 - 5 Formulaires, 1 Groupe Item, 2 Eléments de données, 1 Langue
Groupe Item: pht005313
Principal Investigator: James N. Ingle, M.D., Mayo Clinic, Rochester, MN, USA MeSH: Neoplasm,Breast Neoplasms,Neoplasm Metastasis https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001043 *Source of patients*:The source of the patients for this genome-wide case-control study was MA.27, which was conducted as a multi-cooperative group effort under the auspices of the NCI Breast Cancer Intergroup of North America. The NCIC Clinical Trials Group (CTG) serves as the coordinating group, with participation by the NCI-sponsored North Central Cancer Treatment Group, Eastern Cooperative Oncology Group (ECOG), Southwest Oncology Group, and Cancer and Leukemia Group B (CALGB). MA.27 involved postmenopausal women with histologically confirmed and completely resected invasive breast cancer with surgical margins clear of invasive carcinoma in the following TMN categories (AJCC Version 6): pT1, pT2, pT3; pNx, pN0, pN1, pN2, pN3 (only when the sole basis is presence of 10 or more involved axillary nodes); MO. The primary tumor must have been estrogen receptor (ER) and/or progesterone receptor positive. Patients were stratified by lymph node status at diagnosis, prior adjuvant chemotherapy, and trastuzumab use and were randomized to 5 years of adjuvant therapy with anastrozole or exemestane. The trial was activated on May 26, 2003, and reached its accrual objectives on July 31, 2008, after the randomization of 6827 North American patients, with the majority (79%) providing DNA and consent for genetic testing. Non-North American patients were also entered by the International Breast Cancer Study Group but they did not contribute DNA. From 2003 to December 21, 2004, patients also underwent a second randomization to celecoxib 400 mg twice daily or placebo but, after the entry of 1,622 patients, this treatment was discontinued because of reports of increased cardiovascular risk associated with celecoxib. The final results of this study have been published, see Goss et al., 2013 (23358971). The patients in this analysis came from three cohorts: Cohort 1 consisted of 870 patients genotyped on the Illumina Human610-Quad BeadChip studied in a GWAS with the phenotype of musculoskeletal adverse event, see Ingle et al., 2010 (20876420), Cohort 2 consisted of 882 patients genotyped on the Illumina OmniExpress platform studied in a GWAS with the phenotype of fragility fractures, see Liu et al., 2014 (25148458), and the remaining 2913 patients were genotyped with the Illumina OmniExpressExome platform.

pht005314.v1.p1

1 Groupe Item 3 Eléments de données

pht005315.v1.p1

1 Groupe Item 28 Eléments de données

pht005316.v1.p1

1 Groupe Item 6 Eléments de données

Eligibility

1 Groupe Item 3 Eléments de données

dbGaP phs001028 Complete Genomics Deep Whole-Genome Sequencing of Circulating Tumor Cells - pht005128.v1.p1

- 29/07/23 - 4 Formulaires, 1 Groupe Item, 3 Eléments de données, 1 Langue
Groupe Item: pht005128
Principal Investigator: Brock A. Peters, PhD, Complete Genomics, Inc. Mountain View, CA, USA MeSH: Breast Neoplasms,Neoplasm Metastasis,Carcinoma, Lobular https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001028 Circulating tumor cells (CTCs) are considered to be informative non-invasive biopsy for the early detection, diagnosis or therapy guidance of cancer. CTCs also contain most of the heterogeneity found across multiple metastatic sites. In this study, we combine recently improved CTC isolation methods, resulting in almost pure CTCs, with advanced whole genome sequencing (WGS) based on Long Fragment Read (LFR) technology to demonstrate, for the first time, the research and clinical utility of an accurate, comprehensive, phased, and quantitative genomic analysis of CTCs. In particular, genomes of 34 CTCs, collected at two different time points from a patient whose metastatic breast cancer ultimately became resistant to standard treatments, were analyzed as 3072 barcoded sub-genomic compartments of long DNA. An average read coverage of 23X per cell enabled the high-resolution detection of somatic variants, cancer copy number variations (CNVs) and structural variants, including 133 CNVs shorter than 1Mb and an early chromothripsis-like event.

pht005129.v1.p1

1 Groupe Item 3 Eléments de données

pht005130.v1.p1

1 Groupe Item 3 Eléments de données

pht005131.v1.p1

1 Groupe Item 7 Eléments de données

dbGaP phs001044 Breast Cancer Risk Pathways - Eligibility

- 29/07/23 - 5 Formulaires, 1 Groupe Item, 1 Élément de données, 1 Langue
Groupe Item: IG.elig
Principal Investigator: Andrea H. Bild, PhD, University of Utah, Salt Lake City, UT, USA MeSH: Breast Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001044 We sought to identify genomic variants that differed between individuals who developed familial breast cancer and individuals who had a family history of breast cancer but who had not developed breast cancer. We aggregated these data at the pathway level to identify pathways that play a role in familial breast cancer development. We profiled peripheral blood cells, extracted DNA, and sequenced the DNA using exome-capture sequencing to identify genomic variants in these samples. For 34 of the 35 samples, we also profiled peripheral blood using Affymetrix Human Exon 1.0 ST Array microarrays. Those data can be found in Gene Expression Omnibus under accession identifier GSE47862.

pht005272.v1.p1

1 Groupe Item 3 Eléments de données

pht005274.v1.p1

1 Groupe Item 5 Eléments de données

pht005273.v1.p1

1 Groupe Item 3 Eléments de données

pht005275.v1.p1

1 Groupe Item 5 Eléments de données

dbGaP phs001050 Breast Cancer Genome Guided Therapy Study (BEAUTY) - Eligibility

- 23/06/23 - 5 Formulaires, 1 Groupe Item, 1 Élément de données, 1 Langue
Groupe Item: IG.elig
Principal Investigator: Matthew Goetz, MD, Mayo Clinic, Rochester, MN, USA MeSH: Breast Neoplasms,Carcinoma, Ductal, Breast https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001050 The Breast Cancer Genome Guided Therapy Study (BEAUTY) is a prospective neoadjuvant clinical study enrolling 140 women with Stage I-III breast cancer. The goals of this study were to 1) perform comprehensive sequencing of germline and tumor tissues (exome and RNA seq), 2) identify genomic alterations and perturbed pathways associated with response/resistance to standard chemotherapy, and 3) develop patient-derived xenograft (PDX) for testing of therapeutic regimens chosen on the basis of alterations identified by genetic sequencing.

pht005231.v1.p1

1 Groupe Item 3 Eléments de données

pht005233.v1.p1

1 Groupe Item 12 Eléments de données

pht005234.v1.p1

1 Groupe Item 13 Eléments de données

pht005232.v1.p1

1 Groupe Item 5 Eléments de données

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