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dbGaP phs000941 Phylogenetic Analyses Reveal Complex Patterns of Melanoma Metastasis - pht004901.v1.p1

- 30/01/24 - 3 moduli, 1 ItemGroup, 3 elementi, 1 linguaggio
ItemGroup: pht004901
Principal Investigator: MeSH: Melanoma,Neoplasm Metastasis,Phylogeny https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000941 Subpopulations of cells in a primary melanoma can disseminate and establish metastases. Still, the precise ancestral relationship between primary tumors and their metastases is not well understood. Using whole-exome sequencing (for discovery) and targeted sequencing (for validation), we analyzed mutation patterns of primary melanomas and two or more metastases in each of 8 patients to determine their phylogenetic relationships, profiling a total of 31 total tumors. The resulting data show that in 6 of 8 cases, genetically unique cell populations in the primary metastasized in parallel to distinct anatomic sites, rather than sequentially. These data also indicate that individual metastases were sometimes founded by multiple cell populations of the primary that were genetically distinct.

pht004902.v1.p1

1 ItemGroup 3 elementi

pht004903.v1.p1

1 ItemGroup 5 elementi

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

- 07/08/23 - 5 moduli, 1 ItemGroup, 2 elementi, 1 linguaggio
ItemGroup: 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 ItemGroup 3 elementi

pht005315.v1.p1

1 ItemGroup 28 elementi

pht005316.v1.p1

1 ItemGroup 6 elementi

Eligibility

1 ItemGroup 3 elementi

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

- 29/07/23 - 4 moduli, 1 ItemGroup, 3 elementi, 1 linguaggio
ItemGroup: 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 ItemGroup 3 elementi

pht005130.v1.p1

1 ItemGroup 3 elementi

pht005131.v1.p1

1 ItemGroup 7 elementi

dbGaP phs001063 Genomic Characterization of PDX Models for Breast Cancer Brain Metastases - pht005289.v1.p1

- 23/06/23 - 5 moduli, 1 ItemGroup, 2 elementi, 1 linguaggio
ItemGroup: pht005289
Principal Investigator: Jean J. Zhao, PhD, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA MeSH: Breast Neoplasms,Neoplasm Metastasis,Brain Neoplasms,Neoplasm Transplantation,Molecular Targeted Therapy https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001063 We have developed orthotopic patient-derived xenograft models of HER2 positive breast cancer metastasized into the brain of patients to test novel therapeutic strategies. In this study, we identified a novel combinatorial therapeutic strategy that has resulted in a durable remission and markedly increased overall survival in majority of patient-derived xenograft (PDX) models tested. We performed whole exome sequencing analysis of these PDX tumors and their matched blood and patient samples to investigate drug sensitive and resistance mechanisms. Our sequencing data revealed an interesting association of genotyping and phenotyping with tumors responses to drug treatment.

pht005290.v1.p1

1 ItemGroup 3 elementi

pht005291.v1.p1

1 ItemGroup 3 elementi

pht005292.v1.p1

1 ItemGroup 12 elementi

Eligibility

1 ItemGroup 1 elemento

dbGaP phs001087 Clonal Evolution of Platinum-Resistant Metastatic Urothelial Cancer - pht005759.v3.p1

- 22/06/23 - 5 moduli, 1 ItemGroup, 2 elementi, 1 linguaggio
ItemGroup: pht005759
Principal Investigator: Bishoy Faltas, MD, Weill-Cornell Medicine, New York, NY, USA MeSH: Carcinoma, Transitional Cell,Urinary Bladder Neoplasms,Neoplasm Metastasis https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001087 Using whole-exome sequencing of urothelial carcinoma samples including matched sets of primary and locally recurrent or metastatic UC tumors collected over time and space and whole-exome sequencing of germline DNA samples, we provide the first detailed analysis of deleterious germline variants of urothelial carcinoma. We performed a systematic and integrated analyses to examine germline-somatic variant interactions that revealed insights into their biological role in urothelial cancer.

pht005760.v3.p1

1 ItemGroup 7 elementi

pht005761.v3.p1

1 ItemGroup 8 elementi

Eligibility

1 ItemGroup 2 elementi

pht005758.v3.p1

1 ItemGroup 3 elementi

dbGaP phs001127 Genomic Analysis of Paired Endometrial Cancer Primaries and Metastases - Eligibility

- 19/06/23 - 5 moduli, 1 ItemGroup, 1 elemento, 1 linguaggio
ItemGroup: IG.elig
Principal Investigator: Rameen Beroukhim, MD, PhD, Dana-Farber Cancer Institute, Boston, MA, USA, Brigham and Women's Hospital, Boston, MA, USA, Broad Institute of MIT and Harvard, Cambridge, MA, USA MeSH: Endometrial Neoplasms,Neoplasm Metastasis https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001127 Formation of metastases is the major cause of cancer related deaths. Recent studies have sequenced primary endometrial carcinomas yielding data for a single entity in the progression from the birth of a progenitor tumor cell to metastatic disease. However, the progression of these tumors to metastases has not been characterized. We performed whole-exome sequencing of 98 tumor biopsies including complex atypical hyperplasias, primary tumors and paired abdominopelvic metastases to survey the evolutionary landscape of endometrial cancer. We expanded and reanalyzed TCGA-data, identifying novel recurrent alterations in primary tumors, including mutations in the estrogen receptor cofactor *NRIP1* in 12% of patients. We found that likely driver events tended to be shared by primary and metastatic tissue-samples, with notable exceptions such as *ARID1A* mutations. Phylogenetic analyses in cases with multiple metastases indicated these metastases typically arose from one lineage of the primary tumor. These data indicate extensive genetic heterogeneity within endometrial cancers and relative homogeneity across metastatic sites.

pht005525.v1.p1

1 ItemGroup 2 elementi

pht005526.v1.p1

1 ItemGroup 3 elementi

pht005527.v1.p1

1 ItemGroup 7 elementi

pht005528.v1.p1

1 ItemGroup 5 elementi

Lung Cancer NCT00096265 Quality of Life - PQ RTOG Phase III Multiple Brain Metastases Fact Subscale - 2277326v3.0 - PQ RTOG Phase III Multiple Brain Metastases Fact Subscale

- 27/09/21 - 1 modulo, 3 itemgroups, 43 elementi, 1 linguaggio
Itemgroups: Header, Physical Well-Being, Additional Concerns
PQ RTOG Phase III Multiple Brain Metastases Fact Subscale Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D7FA7BFE-292F-6626-E034-0003BA12F5E7

Eligibility DRKS00007744 NCT01026142 Breast Cancer - Eligibility

- 27/09/21 - 1 modulo, 2 itemgroups, 17 elementi, 2 lingue
Itemgroups: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT01026142

Eligibility Metastatic Breast Cancer NCT01288092

- 20/09/21 - 1 modulo, 2 itemgroups, 18 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01288092

Eligibility Metastatic Breast Cancer NCT00907959

- 20/09/21 - 1 modulo, 2 itemgroups, 18 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00907959

Eligibility Neoplasm Metastasis NCT00327652

- 20/09/21 - 1 modulo, 1 ItemGroup, 15 elementi, 1 linguaggio
ItemGroup: Criteria
Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT00327652

Cognitive/Functional Effects NCT01372774 Eligibility - N107C Pre-Registration (Step 1) Form and Eligibility Checklist - 3226376v1.0 - N107C Pre-Registration (Step 1) Form and Eligibility Checklist

- 20/09/21 - 1 modulo, 4 itemgroups, 45 elementi, 1 linguaggio
Itemgroups: Pre-Registration Inclusion Criteria - All responses in this section below must be "Yes.", Pre-Registration Exclusion Criteria, Registration Check, Randomization Check (continued) - All responses in section below may be "Yes" or "No."
N107C Pre-Registration (Step 1) Form and Eligibility Checklist Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases That Have Been Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A06D80B4-4143-B9BC-E040-BB89AD437EB8

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