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

- 19-06-23 - 5 Formulieren, 1 Itemgroep, 1 Data-element, 1 Taal
Itemgroep: 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 Itemgroep 2 Data-elementen

pht005526.v1.p1

1 Itemgroep 3 Data-elementen

pht005527.v1.p1

1 Itemgroep 7 Data-elementen

pht005528.v1.p1

1 Itemgroep 5 Data-elementen

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

- 07-08-23 - 5 Formulieren, 1 Itemgroep, 2 Data-elementen, 1 Taal
Itemgroep: 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 Itemgroep 3 Data-elementen

pht005315.v1.p1

1 Itemgroep 28 Data-elementen

pht005316.v1.p1

1 Itemgroep 6 Data-elementen

Eligibility

1 Itemgroep 3 Data-elementen

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 Formulier, 3 Itemgroepen, 43 Data-elementen, 1 Taal
Itemgroepen: 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 DRKS00009676 NCT00321620 Bone Metastases - Eligibility

- 20-09-21 - 1 Formulier, 2 Itemgroepen, 10 Data-elementen, 2 Talen
Itemgroepen: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00321620

Lung Cancer NCT00096265 Treatment - TF RTOG Phase III - Multiple Brain Mets Treatment Summary Form - 2277910v3.0 - TF RTOG Phase III - Multiple Brain Mets Treatment Summary Form

- 09-01-15 - 1 Formulier, 1 Itemgroep, 74 Data-elementen, 1 Taal
Itemgroep: Header
TF RTOG Phase III - Multiple Brain Mets Treatment Summary Form 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=D81D1978-6B15-04EC-E034-0003BA12F5E7

Lung Cancer NCT00096265 On-Study - I1 RTOG Phase III - Multiple Brain Mets Initial Evaluation Form - 2277804v3.0 - I1 RTOG Phase III - Multiple Brain Mets Initial Evaluation Form

- 09-01-15 - 1 Formulier, 5 Itemgroepen, 29 Data-elementen, 1 Taal
Itemgroepen: Header, Module 1, Patient Characteristics, Size of Lesion(s), Module 4
I1 RTOG Phase III - Multiple Brain Mets Initial Evaluation Form 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=D81B6746-376F-61E1-E034-0003BA12F5E7

Metastatic Cancer NCT00134056 Treatment - SOUTHWEST ONCOLOGY GROUP S0421 PAIN MEDICATION LOG: Step 1 Randomization Form - 2305593v3.0 - SOUTHWEST ONCOLOGY GROUP S0421 PAIN MEDICATION LOG: Step 1 Randomization Form

- 13-04-21 - 1 Formulier, 3 Itemgroepen, 16 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Patient Instructions, Medication
SOUTHWEST ONCOLOGY GROUP S0421 PAIN MEDICATION LOG: Step 1 Randomization Form Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F15B6C7A-5A30-3964-E034-0003BA3F9857

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

- 29-07-23 - 4 Formulieren, 1 Itemgroep, 3 Data-elementen, 1 Taal
Itemgroep: 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 Itemgroep 3 Data-elementen

pht005130.v1.p1

1 Itemgroep 3 Data-elementen

pht005131.v1.p1

1 Itemgroep 7 Data-elementen

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Local Laboratories

- 13-08-20 - 1 Formulier, 3 Itemgroepen, 7 Data-elementen, 1 Taal
Itemgroepen: Date of visit, Assessment Date, Laboratory, Local, Laboratory, Local
Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Log

- 26-04-21 - 1 Formulier, 9 Itemgroepen, 117 Data-elementen, 1 Taal
Itemgroepen: Date of visit, Assessment Date, Event Log, Status, Non-serious Adverse Event, Serious Adverse Event, Concomitant Agent, Concomitant Agent, Adrenal Cortex Hormones, Blood product; Supportive care, Collection of blood specimen for laboratory procedure, Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Informed Consent, Withdraw (activity)
Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Cycle 1 - Day 15

- 13-10-20 - 1 Formulier, 11 Itemgroepen, 157 Data-elementen, 1 Taal
Itemgroepen: Date of visit, Assessment Date, Laboratory Procedures, Central Laboratory; Laboratory Procedures, Local, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Central Laboratory, Data, Disease, Operative Surgical Procedures, Vital signs, Experimental drug, Topotecan, Dosage, Therapeutic procedure, Confirmation, Lapatinib, Compliance behavior, Continuation status, Study
Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Day 1 Predose

- 13-10-20 - 1 Formulier, 6 Itemgroepen, 40 Data-elementen, 1 Taal
Itemgroepen: Date of visit, Assessment Date, Neurologic Examination, Neurologic Symptoms, Associated with, Neoplasms, Vital signs, Randomization, Numbers, Therapeutic regimen
Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

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