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CHEST X-RAY (AP AND LATERAL) Roche H0650g Breast Cancer - CHEST X-RAY (AP AND LATERAL)

- 5/16/17 - 1 form, 1 itemgroup, 5 items, 1 language
Itemgroup: Chest X-Ray
Study part: Chest X- ray. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

STUDY TERMINATION CHEST X-RAY (AP AND LATERAL) Roche H0650g Breast Cancer - STUDY TERMINATION CHEST X-RAY (AP AND LATERAL)

- 5/20/17 - 1 form, 1 itemgroup, 5 items, 1 language
Itemgroup: Chest X-Ray
Study part: Study Termination Chest X- ray. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

Eligibility Breast Cancer NCT01052740

- 11/3/17 - 1 form, 2 itemgroups, 18 items, 1 language
Itemgroups: Criteria, Exclusion Criteria
X-Ray Mammography Standard of Care Protocol; ODM derived from: https://clinicaltrials.gov/show/NCT01052740

Eligibility Breast Cancer NCT02426489

- 4/29/16 - 1 form, 2 itemgroups, 15 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Improving Diagnosis of Breast Cancer by Using a Combined MRI and Positron Emission Mammography (MRI-PEM) System; ODM derived from: https://clinicaltrials.gov/show/NCT02426489

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

- 4/11/24 - 5 forms, 1 itemgroup, 7 items, 1 language
Itemgroup: 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 itemgroup 4 items

pht004731.v1.p1

1 itemgroup 3 items

pht004732.v1.p1

1 itemgroup 10 items

pht004730.v1.p1

1 itemgroup 3 items

Eligibility Estrogen Receptor-positive Breast Cancer NCT01409811

- 2/28/16 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Biomarkers in Tissue Samples From Patients With Newly Diagnosed Breast Cancer Treated With Zoledronic Acid; ODM derived from: https://clinicaltrials.gov/show/NCT01409811

Eligibility Breast Cancer NCT02244593

- 10/8/19 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
FAST MRI Study in Breast Cancer Survivors; ODM derived from: https://clinicaltrials.gov/show/NCT02244593

dbGaP phs000395 CPMCRI Breast Health Cohort - Eligibility

- 10/12/22 - 5 forms, 1 itemgroup, 2 items, 1 language
Itemgroup: IG.elig
Principal Investigator: Elad Ziv, MD, University of California, San Francisco, CA, USA MeSH: Breast Neoplasm,Mammography https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000395 *Description of Cohort*: The California Pacific Medical Center (CPMC) Breast Health Cohort is a cohort study based at CPMC and is linked to the San Francisco Mammography Registry, one of the sites of the NCI-funded Breast Cancer Screening Consortium (U01CA063740). CPMC is a community hospital in San Francisco, which has one of the highest volumes for mammography in San Francisco. Between September 2004 and June 2007, 90,000 mammograms were performed at CPMC. The CPMC breast health cohort collects demographic and risk factor data on women receiving mammography through participation in the San Francisco Mammography Registry, as part of the Breast Cancer Screening Consortium (U01CA063740). The SFMR database collects information from all sources, including a questionnaire on demographic and risk factor information, the clinical results of the breast examination, the measures of breast density by Dr. John Shepherd and the women who agreed to donate a blood sample. By merging these various sources of information we have very efficiently developed a large sample of women who have donated blood and have had a measure of mamographic density. *Blood Collection*: Dr. Steve Cummings is leading an effort to collect and archive blood samples from women who are receiving mammography screening. All women who are sent for a screening mammogram at CPMC are considered eligible. Since the cohort began collecting blood samples in July 2004 until June 2007, samples have been collected from over 11,000 women. *Measurement of Breast Density*: Dr. John Shepherd is currently measuring breast density in a large fraction of the cohort using an automated approach with single X-ray absorptiometry. Dr. Shepherd has established a link with the CPMC mammography center that allows him to collect routine digital mammography information. Using the data from the mammogram, Dr. Shepherd and his group have developed the single X-ray absorptiometry (SXA) technique for measuring density which is described in more detail below. The table demonstrates the distribution of demographic variables and some breast cancer risk factors of women who donated blood and had a breast density measurement in the CPMC breast health cohort. Nearly 80% of the participants are Caucasian and most of the women are post-menopausal with a median age of ~52. Since it will be difficult to accrue a large enough sample from each ethnic group, our study will focus only on Caucasian women. *Table*: Demographic variables, reproductive history and family history of breast cancer among 2962 women participating in the CPMC cohort study who contributed blood samples between 1994-1997. table border="1" tr thVariable/th thMedian/Percentage/th /tr tr tdAge (Median/IQR)/td td align="center"52 (46-59)/td /tr tr tdEthnicity/td td/td /tr tr td align="right"Caucasian/White/td td align="center"0.76/td /tr tr td align="right"Asian/Pacific Islander/td td align="center"0.141/td /tr tr td align="right"Hispanic/td td align="center"0.029/td /tr tr td align="right"Mixed Race/Ethnicity/td td align="center"0.039/td /tr tr td align="right"African American/Black/td td align="center"0.022/td /tr tr td align="right"American Indian/td td align="center"0.001/td /tr tr td align="right"Other/td td align="center"0.009/td /tr tr tdFirst degree relative with breast cancer/td td align="center"0.17/td /tr tr tdAge at first birth/td td/td /tr tr tdNulliparous/td td align="center"0.39/td /tr tr td align="right"Age20/td td align="center"0.043/td /tr tr td align="right"Age40/td td align="center"0.032/td /tr tr td align="right"Age30, ≥20/td td align="center"0.251/td /tr tr td align="right"Age30, ≤40/td td align="center"0.282/td /tr /table *Measurement of Breast Density in Cohort*: Measurement of breast density is accomplished using an automated technique for all mammograms obtained by Dr. Shepherd using Single X-Ray absorptiometry (SXA). SXA measurement of breast density is done on approximately 30% of all screening mammograms. Below we describe the method for measurement of breast density by SXA by Dr. Shepherd's group and its validation and association with breast cancer. As we demonstrate below, breast density, as measured by SXA, is an automated, highly reproducible measure of the density of breast tissue and is associated with breast cancer risk. *SXA for Quantifying Breast Density*: Single x-ray absorptiometry (SXA) was initially developed for measuring bone density. SXA can determine the fraction of each of two densities simultaneously using the fact the sample is a constant thickness, the thickness in known, and the total attenuation is known. In applying this technique to breast density, we assume a two compartment model: fat and non-fatty (fibroglandular tissue). We use a reference material composed of various concentrations of two materials: one which is the same density as fat and another which is the same density as fibroglandular tissue. The reference material (phantom) is placed in the X-ray field with each mammogram. We have been able to implement this in a way that is unintrusive to the patient and technologist at CPMC. Assuming this two-compartment model and a constant known breast thickness, we can then calculate the percent density at any region of the breast based on the assumption that % pixel grey-scale is proportion to the mass fractions of breast fat and lean tissue. If reference materials (a phantom) of fat and fibroglandular tissue are imaged with the patient's breast and the reference materials have the same thickness as the patient's breast, then the breast's grey-scale values can be converted to fat/fibroglandular mass fractions by interpolating between those two references. The total percent density is found by averaging the volume fraction over all breast pixels. The phantom being used for breast density assessment at CPMC began to be used in September 2004. The phantom does not have to be manipulated by the technologist and stays attached on the mammography device during standard craniocaudal (CC) views. Thus it creates minimal to no interference with the clinical mammogram. *Reproducibility of breast density measures*: Traditional measures of mammographic density require some human interpretation. A human reader outlines the area perceived to be dense and a computer then calculates the percent area outlined as a percent of the entire image. Thus, while traditional mammographic density is associated with breast cancer risk, it has some limitations. In a study by Drs. Shepherd, Kerlikowske, et al., the correlation coefficient (Pearson's R) between different readers was 0.8-0.9. In contrast to the traditional mammographic density measurement, the SXA measurement is fully automated and, therefore, the reproducibility of the measurement is higher. Dr. Shepherd and colleagues have performed a replication study of SXA as a measurement of breast density. They have estimated the correlation coefficient of the SXA measurement of breast density to be 0.98. Thus, as expected for an automated measure, SXA is a highly reproducible measure of mammographic breast density. Drs. Shepherd and Kerlikowske have recently analyzed the association between breast cancer risk and breast density as measured by SXA (Shepherd et al., Cancer Epi Biomarkers and Prev, 2011, PMID: 21610220). They found that women in the highest quintile of % volumetric density had an odds ratio of 4.1 (95% CI: 2.3 - 7.2) for breast cancer risk compared to women in the lowest quintile of volumetric density. Thus volumetric density appears to be a highly reproducible, automated measure of breast cancer.

pht002362.v1.p1

1 itemgroup 5 items

pht002363.v1.p1

1 itemgroup 16 items

pht002364.v1.p1

1 itemgroup 5 items

pht002361.v1.p1

1 itemgroup 4 items

Eligibility Breast Cancer NCT01067976

- 9/27/21 - 1 form, 2 itemgroups, 16 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI; ODM derived from: https://clinicaltrials.gov/show/NCT01067976

dbGaP phs001250 Sequencing of Coding and Non-coding Regions in Primary Breast Cancers and Patient-matched Controls - pht006326.v1.p1

- 3/20/23 - 4 forms, 1 itemgroup, 3 items, 1 language
Itemgroup: pht006326
Principal Investigator: Todd R. Golub, MD, Harvard Medical School; Pediatric Oncology, Dana-Farber Cancer Institute; Broad Institute of MIT and Harvard, Cambridge, MA, USA MeSH: Breast Neoplasms,Sequence Analysis, DNA,Hepatocyte Nuclear Factor 3-alpha https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001250 Genomic analysis of tumor samples has led to the identification of hundreds of cancer genes based on the presence of mutations in protein-coding regions. By contrast, much less is known about cancer-causing mutations in non-coding regions. Here, we performed deep sequencing in 360 primary breast cancers and developed computational methods to identify significantly mutated promoters. Clear signals were found in the promoters of four genes. FOXA1, a known driver of hormone-receptor positive breast cancer, harbors a mutational hotspot in its promoter that leads to overexpression through increased E2F binding. RMRP and NEAT1, two non-coding RNA genes, carry mutations that alter protein binding to the promoter and impact expression levels. Overall, our study shows that recurrent mutations in or near gene promoters in cancers have functional consequences. Power analyses indicate that more such genes remain to be discovered through deep sequencing of adequately sized patient cohorts.

pht006325.v1.p1

1 itemgroup 2 items

pht006327.v1.p1

1 itemgroup 8 items

pht006328.v1.p1

1 itemgroup 4 items

Eligibility Breast Neoplasms NCT02449824

- 2/15/19 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
MRI and Early Decision-making in Chemotherapy for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02449824

Eligibility Breast Cancer NCT00656604

- 9/17/21 - 1 form, 1 itemgroup, 14 items, 1 language
Itemgroup: Criteria
Evaluation of Patients With Breast Cancer Using DCE-MRI, MRS, and Proteomics; ODM derived from: https://clinicaltrials.gov/show/NCT00656604

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