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3. Baseline characteristics including blood and urine metal levels in the Trial to Assess Chelation Therapy 2 (TACT2)

Author

Navas-Acien, Ana, Santella, Regina M., Joubert, Bonnie R., Huang, Zhen, Lokhnygina, Yuliya, Ujueta, Francisco, Gurvich, Irina, LoIacono, Nancy J., Ravalli, Filippo, Ward, Cynthia D., Jarrett, Jeffery M., Salazar, Alfonsina De Leon, Boineau, Robin, Jones, Teresa L.Z., Mark, Daniel B., Newman, Jonathan D., Nathan, David M., Anstrom, Kevin J., and Lamas, Gervasio A.

Published
2024
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6. The trial to assess chelation therapy 2 (TACT2): Rationale and design

Author

Lamas, Gervasio A., Anstrom, Kevin J., Navas-Acien, Ana, Boineau, Robin, Kim, Hwasoon, Rosenberg, Yves, Stylianou, Mario, Jones, Teresa L.Z., Joubert, Bonnie R., Santella, Regina M., Escolar, Esteban, Aude, Y. Wady, Fonseca, Vivian, Elliott, Thomas, Lewis, Eldrin F., Farkouh, Michael E., Nathan, David M., Mon, Ana C., Gosnell, Leigh, Newman, Jonathan D., and Mark, Daniel B.

Published
2022
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13. Edetate Disodium–Based Chelation for Patients With a Previous Myocardial Infarction and Diabetes: TACT2 Randomized Clinical Trial.

Author

Lamas, Gervasio A., Anstrom, Kevin J., Navas-Acien, Ana, Boineau, Robin, Nemeth, Hayley, Huang, Zhen, Wen, Jun, Rosenberg, Yves, Stylianou, Mario, Jones, Teresa L. Z., Joubert, Bonnie R., Yu, Qilu, Santella, Regina M., Mon, Ana C., Ujueta, Francisco, Escolar, Esteban, Nathan, David M., Fonseca, Vivian A., Aude, Y. Wady, and Ehrman, Jonathan K.

Subjects
MAJOR adverse cardiovascular events, MYOCARDIAL infarction, CORONARY artery disease, MINERAL supplements, CHELATION therapy
Abstract

Key Points: Question: Does therapy with edetate disodium (EDTA)–based chelation reduce major adverse cardiovascular events compared with placebo infusions among patients with diabetes and prior myocardial infarction (MI)? Findings: EDTA-based chelation did not reduce major adverse cardiovascular events compared with placebo infusion, with a hazard ratio of 0.93 (95% CI, 0.76-1.16; P =.53). Chelation infusions did reduce the median blood lead levels from 9.0 μg/L at baseline to 3.5 μg/L at infusion 40 (P <.001). Meaning: Among patients with diabetes and prior MI, EDTA-based chelation decreased median blood lead levels by 61% from baseline but did not reduce major adverse cardiovascular events. Importance: In 2013, the Trial to Assess Chelation Therapy (TACT) reported that edetate disodium (EDTA)–based chelation significantly reduced cardiovascular disease (CVD) events by 18% in 1708 patients with a prior myocardial infarction (MI). Objective: To replicate the finding of TACT in individuals with diabetes and previous MI. Design, Setting, and Participants: A 2 × 2 factorial, double-masked, placebo-controlled, multicenter trial at 88 sites in the US and Canada, involving participants who were 50 years or older, had diabetes, and had experienced an MI at least 6 weeks before recruitment compared the effect of EDTA-based chelation vs placebo infusions on CVD events and compared the effect of high doses of oral multivitamins and minerals with oral placebo. This article reports on the chelation vs placebo infusion comparisons. Interventions: Eligible participants were randomly assigned to 40 weekly infusions of an EDTA-based chelation solution or matching placebo and to twice daily oral, high-dose multivitamin and mineral supplements or matching placebo for 60 months. This article addresses the chelation study. Main Outcomes and Measures: The primary end point was the composite of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina. Median follow-up was 48 months. Primary comparisons were made from patients who received at least 1 assigned infusion. Results: Of the 959 participants (median age, 67 years [IQR, 60-72 years]; 27% females; 78% White, 10% Black, and 20% Hispanic), 483 received at least 1 chelation infusion and 476 at least 1 placebo infusion. A primary end point event occurred in 172 participants (35.6%) in the chelation group and in 170 (35.7%) in the placebo group (adjusted hazard ratio [HR], 0.93; 95% CI, 0.76-1.16; P =.53). The 5-year primary event cumulative incidence rates were 45.8% for the chelation group and 46.5% for the placebo group. CV death, MI, or stroke events occurred in 89 participants (18.4%) in the chelation group and in 94 (19.7%) in the placebo group (adjusted HR, 0.89; 95% CI, 0.66-1.19). Death from any cause occurred in 84 participants (17.4%) in the chelation group and in 84 (17.6%) in the placebo group (adjusted HR, 0.96; 95% CI, 0.71-1.30). Chelation reduced median blood lead levels from 9.03 μg/L at baseline to 3.46 μg/L at infusion 40 (P <.001). Corresponding levels in the placebo group were 9.3 μg/L and 8.7 μg/L, respectively. Conclusions and Relevance: Despite effectively reducing blood lead levels, EDTA chelation was not effective in reducing cardiovascular events in stable patients with coronary artery disease who have diabetes and a history of MI. Trial Registration: ClinicalTrials.gov Identifier: NCT02733185 This randomized clinical trial assesses whether edetate disodium–based chelation infusions decrease cardiovascular disease events compared with placebo among patients with diabetes and prior myocardial infarction. [ABSTRACT FROM AUTHOR]

Published
2024
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14. Tumor detection by analysis of both symmetric- and hemi-methylation of plasma cell-free DNA.

Author

Hua, Xu, Zhou, Hui, Wu, Hui-Chen, Furnari, Julia, Kotidis, Corina P., Rabadan, Raul, Genkinger, Jeanine M., Bruce, Jeffrey N., Canoll, Peter, Santella, Regina M., and Zhang, Zhiguo

Subjects
CELL-free DNA, MACHINE learning, CIRCULATING tumor DNA, PLASMA cells, BRAIN cancer, DNA methylation, HEMICELLULOSE
Abstract

Aberrant DNA methylation patterns have been used for cancer detection. However, DNA hemi-methylation, present at about 10% CpG dinucleotides, has been less well studied. Here we show that a majority of differentially hemi-methylated regions (DHMRs) in liver tumor DNA or plasma cells free (cf) DNA do not overlap with differentially methylated regions (DMRs) of the same samples, indicating that DHMRs could serve as independent biomarkers. Furthermore, we analyzed the cfDNA methylomes of 215 samples from individuals with liver or brain cancer and individuals without cancer (controls), and trained machine learning models using DMRs, DHMRs or both. The models incorporated with both DMRs and DHMRs show a superior performance compared to models trained with DMRs or DHMRs, with AUROC being 0.978, 0.990, and 0.983 in distinguishing control, liver and brain cancer, respectively, in a validation cohort. This study supports the potential of utilizing both DMRs and DHMRs for multi-cancer detection. Alterations in DNA methylation patterns are known as predictors of cancer diagnosis. Here, the authors develop a method to analyze both symmetric- and hemi-methylated regions in plasma cell free DNA and show its utility in detecting both liver and brain cancer. [ABSTRACT FROM AUTHOR]

Published
2024
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17. A case-only study to identify genetic modifiers of breast cancer risk for BRCA1/BRCA2 mutation carriers

Author

Coignard, Juliette, Lush, Michael, Beesley, Jonathan, O’Mara, Tracy A., Dennis, Joe, Tyrer, Jonathan P., Barnes, Daniel R., McGuffog, Lesley, Leslie, Goska, Bolla, Manjeet K., Adank, Muriel A., Agata, Simona, Ahearn, Thomas, Aittomäki, Kristiina, Andrulis, Irene L., Anton-Culver, Hoda, Arndt, Volker, Arnold, Norbert, Aronson, Kristan J., Arun, Banu K., Augustinsson, Annelie, Azzollini, Jacopo, Barrowdale, Daniel, Baynes, Caroline, Becher, Heiko, Bermisheva, Marina, Bernstein, Leslie, Białkowska, Katarzyna, Blomqvist, Carl, Bojesen, Stig E., Bonanni, Bernardo, Borg, Ake, Brauch, Hiltrud, Brenner, Hermann, Burwinkel, Barbara, Buys, Saundra S., Caldés, Trinidad, Caligo, Maria A., Campa, Daniele, Carter, Brian D., Castelao, Jose E., Chang-Claude, Jenny, Chanock, Stephen J., Chung, Wendy K., Claes, Kathleen B. M., Clarke, Christine L., Collée, J. Margriet, Conroy, Don M., Czene, Kamila, Daly, Mary B., Devilee, Peter, Diez, Orland, Ding, Yuan Chun, Domchek, Susan M., Dörk, Thilo, dos-Santos-Silva, Isabel, Dunning, Alison M., Dwek, Miriam, Eccles, Diana M., Eliassen, A. Heather, Engel, Christoph, Eriksson, Mikael, Evans, D. Gareth, Fasching, Peter A., Flyger, Henrik, Fostira, Florentia, Friedman, Eitan, Fritschi, Lin, Frost, Debra, Gago-Dominguez, Manuela, Gapstur, Susan M., Garber, Judy, Garcia-Barberan, Vanesa, García-Closas, Montserrat, García-Sáenz, José A., Gaudet, Mia M., Gayther, Simon A., Gehrig, Andrea, Georgoulias, Vassilios, Giles, Graham G., Godwin, Andrew K., Goldberg, Mark S., Goldgar, David E., González-Neira, Anna, Greene, Mark H., Guénel, Pascal, Haeberle, Lothar, Hahnen, Eric, Haiman, Christopher A., Håkansson, Niclas, Hall, Per, Hamann, Ute, Harrington, Patricia A., Hart, Steven N., He, Wei, Hogervorst, Frans B. L., Hollestelle, Antoinette, Hopper, John L., Horcasitas, Darling J., Hulick, Peter J., Hunter, David J., Imyanitov, Evgeny N., Jager, Agnes, Jakubowska, Anna, James, Paul A., Jensen, Uffe Birk, John, Esther M., Jones, Michael E., Kaaks, Rudolf, Kapoor, Pooja Middha, Karlan, Beth Y., Keeman, Renske, Khusnutdinova, Elza, Kiiski, Johanna I., Ko, Yon-Dschun, Kosma, Veli-Matti, Kraft, Peter, Kurian, Allison W., Laitman, Yael, Lambrechts, Diether, Le Marchand, Loic, Lester, Jenny, Lesueur, Fabienne, Lindstrom, Tricia, Lopez-Fernández, Adria, Loud, Jennifer T., Luccarini, Craig, Mannermaa, Arto, Manoukian, Siranoush, Margolin, Sara, Martens, John W. M., Mebirouk, Noura, Meindl, Alfons, Miller, Austin, Milne, Roger L., Montagna, Marco, Nathanson, Katherine L., Neuhausen, Susan L., Nevanlinna, Heli, Nielsen, Finn C., O’Brien, Katie M., Olopade, Olufunmilayo I., Olson, Janet E., Olsson, Håkan, Osorio, Ana, Ottini, Laura, Park-Simon, Tjoung-Won, Parsons, Michael T., Pedersen, Inge Sokilde, Peshkin, Beth, Peterlongo, Paolo, Peto, Julian, Pharoah, Paul D. P., Phillips, Kelly-Anne, Polley, Eric C., Poppe, Bruce, Presneau, Nadege, Pujana, Miquel Angel, Punie, Kevin, Radice, Paolo, Rantala, Johanna, Rashid, Muhammad U., Rennert, Gad, Rennert, Hedy S., Robson, Mark, Romero, Atocha, Rossing, Maria, Saloustros, Emmanouil, Sandler, Dale P., Santella, Regina, Scheuner, Maren T., Schmidt, Marjanka K., Schmidt, Gunnar, Scott, Christopher, Sharma, Priyanka, Soucy, Penny, Southey, Melissa C., Spinelli, John J., Steinsnyder, Zoe, Stone, Jennifer, Stoppa-Lyonnet, Dominique, Swerdlow, Anthony, Tamimi, Rulla M., Tapper, William J., Taylor, Jack A., Terry, Mary Beth, Teulé, Alex, Thull, Darcy L., Tischkowitz, Marc, Toland, Amanda E., Torres, Diana, Trainer, Alison H., Truong, Thérèse, Tung, Nadine, Vachon, Celine M., Vega, Ana, Vijai, Joseph, Wang, Qin, Wappenschmidt, Barbara, Weinberg, Clarice R., Weitzel, Jeffrey N., Wendt, Camilla, Wolk, Alicja, Yadav, Siddhartha, Yang, Xiaohong R., Yannoukakos, Drakoulis, Zheng, Wei, Ziogas, Argyrios, Zorn, Kristin K., Park, Sue K., Thomassen, Mads, Offit, Kenneth, Schmutzler, Rita K., Couch, Fergus J., Simard, Jacques, Chenevix-Trench, Georgia, Easton, Douglas F., Andrieu, Nadine, and Antoniou, Antonis C.

Published
2021
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28. Urinary Androgens Provide Additional Evidence Related to Metabolism and Are Correlated With Serum Androgens in Girls.

Author

Scott, Sasinya N, Siguencia, Marvin, Stanczyk, Frank Z, Hartmann, Michaela F, Wudy, Stefan A, White, Melissa, Chung, Wendy K, Santella, Regina M, Terry, Mary Beth, and Houghton, Lauren C

Subjects
ANDROGENS, PEARSON correlation (Statistics), HAIR growth, OLDER men, TEENAGE girls
Abstract

Context Androgen levels are generally measured in serum samples, but urine may be a more feasible option, especially in children, as it is a noninvasive alternative. Objective To assess the correlations of 10 urinary androgen metabolites with 4 serum androgens [dehydroepiandrosterone-sulfate (DHEA-S), androstenedione, and total and free testosterone] and assess if their correlations differ by participant characteristics. Methods Our study consisted of 44 girls, ages 6-13, who participated in the New York site of the LEGACY Girls Study and had both serum and urine samples collected at the same visit. We performed Pearson's correlation coefficient tests between 4 serum and 10 individual urinary metabolite measures and their sum. We examined the influence of participant characteristics on the magnitude and direction of the correlations. Results The summed urinary metabolite measures had the highest correlation with free testosterone in serum (global sum, r = 0.83) and correlated least with DHEA-S in serum (global sum, r = 0.64). The correlation between individual urinary metabolites and serum androgens ranged from 0.08 to 0.84.Two 11-oxygenated urinary metabolites (5α-androstane-3α-ol-11,17-dione5β-androstane-3α,11β-diol-17-one) were weakly correlated with all serum androgens. Participant age, weight, height, waist:hip ratio, and pubic hair growth stage changed the correlations between urinary and serum androgens measures between 10% and 213%. Conclusion The sum of urinary androgen metabolites was a good marker of circulating androstenedione, testosterone, and free testosterone. Individual urinary metabolites provide additional information about the metabolic processes of disease development compared to the antecedent serum androgens. [ABSTRACT FROM AUTHOR]

Published
2024
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31. Association of genetic susceptibility variants for type 2 diabetes with breast cancer risk in women of European ancestry

Author

Zhao, Zhiguo, Wen, Wanqing, Michailidou, Kyriaki, Bolla, Manjeet K., Wang, Qin, Zhang, Ben, Long, Jirong, Shu, Xiao-Ou, Schmidt, Marjanka K., Milne, Roger L., García-Closas, Montserrat, Chang-Claude, Jenny, Lindstrom, Sara, Bojesen, Stig E., Ahsan, Habibul, Aittomäki, Kristiina, Andrulis, Irene L., Anton-Culver, Hoda, Arndt, Volker, Beckmann, Matthias W., Beeghly-Fadiel, Alicia, Benitez, Javier, Blomqvist, Carl, Bogdanova, Natalia V., Børresen-Dale, Anne-Lise, Brand, Judith, Brauch, Hiltrud, Brenner, Hermann, Burwinkel, Barbara, Cai, Qiuyin, Casey, Graham, Chenevix-Trench, Georgia, Couch, Fergus J., Cox, Angela, Cross, Simon S., Czene, Kamila, Dörk, Thilo, Dumont, Martine, Fasching, Peter A., Figueroa, Jonine, Flesch-Janys, Dieter, Fletcher, Olivia, Flyger, Henrik, Fostira, Florentia, Gammon, Marilie, Giles, Graham G., Guénel, Pascal, Haiman, Christopher A., Hamann, Ute, Harrington, Patricia, Hartman, Mikael, Hooning, Maartje J., Hopper, John L., Jakubowska, Anna, Jasmine, Farzana, John, Esther M., Johnson, Nichola, Kabisch, Maria, Khan, Sofia, Kibriya, Muhammad, Knight, Julia A., Kosma, Veli-Matti, Kriege, Mieke, Kristensen, Vessela, Le Marchand, Loic, Lee, Eunjung, Li, Jingmei, Lindblom, Annika, Lophatananon, Artitaya, Luben, Robert, Lubinski, Jan, Malone, Kathleen E., Mannermaa, Arto, Manoukian, Siranoush, Margolin, Sara, Marme, Frederik, McLean, Catriona, Meijers-Heijboer, Hanne, Meindl, Alfons, Miao, Hui, Muir, Kenneth, Neuhausen, Susan L., Nevanlinna, Heli, Neven, Patrick, Olson, Janet E., Perkins, Barbara, Peterlongo, Paolo, Phillips, Kelly-Anne, Pylkäs, Katri, Rudolph, Anja, Santella, Regina, Sawyer, Elinor J., Schmutzler, Rita K., Schoemaker, Minouk, Shah, Mitul, Shrubsole, Martha, Southey, Melissa C., Swerdlow, Anthony J., Toland, Amanda E., Tomlinson, Ian, Torres, Diana, Truong, Thérèse, Ursin, Giske, Van Der Luijt, Rob B., Verhoef, Senno, Wang-Gohrke, Shan, Whittemore, Alice S., Winqvist, Robert, Zamora, M. Pilar, Zhao, Hui, Dunning, Alison M., Simard, Jacques, Hall, Per, Kraft, Peter, Pharoah, Paul, Hunter, David, Easton, Douglas F., and Zheng, Wei

Published
2016

38. Associations between polymorphisms in genes related to estrogen metabolism and function and prostate cancer risk: results from the Prostate Cancer Prevention Trial

Author

Tang, Li, Platek, Mary E, Yao, Song, Till, Cathee, Goodman, Phyllis J, Tangen, Catherine M, Wu, Yue, Platz, Elizabeth A, Neuhouser, Marian L, Stanczyk, Frank Z, Reichardt, Juergen K V, Santella, Regina M, Hsing, Ann, Figg, William D, Lippman, Scott M, Thompson, Ian M, and Ambrosone, Christine B

Published
2018
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40. Primary lateral sclerosis natural history study – planning, designing, and early enrollment.

Author

Mitsumoto, Hiroshi, Jang, Grace, Lee, Ikjae, Simmons, Zachary, Sherman, Alexander V., Heitzman, Daragh, Sorenson, Eric, Cheung, Ken, Andrews, Jinsy, Harms, Matthew, Shneider, Neil A., Santella, Regina, Paganoni, Sabrina, Ajroud-Driss, Senda, Fernandes, J. Americo M., Burke, Katherine M., Gwathmey, Kelly, Habib, Ali A., Maragakis, Nicholas J., and Walk, David

Subjects
AMYOTROPHIC lateral sclerosis, NATURAL history, MOTOR neuron diseases, DISEASE duration, DISEASE progression
Abstract

Introduction/Aims. Primary lateral sclerosis (PLS) is exceedingly rare and has been an enigmatic disease. Recent progress has drastically changed this perception, with early biomarkers being investigated and potential medications for PLS emerging at the preclinical stage. The aim of this paper is to describe a study of PLS natural history and discuss the limitations and proposed solutions to the study of a rare and slowly progressive disease. Methods. The PLS Natural History Study is a 30-site, 24-month, prospective study that is supported by multiple funding sources. The study aims to enroll 50 early PLS (disease duration ≤4 years) and 50 definite PLS (disease duration 4 to 15 years) participants using modified PLS Diagnostic Criteria. Smartphone-based assessments including semi-quantitative and quantitative measures and patient-reported outcomes are utilized. In-person quantitative measures are also completed during site visits. The change in the PLS Functional Rating Scale score is the primary outcome. The study utilizes the NeuroBANK® patient-centric data capture and management platform. The biostatistical analysis plan has been developed. Results. In one year, 28 participants have been recruited. Enrollment has been much slower than anticipated due to the COVID-19 pandemic, the rarity of PLS, and potential study competition for internal resources from ALS clinical trials. Discussion. We discuss the need for more innovative methods to enroll and study individuals with such rare diseases and propose a number of mechanisms by which more efficient enrollment could be facilitated. [ABSTRACT FROM AUTHOR]

Published
2023
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41. High‐throughput measurement of double strand break global repair phenotype in peripheral blood mononuclear cells after long‐term cryopreservation.

Author

Bacon, Bezalel, Repin, Mikhail, Shuryak, Igor, Wu, Hui‐Chen, Santella, Regina M., Terry, Mary Beth, Brenner, David J., and Turner, Helen C.

Abstract

Peripheral blood mononuclear cells (PBMCs) are a useful model for biochemical assays, particularly for etiological studies. We describe here a method for measuring DNA repair capacity (DRC) in archival cryogenically preserved PBMCs. To model DRC, we measured γ‐H2AX repair kinetics in thawed PBMCs after irradiation with 3 Gy gamma rays. Time‐dependent fluorescently labeled γ‐H2AX levels were measured at five time points from 1 to 20 h, yielding an estimate of global DRC repair kinetics as well as a measure of unrepaired double strand breaks at 20 h. While γ‐H2AX levels are traditionally measured by either microscopy or flow‐cytometry, we developed a protocol for imaging flow cytometry (IFC) that combines the detailed information of microscopy with the statistical power of flow methods. The visual imaging component of the IFC allows for monitoring aspects such as cellular health and apoptosis as well as fluorescence localization of the γ‐H2AX signal, which ensures the power and significance of this technique. Application of a machine‐learning based image classification improved flow cytometry fluorescent measurements by identifying apoptotic cells unable to undergo DNA repair. We present here DRC repair parameters from 18 frozen archival PBMCs and 28 fresh blood samples collected from a demographically diverse cohort of women measured in a high‐throughput IFC format. This thaw method and assay can be used alone or in conjunction with other assays to measure etiological phenotypes in cryogenic biobanks of PBMCs. [ABSTRACT FROM AUTHOR]

Published
2023
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50. Serum estrogen levels and prostate cancer risk in the prostate cancer prevention trial: a nested case-control study

Author

Yao, Song, Till, Cathee, Kristal, Alan R., Goodman, Phyllis J., Hsing, Ann W., Tangen, Catherine M., Platz, Elizabeth A., Stanczyk, Frank Z., Reichardt, Juergen K. V., Tang, Li, Neuhouser, Marian L., Santella, Regina M., Figg, William D., Price, Douglas K., Parnes, Howard L., Lippman, Scott M., Thompson, Ian M., Ambrosone, Christine B., and Hoque, Ashraful

Published
2011

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