Browsing by Subject "Practice Guidelines as Topic"

Now showing 1 - 4 of 4
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    Criteria for evaluating response and outcome in clinical trials for children with juvenile myelomonocytic leukemia
    (Ferrata Storti Foundation, 2015-01) Niemeyer, Charlotte M.; Loh, Mignon L.; Cseh, Annamaria; Cooper, Todd; Dvorak, Christopher C.; Chan, Rebecca; Xicoy, Blanca; Germing, Ulrich; Kojima, Seiji; Manabe, Atsushi; Dworzak, Michael; De Moerloose, Barbara; Starý, Jan; Smith, Owen P.; Masetti, Riccardo; Catala, Albert; Bergstraesser, Eva; Ussowicz, Marek; Fabri, Oskana; Baruchel, André; Cavé, Hélène; Zwaan, Michel; Locatelli, Franco; Hasle, Henrik; van den Heuvel-Eibrink, Marry M.; Flotho, Christian; Yoshimi, Ayami; Department of Pediatrics, IU School of Medicine
    Juvenile myelomonocytic leukemia is a rare myeloproliferative disease in young children. While hematopoietic stem cell transplantation remains the only curative therapeutic option for most patients, children with juvenile myelomonocytic leukemia increasingly receive novel agents in phase I-II clinical trials as pre-transplant therapy or therapy for relapse after transplantation. However, response criteria or definitions of outcome for standardized evaluation of treatment effect in patients with juvenile myelomonocytic leukemia are currently lacking. Here we propose criteria to evaluate the response to the non-transplant therapy and definitions of remission status after hematopoietic stem cell transplantation. For the evaluation of non-transplant therapy, we defined 6 clinical variables (white blood cell count, platelet count, hematopoietic precursors and blasts in peripheral blood, bone marrow blast percentage, spleen size and extramedullary disease) and 3 genetic variables (cytogenetic, molecular and chimerism response) which serve to describe the heterogeneous picture of response to therapy in each individual case. It is hoped that these criteria will facilitate the comparison of results between clinical trials in juvenile myelomonocytic leukemia.
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    International Cognition and Cancer Task Force Recommendations for Neuroimaging Methods in the Study of Cognitive Impairment in Non-CNS Cancer Patients
    (Oxford University Press, 2018-03) Deprez, Sabine; Kesler, Shelli R.; Saykin, Andrew J.; Silverman, Daniel H. S.; de Ruiter, Michiel B.; McDonald, Brenna C.; Radiology & Imaging Sciences, IU School of Medicine
    Cancer- and treatment-related cognitive changes have been a focus of increasing research since the early 1980s, with meta-analyses demonstrating poorer performance in cancer patients in cognitive domains including executive functions, processing speed, and memory. To facilitate collaborative efforts, in 2011 the International Cognition and Cancer Task Force (ICCTF) published consensus recommendations for core neuropsychological tests for studies of cancer populations. Over the past decade, studies have used neuroimaging techniques, including structural and functional magnetic resonance imaging (fMRI) and positron emission tomography, to examine the underlying brain basis for cancer- and treatment-related cognitive declines. As yet, however, there have been no consensus recommendations to guide researchers new to this field or to promote the ability to combine data sets. We first discuss important methodological issues with regard to neuroimaging study design, scanner considerations, and sequence selection, focusing on concerns relevant to cancer populations. We propose a minimum recommended set of sequences, including a high-resolution T1-weighted volume and a resting state fMRI scan. Additional advanced imaging sequences are discussed for consideration when feasible, including task-based fMRI and diffusion tensor imaging. Important image data processing and analytic considerations are also reviewed. These recommendations are offered to facilitate increased use of neuroimaging in studies of cancer- and treatment-related cognitive dysfunction. They are not intended to discourage investigator-initiated efforts to develop cutting-edge techniques, which will be helpful in advancing the state of the knowledge. Use of common imaging protocols will facilitate multicenter and data-pooling initiatives, which are needed to address critical mechanistic research questions.
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    Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration
    (Oxford University Press, 2015-07) Bossuyt, V.; Provenzano, E.; Symmans, W. F.; Boughey, J. C.; Coles, C.; Curigliano, G.; Dixon, J. M.; Esserman, L. J.; Fastner, G.; Kuehn, T.; Peintinger, F.; von Minckwitz, G.; White, J.; Yang, W.; Badve, Sunil; Denkert, C.; MacGrogan, G.; Penault-Llorca, F.; Viale, G.; Cameron, D.; Breast International Group-North American Breast Cancer Group (BIG-NABCG) collaboration; Department of Pathology and Laboratory Medicine, IU School of Medicine
    Neoadjuvant systemic therapy (NAST) provides the unique opportunity to assess response to treatment after months rather than years of follow-up. However, significant variability exists in methods of pathologic assessment of response to NAST, and thus its interpretation for subsequent clinical decisions. Our international multidisciplinary working group was convened by the Breast International Group-North American Breast Cancer Group (BIG-NABCG) collaboration and tasked to recommend practical methods for standardized evaluation of the post-NAST surgical breast cancer specimen for clinical trials that promote accurate and reliable designation of pathologic complete response (pCR) and meaningful characterization of residual disease. Recommendations include multidisciplinary communication; clinical marking of the tumor site (clips); and radiologic, photographic, or pictorial imaging of the sliced specimen, to map the tissue sections and reconcile macroscopic and microscopic findings. The information required to define pCR (ypT0/is ypN0 or ypT0 yp N0), residual ypT and ypN stage using the current AJCC/UICC system, and the Residual Cancer Burden system were recommended for quantification of residual disease in clinical trials.
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    The value of information and the ethics of personal-genomic screening.
    (The American Journal of Bioethics: AJOB, 2009-04) Schwartz, Peter H.
    Personal genomic screening, especially when marketed direct-to-consumers, threatens to worsen the inefficient use of healthcare resources that Burger and Kass discuss in the case of unproven screening tests. The information that genomic and other screening tests can provide may well have value for many patients, but its effective use in healthcare depends on careful thought about the ethics of testing and the proper regulation of unproven interventions.