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Consensus on biomarkers for neuroendocrine tumour disease.
Oberg K, Modlin IM, De Herder W, Pavel M, Klimstra D, Frilling A, Metz DC, Heaney A, Kwekkeboom D, Strosberg J, Meyer T, Moss SF, Washington K, Wolin E, Liu E, Goldenring J
(2015) Lancet Oncol 16: e435-e446
MeSH Terms: Biomarkers, Tumor, Delphi Technique, Humans, MicroRNAs, National Cancer Institute (U.S.), Neoplastic Cells, Circulating, Neuroendocrine Tumors, Prognosis, United States
Show Abstract · Added April 12, 2016
Management of neuroendocrine neoplasia represents a clinical challenge because of its late presentation, lack of treatment options, and limitations in present imaging modalities and biomarkers to guide management. Monoanalyte biomarkers have poor sensitivity, specificity, and predictive ability. A National Cancer Institute summit, held in 2007, on neuroendocrine tumours noted biomarker limitations to be a crucial unmet need in the management of neuroendocrine tumours. A multinational consensus meeting of multidisciplinary experts in neuroendocrine tumours assessed the use of current biomarkers and defined the perquisites for novel biomarkers via the Delphi method. Consensus (at >75%) was achieved for 88 (82%) of 107 assessment questions. The panel concluded that circulating multianalyte biomarkers provide the highest sensitivity and specificity necessary for minimum disease detection and that this type of biomarker had sufficient information to predict treatment effectiveness and prognosis. The panel also concluded that no monoanalyte biomarker of neuroendocrine tumours has yet fulfilled these criteria and there is insufficient information to support the clinical use of miRNA or circulating tumour cells as useful prognostic markers for this disease. The panel considered that trials measuring multianalytes (eg, neuroendocrine gene transcripts) should also identify how such information can optimise the management of patients with neuroendocrine tumours.
Copyright © 2015 Elsevier Ltd. All rights reserved.
0 Communities
1 Members
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9 MeSH Terms
Genomic Classification of Cutaneous Melanoma.
Cancer Genome Atlas Network
(2015) Cell 161: 1681-96
MeSH Terms: Databases, Genetic, Humans, Melanoma, Mutation, National Cancer Institute (U.S.), Skin Neoplasms, United States
Show Abstract · Added August 8, 2016
We describe the landscape of genomic alterations in cutaneous melanomas through DNA, RNA, and protein-based analysis of 333 primary and/or metastatic melanomas from 331 patients. We establish a framework for genomic classification into one of four subtypes based on the pattern of the most prevalent significantly mutated genes: mutant BRAF, mutant RAS, mutant NF1, and Triple-WT (wild-type). Integrative analysis reveals enrichment of KIT mutations and focal amplifications and complex structural rearrangements as a feature of the Triple-WT subtype. We found no significant outcome correlation with genomic classification, but samples assigned a transcriptomic subclass enriched for immune gene expression associated with lymphocyte infiltrate on pathology review and high LCK protein expression, a T cell marker, were associated with improved patient survival. This clinicopathological and multi-dimensional analysis suggests that the prognosis of melanoma patients with regional metastases is influenced by tumor stroma immunobiology, offering insights to further personalize therapeutic decision-making.
Copyright © 2015 Elsevier Inc. All rights reserved.
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7 MeSH Terms
Letter to cancer center directors: Progress in quantitative imaging as a means to predict and/or measure tumor response in cancer therapy trials.
Mountz JM, Yankeelov TE, Rubin DL, Buatti JM, Erikson BJ, Fennessy FM, Gillies RJ, Huang W, Jacobs MA, Kinahan PE, Laymon CM, Linden HM, Mankoff DA, Schwartz LH, Shim H, Wahl RL
(2014) J Clin Oncol 32: 2115-6
MeSH Terms: Antineoplastic Agents, Clinical Trials as Topic, Diagnostic Imaging, Disease Progression, Humans, Inflammation, National Cancer Institute (U.S.), Neoplasms, Predictive Value of Tests, Research Support as Topic, Treatment Outcome, United States
Added February 12, 2015
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12 MeSH Terms
The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: summary and recommendations.
Denicoff AM, McCaskill-Stevens W, Grubbs SS, Bruinooge SS, Comis RL, Devine P, Dilts DM, Duff ME, Ford JG, Joffe S, Schapira L, Weinfurt KP, Michaels M, Raghavan D, Richmond ES, Zon R, Albrecht TL, Bookman MA, Dowlati A, Enos RA, Fouad MN, Good M, Hicks WJ, Loehrer PJ, Lyss AP, Wolff SN, Wujcik DM, Meropol NJ
(2013) J Oncol Pract 9: 267-76
MeSH Terms: Attitude of Health Personnel, Clinical Trials as Topic, Humans, Leadership, Medical Oncology, National Cancer Institute (U.S.), Neoplasms, Patient Education as Topic, Patient Selection, Practice Patterns, Physicians', Societies, Medical, United States
Show Abstract · Added March 7, 2014
INTRODUCTION - Many challenges to clinical trial accrual exist, resulting in studies with inadequate enrollment and potentially delaying answers to important scientific and clinical questions.
METHODS - The National Cancer Institute (NCI) and the American Society of Clinical Oncology (ASCO) cosponsored the Cancer Trial Accrual Symposium: Science and Solutions on April 29-30, 2010 to examine the state of accrual science related to patient/community, physician/provider, and site/organizational influences, and identify new interventions to facilitate clinical trial enrollment. The symposium featured breakout sessions, plenary sessions, and a poster session including 100 abstracts. Among the 358 attendees were clinical investigators, researchers of accrual strategies, research administrators, nurses, research coordinators, patient advocates, and educators. A bibliography of the accrual literature in these three major areas was provided to participants in advance of the meeting. After the symposium, the literature in these areas was revisited to determine if the symposium recommendations remained relevant within the context of the current literature.
RESULTS - Few rigorously conducted studies have tested interventions to address challenges to clinical trials accrual. Attendees developed recommendations for improving accrual and identified priority areas for future accrual research at the patient/community, physician/provider, and site/organizational levels. Current literature continues to support the symposium recommendations.
CONCLUSIONS - A combination of approaches addressing both the multifactorial nature of accrual challenges and the characteristics of the target population may be needed to improve accrual to cancer clinical trials. Recommendations for best practices and for future research developed from the symposium are provided.
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12 MeSH Terms
Connecting genomic alterations to cancer biology with proteomics: the NCI Clinical Proteomic Tumor Analysis Consortium.
Ellis MJ, Gillette M, Carr SA, Paulovich AG, Smith RD, Rodland KK, Townsend RR, Kinsinger C, Mesri M, Rodriguez H, Liebler DC, Clinical Proteomic Tumor Analysis Consortium (CPTAC)
(2013) Cancer Discov 3: 1108-12
MeSH Terms: Biomarkers, Tumor, Breast Neoplasms, Colonic Neoplasms, Computational Biology, Female, Genome, Human, Genomics, Genotype, Humans, Molecular Sequence Annotation, Mutation, National Cancer Institute (U.S.), National Human Genome Research Institute (U.S.), Neoplasms, Ovarian Neoplasms, Phenotype, Proteomics, United States
Show Abstract · Added March 20, 2014
The National Cancer Institute (NCI) Clinical Proteomic Tumor Analysis Consortium is applying the latest generation of proteomic technologies to genomically annotated tumors from The Cancer Genome Atlas (TCGA) program, a joint initiative of the NCI and the National Human Genome Research Institute. By providing a fully integrated accounting of DNA, RNA, and protein abnormalities in individual tumors, these datasets will illuminate the complex relationship between genomic abnormalities and cancer phenotypes, thus producing biologic insights as well as a wave of novel candidate biomarkers and therapeutic targets amenable to verification using targeted mass spectrometry methods.
©2013 AACR.
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18 MeSH Terms
Operationalization of community-based participatory research principles: assessment of the national cancer institute's community network programs.
Braun KL, Nguyen TT, Tanjasiri SP, Campbell J, Heiney SP, Brandt HM, Smith SA, Blumenthal DS, Hargreaves M, Coe K, Ma GX, Kenerson D, Patel K, Tsark J, Hébert JR
(2012) Am J Public Health 102: 1195-203
MeSH Terms: Community Networks, Community-Based Participatory Research, Community-Institutional Relations, Guideline Adherence, Humans, National Cancer Institute (U.S.), Research Design, Surveys and Questionnaires, United States
Show Abstract · Added March 27, 2014
OBJECTIVES - We examined how National Cancer Institute-funded Community Network Programs (CNPs) operationalized principles of community-based participatory research (CBPR).
METHODS - We reviewed the literature and extant CBPR measurement tools. On the basis of that review, we developed a 27-item questionnaire for CNPs to self-assess their operationalization of 9 CBPR principles. Our team comprised representatives of 9 of the National Cancer Institute's 25 CNPs.
RESULTS - Of the 25 CNPs, 22 (88%) completed the questionnaire. Most scored well on CBPR principles of recognizing community as a unit of identity, building on community strengths, facilitating colearning, embracing iterative processes in developing community capacity, and achieving a balance between data generation and intervention. CNPs varied in the extent to which they employed CBPR principles of addressing determinants of health, sharing power among partners, engaging the community in research dissemination, and striving for sustainability.
CONCLUSIONS - Although the development of assessment tools in this field is in its infancy, our findings suggest that fidelity to CBPR processes can be assessed in a variety of settings.
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9 MeSH Terms
How confident are young adult cancer survivors in managing their survivorship care? A report from the LIVESTRONG™ Survivorship Center of Excellence Network.
Casillas J, Syrjala KL, Ganz PA, Hammond E, Marcus AC, Moss KM, Crespi CM, Lu P, McCabe MS, Ford JS, Jacobs LA, Pucci D, Palmer SC, Termuhlen AM, Diller L, Campbell M, Jones B, Friedman DL
(2011) J Cancer Surviv 5: 371-81
MeSH Terms: Adolescent, Adult, Delivery of Health Care, Female, Humans, Male, National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division, National Cancer Institute (U.S.), Neoplasms, Patient Care Planning, Socioeconomic Factors, Survival Rate, Survivors, United States, Young Adult
Show Abstract · Added March 27, 2014
INTRODUCTION - This study examined the association between sociodemographic, cancer treatment, and care delivery factors on young adult cancer survivors' confidence in managing their survivorship care.
METHODS - Survivors aged 18-39 years (n = 376) recruited from the LIVESTRONG™ Survivorship Center of Excellence Network sites completed a survey assessing self-reported receipt of survivorship care planning, expectations of their providers, and confidence in managing their survivorship care. Multivariate logistic regression identified characteristics of those reporting low confidence in managing their survivorship care.
RESULTS - Mean age was 28 years; mean interval from diagnosis was 9 ± 8 years. Seventy-one percent reported currently attending an oncology survivorship clinic. Regarding survivorship care planning, 33% did not have copies of their cancer-related medical records, 48% did not have a treatment summary, and 55% had not received a survivorship care plan. Seventy percent identified the oncologist as the most important health care provider for decisions regarding test and treatment decisions while 10% reported using a "shared-care model" involving both primary care providers and oncologists. Forty-one percent were classified as having low confidence in managing survivorship care. In multivariate analysis, low confidence was associated with non-white ethnicity and lack of a survivorship care plan (both p < 0.05).
DISCUSSION/CONCLUSIONS - Findings suggest that provision of survivorship care plans for young adult cancer survivors can be used to improve confidence in managing survivorship care, particularly for ethnic minorities.
IMPLICATIONS FOR CANCER SURVIVORS - Survivors should consider advocating for receipt of a survivorship care plan as it may facilitate confidence as a consumer of survivorship care.
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15 MeSH Terms
Recruitment of African Americans to National Oncology Clinical Trials through a clinical trial shared resource.
Wujcik D, Wolff SN
(2010) J Health Care Poor Underserved 21: 38-50
MeSH Terms: African Americans, Clinical Trials as Topic, Hospitals, General, Humans, Interinstitutional Relations, National Cancer Institute (U.S.), Neoplasms, Patient Selection, Schools, Medical, Tennessee, United States
Show Abstract · Added March 27, 2014
In 2000, using National Institutes of Health/National Cancer Institute (NIH/NCI) U54 funds, a clinical trials shared resource was established at Nashville General Hospital at Meharry to attract more African Americans to national cancer clinical trials. This Report from the Field describes the model used to achieve this end.
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11 MeSH Terms
Analytical validation of protein-based multiplex assays: a workshop report by the NCI-FDA interagency oncology task force on molecular diagnostics.
Rodriguez H, Tezak Z, Mesri M, Carr SA, Liebler DC, Fisher SJ, Tempst P, Hiltke T, Kessler LG, Kinsinger CR, Philip R, Ransohoff DF, Skates SJ, Regnier FE, Anderson NL, Mansfield E, Workshop Participants
(2010) Clin Chem 56: 237-43
MeSH Terms: Biomarkers, Tumor, Humans, Mass Spectrometry, National Cancer Institute (U.S.), Neoplasms, Proteomics, United States, United States Food and Drug Administration, Validation Studies as Topic
Show Abstract · Added March 20, 2014
Clinical proteomics has the potential to enable the early detection of cancer through the development of multiplex assays that can inform clinical decisions. However, there has been some uncertainty among translational researchers and developers as to the specific analytical measurement criteria needed to validate protein-based multiplex assays. To begin to address the causes of this uncertainty, a day-long workshop titled "Interagency Oncology Task Force Molecular Diagnostics Workshop" was held in which members of the proteomics and regulatory communities discussed many of the analytical evaluation issues that the field should address in development of protein-based multiplex assays for clinical use. This meeting report explores the issues raised at the workshop and details the recommendations that came out of the day's discussions, such as a workshop summary discussing the analytical evaluation issues that specific proteomic technologies should address when seeking US Food and Drug Administration approval.
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9 MeSH Terms
Consensus report of the national cancer institute clinical trials planning meeting on pancreas cancer treatment.
Philip PA, Mooney M, Jaffe D, Eckhardt G, Moore M, Meropol N, Emens L, O'Reilly E, Korc M, Ellis L, Benedetti J, Rothenberg M, Willett C, Tempero M, Lowy A, Abbruzzese J, Simeone D, Hingorani S, Berlin J, Tepper J
(2009) J Clin Oncol 27: 5660-9
MeSH Terms: Animals, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Pancreatic Ductal, Clinical Trials, Phase III as Topic, Combined Modality Therapy, Disease Models, Animal, Disease-Free Survival, Drug Delivery Systems, Female, Humans, Male, Mice, National Cancer Institute (U.S.), Neoplasm Invasiveness, Neoplasm Staging, Pancreatectomy, Pancreatic Neoplasms, Practice Guidelines as Topic, Prognosis, Risk Assessment, Survival Analysis, United States
Show Abstract · Added March 20, 2014
Pancreatic ductal adenocarcinoma (PDAC) is the fourth leading cause of cancer mortality, despite significant improvements in diagnostic imaging and operative mortality rates. The 5-year survival rate remains less than 5% because of microscopic or gross metastatic disease at time of diagnosis. The Clinical Trials Planning Meeting in pancreatic cancer was convened by the National Cancer Institute's Gastrointestinal Cancer Steering Committee to discuss the integration of basic and clinical knowledge in the design of clinical trials in PDAC. Major emphasis was placed on the enhancement of research to identify and validate the relevant targets and molecular pathways in PDAC, cancer stem cells, and the microenvironment. Emphasis was also placed on developing rational combinations of targeted agents and the development of predictive biomarkers to assist selection of patient subsets. The development of preclinical tumor models that are better predictive of human PDAC must be supported with wider availability to the research community. Phase III clinical trials should be implemented only if there is a meaningful clinical signal of efficacy and safety in the phase II setting. The emphasis must therefore be on performing well-designed phase II studies with uniform sets of basic entry and evaluation criteria with survival as a primary endpoint. Patients with either metastatic or locally advanced PDAC must be studied separately.
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22 MeSH Terms