{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,21]],"date-time":"2026-06-21T02:11:38Z","timestamp":1782007898177,"version":"3.54.5"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2022,4,1]],"date-time":"2022-04-01T00:00:00Z","timestamp":1648771200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,4,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>clinical trials dedicated to the older patients with cancer are essential to help to define optimal cancer therapy for this rapidly growing population. Our study aimed to analyse the characteristics and the evolution of older-patient-specific oncological trials registered in ClinicalTrials.gov.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>a dataset of 61,120 oncological trials registered in ClinicalTrials.gov between 2000 and 2019 was downloaded. Characteristics of older-patient-specific trials were compared with characteristics of age-unspecified trials. Chronological shifts in older-patient-specific trials were also analysed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>of the 49,273 interventional trials eligible for analysis, only 490 (1.0%) were older-patient-specific. More than half of the older-patient-specific trials were phase 2 and enrolled less than 100 patients. Compared with age-unspecified trials, older-patient-specific trials were less likely to be funded by industry (26.9 vs 37.1%), and more likely to be conducted in Europe (44.5 vs 28.3%). During the two time periods between 2000 and 2009, and 2010 and 2019, the proportion of supportive care-oriented trials increased from 1.9 to 13.9%. Concerningly, the use of clinically meaningful end points in older patients such as disease-specific survival, patient-reported outcomes and functional status as a primary end point was uncommon (0.4, 8.1 and 7.3%, respectively). There was no correlation between the number of trials for a given cancer type and relative incidence and mortality. 196\/490 (40.0%) of the trials were conducted for patients with haematological cancer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>our study helps us to better understand the current state of older-patient-specific oncological trials and provide insights for future development, resulting in the improvement of the care of older patients with cancer.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ageing\/afac087","type":"journal-article","created":{"date-parts":[[2022,3,19]],"date-time":"2022-03-19T08:07:47Z","timestamp":1647677267000},"source":"Crossref","is-referenced-by-count":5,"title":["Characteristics of older-patient-specif\u2009ic oncological trials: a cross-sectional analysis of ClinicalTrials.gov"],"prefix":"10.1093","volume":"51","author":[{"given":"Yun","family":"Yang","sequence":"first","affiliation":[{"name":"Department of Ultrasound Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hubei Province Clinical Research Center for Medical Imaging, Hubei Province Key Laboratory of Molecular Imaging, Wuhan 430022, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mingxing","family":"Xie","sequence":"additional","affiliation":[{"name":"Department of Ultrasound Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hubei Province Clinical Research Center for Medical Imaging, Hubei Province Key Laboratory of Molecular Imaging, Wuhan 430022, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Ultrasound Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hubei Province Clinical Research Center for Medical Imaging, Hubei Province Key Laboratory of Molecular Imaging, Wuhan 430022, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaixu","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Orthopedics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"He","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Ultrasound Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hubei Province Clinical Research Center for Medical Imaging, Hubei Province Key Laboratory of Molecular Imaging, Wuhan 430022, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Ultrasound Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hubei Province Clinical Research Center for Medical Imaging, Hubei Province Key Laboratory of Molecular Imaging, Wuhan 430022, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zishan","family":"Feng","sequence":"additional","affiliation":[{"name":"Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yun","family":"Tang","sequence":"additional","affiliation":[{"name":"Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haotian","family":"Ma","sequence":"additional","affiliation":[{"name":"Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qingpeng","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Ultrasound Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hubei Province Clinical Research Center for Medical Imaging, Hubei Province Key Laboratory of Molecular Imaging, Wuhan 430022, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gang","family":"Wu","sequence":"additional","affiliation":[{"name":"Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kunyu","family":"Yang","sequence":"additional","affiliation":[{"name":"Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4024-4291","authenticated-orcid":false,"given":"Bian","family":"Wu","sequence":"additional","affiliation":[{"name":"Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,4,14]]},"reference":[{"key":"2022041613311862900_ref1","doi-asserted-by":"crossref","first-page":"40","DOI":"10.4103\/apjon.apjon_52_17","article-title":"Cancer in the elderly: challenges and barriers","volume":"5","author":"Estap\u00e9","year":"2018","journal-title":"Asia Pac J Oncol Nurs"},{"key":"2022041613311862900_ref2","first-page":"275","article-title":"Geriatric oncology: problems with under-treatment within this population","volume":"12","author":"Swaminathan","year":"2015","journal-title":"Cancer Biol Med"},{"key":"2022041613311862900_ref3","doi-asserted-by":"crossref","first-page":"2061","DOI":"10.1056\/NEJM199912303412706","article-title":"Underrepresentation of patients 65 years of age or older in cancer-treatment trials","volume":"341","author":"Hutchins","year":"1999","journal-title":"N Engl J Med"},{"key":"2022041613311862900_ref4","doi-asserted-by":"crossref","first-page":"838","DOI":"10.1111\/bcp.13876","article-title":"Under-representation of elderly in clinical trials: an analysis of the initial approval documents in the Food and Drug Administration database","volume":"85","author":"Ruiter","year":"2019","journal-title":"Br J Clin Pharmacol"},{"key":"2022041613311862900_ref5","doi-asserted-by":"crossref","first-page":"1502","DOI":"10.1016\/j.ejca.2010.02.022","article-title":"EORTC elderly task force position paper: approach to the older cancer patient","volume":"46","author":"Pallis","year":"2010","journal-title":"Eur J Cancer"},{"key":"2022041613311862900_ref6","doi-asserted-by":"crossref","first-page":"392","DOI":"10.1200\/EDBK_201133","article-title":"Progress through collaboration: an ASCO and U.S. Food and Drug Administration workshop to improve the evidence base for treating older adults with cancer","volume":"38","author":"Singh","year":"2018","journal-title":"Am Soc Clin Oncol Educ Book"},{"key":"2022041613311862900_ref7","doi-asserted-by":"crossref","first-page":"e127","DOI":"10.14694\/EdBook_AM.2015.35.e127","article-title":"Geriatric oncology and clinical trials","volume":"35","author":"Lichtman","year":"2015","journal-title":"Am Soc Clin Oncol Educ Book"},{"key":"2022041613311862900_ref8","doi-asserted-by":"crossref","first-page":"3606s","DOI":"10.1158\/1078-0432.CCR-06-9007","article-title":"The cancer and leukemia group B cancer in the elderly committee: addressing a major cancer need","volume":"12","author":"Cohen","year":"2006","journal-title":"Clin Cancer Res"},{"key":"2022041613311862900_ref9","doi-asserted-by":"crossref","first-page":"196","DOI":"10.1016\/j.jgo.2018.12.008","article-title":"SIOG guidelines- essential for good clinical practice in geriatric oncology","volume":"10","author":"Dubianski","year":"2019","journal-title":"J Geriatr Oncol"},{"key":"2022041613311862900_ref10","doi-asserted-by":"crossref","first-page":"9113","DOI":"10.1200\/JCO.2005.03.7465","article-title":"Should elderly non-small-cell lung cancer patients be offered elderly-specific trials? Results of a pooled analysis from the north central cancer treatment group","volume":"23","author":"Jatoi","year":"2005","journal-title":"J Clin Oncol"},{"key":"2022041613311862900_ref11","doi-asserted-by":"crossref","first-page":"3711","DOI":"10.1200\/JCO.2013.49.6125","article-title":"End points and trial design in geriatric oncology research: a joint European organisation for research and treatment of cancer--alliance for clinical trials in oncology--international society of geriatric oncology position article","volume":"31","author":"Wildiers","year":"2013","journal-title":"J Clin Oncol"},{"key":"2022041613311862900_ref12","doi-asserted-by":"crossref","first-page":"852","DOI":"10.1056\/NEJMsa1012065","article-title":"The ClinicalTrials.gov results database--update and key issues","volume":"364","author":"Zarin","year":"2011","journal-title":"N Engl J Med"},{"key":"2022041613311862900_ref13","author":"US National Institutes of Health"},{"key":"2022041613311862900_ref14","doi-asserted-by":"crossref","first-page":"1029","DOI":"10.1007\/s11136-018-2076-0","article-title":"Assessing test-retest reliability of patient-reported outcome measures using intraclass correlation coefficients: recommendations for selecting and documenting the analytical formula","volume":"28","author":"Qin","year":"2019","journal-title":"Qual Life Res"},{"key":"2022041613311862900_ref15","doi-asserted-by":"crossref","first-page":"1799","DOI":"10.1093\/annonc\/mdw259","article-title":"Inclusion of elderly patients in oncology clinical trials","volume":"27","author":"Le Saux","year":"2016","journal-title":"Ann Oncol"},{"key":"2022041613311862900_ref16","doi-asserted-by":"crossref","first-page":"2606","DOI":"10.1093\/annonc\/mdx354","article-title":"Changes in the use of end points in clinical trials for elderly cancer patients over time","volume":"28","author":"Le Saux","year":"2017","journal-title":"Ann Oncol"},{"key":"2022041613311862900_ref17","doi-asserted-by":"crossref","first-page":"675","DOI":"10.1093\/annonc\/mdt592","article-title":"On-going clinical trials for elderly patients with a hematological malignancy: are we addressing the right end points?","volume":"25","author":"Hamaker","year":"2014","journal-title":"Ann Oncol"},{"key":"2022041613311862900_ref18","doi-asserted-by":"crossref","first-page":"1766","DOI":"10.1093\/jnci\/86.23.1766","article-title":"Age and clinical decision making in oncology patients","volume":"86","author":"Yellen","year":"1994","journal-title":"J Natl Cancer Inst"},{"key":"2022041613311862900_ref19","doi-asserted-by":"crossref","first-page":"545","DOI":"10.1007\/s10549-018-4865-0","article-title":"Patient-reported factors influencing the treatment decision-making process of older women with non-metastatic breast cancer: a systematic review of qualitative evidence","volume":"171","author":"Angarita","year":"2018","journal-title":"Breast Cancer Res Treat"},{"key":"2022041613311862900_ref20","doi-asserted-by":"crossref","first-page":"197","DOI":"10.1016\/j.ctrv.2014.12.010","article-title":"A systematic review of factors influencing older adults' decision to accept or decline cancer treatment","volume":"41","author":"Puts","year":"2015","journal-title":"Cancer Treat Rev"},{"key":"2022041613311862900_ref21","doi-asserted-by":"crossref","first-page":"1719","DOI":"10.1007\/s00432-019-02924-0","article-title":"Patient-reported outcomes and health-related quality of life for cetuximab versus bevacizumab in metastatic colorectal cancer: a prospective cohort study","volume":"145","author":"Marques","year":"2019","journal-title":"J Cancer Res Clin Oncol"},{"key":"2022041613311862900_ref22","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1186\/1477-7525-4-79","article-title":"Patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance","volume":"4","author":"Guidance for industry","year":"2006","journal-title":"Health Qual Life Outcomes"},{"key":"2022041613311862900_ref23","doi-asserted-by":"crossref","first-page":"379","DOI":"10.1001\/jamaoncol.2020.7478","article-title":"An analysis of contemporary oncology randomized clinical trials from low\/middle-income vs high-income countries","volume":"7","author":"Wells","year":"2021","journal-title":"JAMA Oncol"},{"key":"2022041613311862900_ref24","first-page":"972","article-title":"Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov. JAMA","volume":"173","author":"Hirsch","year":"2013","journal-title":"Intern Med"},{"key":"2022041613311862900_ref25","doi-asserted-by":"crossref","first-page":"265","DOI":"10.1007\/978-3-030-16391-4_11","article-title":"Artificial intelligence and personalized medicine","volume":"178","author":"Schork","year":"2019","journal-title":"Cancer Treat Res"},{"key":"2022041613311862900_ref26","doi-asserted-by":"crossref","first-page":"2718","DOI":"10.1016\/j.ejca.2015.07.045","article-title":"Clinical trial spots for cancer patients by tumour type: the cancer trials portfolio at ClinicalTrials.gov","volume":"51","author":"Prasad","year":"2015","journal-title":"Eur J Cancer"},{"key":"2022041613311862900_ref27","doi-asserted-by":"crossref","first-page":"e441","DOI":"10.1038\/bcj.2016.50","article-title":"Acute myeloid leukemia: a comprehensive review and 2016 update","volume":"6","author":"De Kouchkovsky","year":"2016","journal-title":"Blood Cancer J"},{"key":"2022041613311862900_ref28","doi-asserted-by":"crossref","first-page":"1838","DOI":"10.1001\/jama.2012.3424","article-title":"Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010","volume":"307","author":"Califf","year":"2012","journal-title":"JAMA"}],"container-title":["Age and Ageing"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ageing\/article-pdf\/51\/4\/afac087\/43379056\/afac087.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ageing\/article-pdf\/51\/4\/afac087\/43379056\/afac087.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,4,16]],"date-time":"2022-04-16T09:31:44Z","timestamp":1650101504000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ageing\/article\/doi\/10.1093\/ageing\/afac087\/6568538"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,4,1]]},"references-count":28,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2022,4,1]]}},"URL":"https:\/\/doi.org\/10.1093\/ageing\/afac087","relation":{"is-referenced-by":[{"id-type":"doi","id":"10.1007\/s12672-025-03790-8","asserted-by":"object"}]},"ISSN":["0002-0729","1468-2834"],"issn-type":[{"value":"0002-0729","type":"print"},{"value":"1468-2834","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2022,4]]},"published":{"date-parts":[[2022,4,1]]},"article-number":"afac087"}}