Characterization, Health Resource Utilization and Biomarkers in Early-stage
Patient Journey, Clinical and Epidemiological Characterization, Health Resource Utilization and Biomarkers in Early-stage Lung Cancer in Colombia
研究概览
详细说明
Cancer is a high-cost disease that generates an important economic impact on healthcare systems. It is possible that system fragmentation can potentially be associated to poorer outcomes for these patients. Colombia has an individual insurance-based system with two affiliation regimes:
- contributory regimen based in a payroll system covering all individuals with payment capacity and their relatives
- subsidized regimen aimed at individuals without payment capacity. Currently, the insurance coverage is over 99% in the country. The insurance is publicly funded but administered by health insurance companies, most of them private. There is freedom of choice for the insurer, but the health insurance companies define the network of health care providers for their affiliates. Available data indicates significant disparities in lung cancer mortality by socioeconomic condition in Colombia . In addition, a recent report shows that lung cancer imposes a significant economic burden on the Colombian health system and the reported costs of lung cancer care are lower in the subsidized regimen, suggesting relevant differences in patterns of cancer care between insurance regimes despite all patients are entitled to a unique health benefit package Furthermore, some reports show how the fragmentation of cancer care even within the same affiliation regimen is frequent in Colombia having effect on timeliness and quality of medical care and leading to poor health outcomes and the need of additional lines of treatment with associated higher cost as in the case of cancer care. Indeed, it has been demonstrated that early detection efforts and screening campaigns can have a positive pharmacoeconomic effect, mostly in association with the possibility to offer potentially curative interventions. Furthermore, integrated management of patients leads to improved overall survival However, we currently do not have local data to eventually support health system interventions around these measures, particularly in Early-Stages .
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Raúl Murillo, Dr
- 电话号码:5975 +57 (601) 5946161
- 邮箱:rmurillo@husi.org.co
学习地点
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Bogotá、哥伦比亚
- 招聘中
- Hospital Universitario San Ignacio
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
All inclusion and exclusion criteria will be reviewed by the investigator or qualified designee to ensure that the subject qualifies for the study.
- Patients ≥ 18 years old
- Patients diagnosed with NSCLC (stage IA, IB, II, IIIA, and IIIB)
- Clinical records available
Exclusion Criteria:
- Patients with another primary tumor diagnosed (synchronic tumor)
- Patients from insurances regimens other than the public and private system.
- Patients with advanced/metastatic disease
- Patients diagnosed with resectable stage IA, IB, II, IIIA, and IIIB NSCLC in Colombia that went under immunotherapy treatment
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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subjects diagnosed with resectable stage
To identify the patient journey of subjects diagnosed with resectable stage IA, IB, II, IIIA, and IIIB Non-small Cell Lung Cancer in Colombia
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The study will focus on patients with a new diagnosis of resectable stage IA, IB, II, IIIA, and IIIB non-small cell lung cancer diagnosed between January 2017 and December 2023.
Data collection will be organized into three specific time periods: first, the index period, which will consist of confirmed diagnosis patients from January 2017 to December 2023; second, the prediagnosis period, defined as 18 months prior to the index period, this is from July 2015 to January 2017; and lastly, a follow-up period that will allow a minimum duration of six months.
As a result, the data cutoff date for this study will be set for June 2024.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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patients with resectable stages
大体时间:15 months
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Proportion of patients with resectable stages of NSCLC that were detected by Health System Regime (Contributive vs Subsidized), and distribution across clinical stage (IA, IB, II, IIIA, and IIIB NSCLC)
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15 months
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Time to diagnosis
大体时间:15 months
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from any pulmonary abnormality found by any diagnostic imaging to histopathology report in the participant institution
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15 months
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Time to treatment
大体时间:15 months
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from histopathological diagnosis in the participant institution to first and subsequent courses of treatment (adjuvant/neoadjuvant chemotherapy, radiotherapy, or surgery) in the participant institution
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15 months
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合作者和调查者
调查人员
- 首席研究员:Raúl Murillo, Dr、Hospital Universitario San Ignacio
出版物和有用的链接
一般刊物
- Goldstraw P, Chansky K, Crowley J, Rami-Porta R, Asamura H, Eberhardt WE, Nicholson AG, Groome P, Mitchell A, Bolejack V; International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee, Advisory Boards, and Participating Institutions; International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee Advisory Boards and Participating Institutions. The IASLC Lung Cancer Staging Project: Proposals for Revision of the TNM Stage Groupings in the Forthcoming (Eighth) Edition of the TNM Classification for Lung Cancer. J Thorac Oncol. 2016 Jan;11(1):39-51. doi: 10.1016/j.jtho.2015.09.009.
- Saji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, Aoki T, Okami J, Yoshino I, Ito H, Okumura N, Yamaguchi M, Ikeda N, Wakabayashi M, Nakamura K, Fukuda H, Nakamura S, Mitsudomi T, Watanabe SI, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial. Lancet. 2022 Apr 23;399(10335):1607-1617. doi: 10.1016/S0140-6736(21)02333-3.
- Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- Bravo LE, Garcia LS, Collazos P, Holguin J, Soerjomataram I, Miranda-Filho A. Trends in long-term cancer survival in Cali, Colombia: 1998-2017. Colomb Med (Cali). 2022 Mar 30;53(1):e2035082. doi: 10.25100/cm.v53i1.5082. eCollection 2022 Jan-Mar.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
By signing this protocol, the investigator recognizes that certain personal identifying information with respect to the investigator, and all subinvestigators and study site personnel may be used and disclosed for study management purposes, as part of a regulatory submissions, and as required by law. This information may include:
- name, address, telephone number and e-mail address;
- hospital or clinic address and telephone number;
- curriculum vitae or other summary of qualifications and credentials; and
- other professional documentation
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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