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Characterization, Health Resource Utilization and Biomarkers in Early-stage

2026年7月8日 更新者:Hospital Universitario San Ignacio

Patient Journey, Clinical and Epidemiological Characterization, Health Resource Utilization and Biomarkers in Early-stage Lung Cancer in Colombia

Lung cancer is the leading cause of cancer incidence and mortality worldwide as it is for highand middle-income countries. A major decline in lung cancer incidence and mortality might be mainly due to the reduction on tobacco smoking prevalence since survival rates has not significantly improved despite the advances in diagnosis and treatment. Lung cancer is broadly classified into two categories, based on the type of tumor cells: small cell lung cancer and non-small cell lung cancer. Among them, is the most frequent type and is subdivided into histological types: Adenocarcinoma Squamous cell carcinoma of the lung arge cells carcinoma. Additional biological complexity has been uncovered through intense research in recent years, including different molecular subtypes with specific targetable characteristics. Diagnosing cancer at early stages (I or II) is critical as it may offer patients a better prognosis in terms of overall survival )for instance, patients diagnosed at stage IA have a 5- year survival rate higher than 80%, compared to less than 10% for those diagnosed at stage IV ostly because the possibility for most patients to undergo surgery or radiotherapy, as potentially curative interventions. A study among resectable lung cancer in Colombia found overall 3-year survival for patients with and without relapse 78% and 96%, respectively Early-stage may have a considerable recurrence rate despite of opportune and complete resections and the Colombian study found stage II (T3 and N1 as independent factors) and pleura invasion associated with a higher risk of recurrence.

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:

  1. contributory regimen based in a payroll system covering all individuals with payment capacity and their relatives
  2. 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

观察性的

注册 (估计的)

267

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Bogotá、哥伦比亚
        • 招聘中
        • Hospital Universitario San Ignacio

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The study sample will include patients ≥ 18 years old, newly diagnosed with resectable stage IA, IB, II, IIIA, and IIIB NSCLC from January 1st, 2017, to December 31st, 2023, in at least four healthcare institutions selected in Colombia. The ICD-10 code to identify the patients in the study will be from C33X to C3492 corresponding to lung cancer

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.

  1. Patients ≥ 18 years old
  2. Patients diagnosed with NSCLC (stage IA, IB, II, IIIA, and IIIB)
  3. Clinical records available

Exclusion Criteria:

  1. Patients with another primary tumor diagnosed (synchronic tumor)
  2. Patients from insurances regimens other than the public and private system.
  3. Patients with advanced/metastatic disease
  4. Patients diagnosed with resectable stage IA, IB, II, IIIA, and IIIB NSCLC in Colombia that went under immunotherapy treatment

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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
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.

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
patients with resectable stages
大体时间:15 months
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)
15 months
Time to diagnosis
大体时间:15 months
from any pulmonary abnormality found by any diagnostic imaging to histopathology report in the participant institution
15 months
Time to treatment
大体时间:15 months
from histopathological diagnosis in the participant institution to first and subsequent courses of treatment (adjuvant/neoadjuvant chemotherapy, radiotherapy, or surgery) in the participant institution
15 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月16日

初级完成 (估计的)

2026年9月1日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年7月8日

首先提交符合 QC 标准的

2026年7月8日

首次发布 (实际的)

2026年7月14日

研究记录更新

最后更新发布 (实际的)

2026年7月14日

上次提交的符合 QC 标准的更新

2026年7月8日

最后验证

2026年7月1日

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)?

不

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

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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