Characterization, Health Resource Utilization and Biomarkers in Early-stage

Official title

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

Overview

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.

Detailed description

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 .

Interventions

• Other Medical chart review will be performed in patients with resectable stage
  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-

Primary outcome measures

• patients with resectable stages [Time frame: 15 months]
• Time to diagnosis [Time frame: 15 months]
• Time to treatment [Time frame: 15 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Colombia · 1 center

• Hospital Universitario San Ignacio — Bogotá

Publications

• 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. PMID 38572751
• 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. PMID 36452118
• 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 In PMID 26762738
• 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- PMID 35461558

Identifiers

NCT: NCT07703631 · 2025/010

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗