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Characterization, Health Resource Utilization and Biomarkers in Early-stage

8 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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 .

Studietype

Observationeel

Inschrijving (Geschat)

267

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Colombia
      • Bogotá, Colombia
        • Werving
        • Hospital Universitario San Ignacio

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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
Ander: 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-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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
patients with resectable stages
Tijdsspanne: 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
Tijdsspanne: 15 months
from any pulmonary abnormality found by any diagnostic imaging to histopathology report in the participant institution
15 months
Time to treatment
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospital Universitario San Ignacio

Medewerkers

Merck Sharp & Dohme LLC

Onderzoekers

  • Hoofdonderzoeker: Raúl Murillo, Dr, Hospital Universitario San Ignacio

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

16 januari 2026

Primaire voltooiing (Geschat)

1 september 2026

Studie voltooiing (Geschat)

31 december 2026

Studieregistratiedata

Eerst ingediend

8 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 juli 2026

Eerst geplaatst (Werkelijk)

14 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

8 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2025/010

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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