Characterization, Health Resource Utilization and Biomarkers in Early-stage

ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHospital Universitario San Ignacio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients ≥ 18 years old

Patients diagnosed with NSCLC (stage IA, IB, II, IIIA, and IIIB)

Clinical records available

Patients with another primary tumor diagnosed (synchronic tumor)

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

267 Participants
are divided into 1 treatment group
Group A: subjects diagnosed with resectable stage1 intervention

Trial outcomes

Primary outcomes

1

patients with resectable stages

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)

Time frame
15 months
2

Time to diagnosis

from any pulmonary abnormality found by any diagnostic imaging to histopathology report in the participant institution

Time frame
15 months
3

Time to treatment

from histopathological diagnosis in the participant institution to first and subsequent courses of treatment (adjuvant/neoadjuvant chemotherapy, radiotherapy, or surgery) in the participant institution

Time frame
15 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Universitario San Ignacio

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator