ClinicalTrials.gg
RecruitingNCT07703631Updated Jul 14, 2026

Characterization, Health Resource Utilization and Biomarkers in Early-stage

An observational study in Lung Cancer, sponsored by Hospital Universitario San Ignacio. Recruiting at 1 site in Colombia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Hospital Universitario San Ignacio · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
267
Ages
18 Years to 80 Years
Sex
All
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Study summary

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.

Read the 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 .
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Conditions studied

  • Lung Cancer

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Keywords

  • Biomarkers
  • Early-stage
  • Lung Cancer
  • Colombia
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In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 267 is above the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Hospital Universitario San Ignacio is the lead sponsor of 25 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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/ disease
  4. Patients diagnosed with resectable stage IA, IB, II, IIIA, and IIIB NSCLC in Colombia that went under immunotherapy treatment
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
267 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

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

Interventions

  • OtherMedical 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.

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What researchers measure

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

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Study locations

1 of 1 sites recruiting
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References and documents

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. PubMed 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. PubMed 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 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. PubMed 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-label, phase 3, randomised, controlled, non-inferiority trial. Lancet. 2022 Apr 23;399(10335):1607-1617. doi: 10.1016/S0140-6736(21)02333-3. PubMed 35461558 ↗

Individual participant data

Plan to share: No — 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

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07703631
Lead sponsor
Hospital Universitario San Ignacio
Responsible party
Sponsor
First posted
Jul 14, 2026
Start date
Jan 16, 2026
Primary completion
Sep 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 14, 2026

Study contacts

Raúl Murillo, Dr
Contact
rmurillo@husi.org.co
+57 (601) 5946161 ext. 5975
Raúl Murillo, Dr
principal investigator · Hospital Universitario San Ignacio

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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