Characterization, Health Resource Utilization and Biomarkers in Early-stage
8 lipca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Warunki
Interwencja / Leczenie
Szczegółowy opis
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:
- contributory regimen based in a payroll system covering all individuals with payment capacity and their relatives
- 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 .
Typ studiów
Obserwacyjny
Zapisy (Szacowany)
267
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Raúl Murillo, Dr
- Numer telefonu: 5975 +57 (601) 5946161
- E-mail: rmurillo@husi.org.co
Lokalizacje studiów
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Bogotá, Kolumbia
- Rekrutacyjny
- Hospital Universitario San Ignacio
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
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
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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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
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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patients with resectable stages
Ramy czasowe: 15 months
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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)
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15 months
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Time to diagnosis
Ramy czasowe: 15 months
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from any pulmonary abnormality found by any diagnostic imaging to histopathology report in the participant institution
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15 months
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Time to treatment
Ramy czasowe: 15 months
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from histopathological diagnosis in the participant institution to first and subsequent courses of treatment (adjuvant/neoadjuvant chemotherapy, radiotherapy, or surgery) in the participant institution
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15 months
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Raúl Murillo, Dr, Hospital Universitario San Ignacio
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
- 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.
- 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.
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
16 stycznia 2026
Zakończenie podstawowe (Szacowany)
1 września 2026
Ukończenie studiów (Szacowany)
31 grudnia 2026
Daty rejestracji na studia
Pierwszy przesłany
8 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
8 lipca 2026
Pierwszy wysłany (Rzeczywisty)
14 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
14 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
8 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2025/010
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
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
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .