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Clinical and Molecular Staging of Lung Cancer Stages I and IIp

Clinical and Molecular Staging of Lung Cancer Stages I and IIp: Generation and Initial Analysis of a Clinical and Molecular Knowledge Database

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03286036
Enrollment
200
Registered
2017-09-18
Start date
2013-01-01
Completion date
2020-12-31
Last updated
2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Biomarkers, early detection

Brief summary

The classification of lung cancer (LC) according to the degree of anatomical extension (TNM) allows the estimation of the prognosis of the patient, although its accuracy is limited. In fact, one third of surgically-treated patients with initial disease have recurrences during follow-up, despite the negativity of node dissection at surgery. The incorporation of genetic, epigenetic and proteomic information to TNM staging will characterize more accurately the lung cancer, and thereby improve the prognostic and the prediction of the therapeutic response in these patients.In this project a prospective cohort of 320 patients with lung cancer staged I-IIp will be studied, combining the clinical and pathologic information available with genetic, epigenetic and proteomic markers in tumour samples, pulmonary tissue, regional nodes and peripheral blood, preserved in suitable systems for the application of complex analytical methodologies. Thus, a knowledge database will be created with the aim of improving the prognostic and prediction capabilities of TNM staging.This project is coordinated with related sub-projects that cover the required laboratory tests on biological samples and with Spanish collaborative group in lung cancer.

Interventions

OTHERbiomarkers

This is an observational study, there is no intervention

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Consorcio Centro de Investigación Biomédica en Red (CIBER)
CollaboratorOTHER_GOV
Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

Inclusion criteria

* over 18 years old * Able to understand and sign the informed consent

Exclusion criteria

* Absence of mediastinal disease

Design outcomes

Primary

MeasureTime frameDescription
Cohort creation6 yearsProspective cohort with detailed information of the clinical characteristics at the time of surgery and with biological samples

Secondary

MeasureTime frameDescription
Biological markers3 yearsTo identify biological variables with potential prognostic and / or predictive capacity of the therapeutic response, independent of the pathological TNM, in biological samples

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026