Clinical and Molecular Staging of Lung Cancer Stages I and IIp

• Conditions: Lung Cancer
• Interventions: Other: biomarkers

• Registration Number: NCT03286036
• Lead Sponsor: Corporacion Parc Tauli

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-01
• Study First Submitted: 2017-09-14
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-18
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• Absence of mediastinal disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung cancer patients	biomarkers	Patients with lung cancer who undergo surgical resection of the tumor

Primary Outcome Measures

Name	Time	Method
Cohort creation	6 years	Prospective cohort with detailed information of the clinical characteristics at the time of surgery and with biological samples

Secondary Outcome Measures

Name	Time	Method
Biological markers	3 years	To identify biological variables with potential prognostic and / or predictive capacity of the therapeutic response, independent of the pathological TNM, in biological samples

Trial Locations

Locations (4)

Hospital Virgen del Rocio; 🇪🇸 Sevilla, Spain

Hospital Son Espases; 🇪🇸 Palma de Mallorca, Islas Baleares, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain