Clinical and Molecular Staging of Lung Cancer Stages I and IIp

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03286036
• Other study ID #: PI12/02040
• Status: Active, not recruiting
• Start date: January 1, 2013
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2019
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• over 18 years old

• Able to understand and sign the informed consent

Exclusion Criteria:

• Absence of mediastinal disease

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• biomarkers
This is an observational study, there is no intervention

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Son Espases	Palma de Mallorca	Islas Baleares
Spain	Hospital Virgen del Rocio	Sevilla

Sponsors (3)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Consorcio Centro de Investigación Biomédica en Red, M.P., Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Monsó E, Montuenga LM, Sánchez de Cos J, Villena C; Lung Cancer CIBERES-RTICC-SEPAR-Plataforma Biobanco Pulmonar. Biological Marker Analysis as Part of the CIBERES-RTIC Cancer-SEPAR Strategic Project on Lung Cancer. Arch Bronconeumol. 2015 Sep;51(9):462-7. doi: 10.1016/j.arbres.2014.11.010. Epub 2015 Jan 19. English, Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort creation	Prospective cohort with detailed information of the clinical characteristics at the time of surgery and with biological samples	6 years
Secondary	Biological markers	To identify biological variables with potential prognostic and / or predictive capacity of the therapeutic response, independent of the pathological TNM, in biological samples	3 years