Clinical and Molecular Staging of Lung Cancer Stages I and IIp

NCT ID: NCT03286036

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-01
• Study Completion Date: 2020-12-31

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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Lung cancer patients

Patients with lung cancer who undergo surgical resection of the tumor

biomarkers

Intervention Type: OTHER

This is an observational study, there is no intervention

Interventions

biomarkers

This is an observational study, there is no intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Absence of mediastinal disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Consorcio Centro de Investigación Biomédica en Red (CIBER)

OTHER_GOV

Sponsor Role: collaborator

Corporacion Parc Tauli

OTHER

Sponsor Role: lead

Responsible Party

Eduard Monsó-Molas

Head of Respiratory Medicine Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital del Mar

Barcelona, , Spain

Hospital Virgen del Rocio

Seville, , Spain

Countries

Spain

References

Monso E, Montuenga LM, Sanchez 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.

Reference Type: BACKGROUND

PMID: 25614375 (View on PubMed)

Other Identifiers

PI12/02040

Identifier Type: -

Identifier Source: org_study_id