NCT03286036

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

8 years

First QC Date

September 14, 2017

Last Update Submit

February 12, 2019

Conditions

Lung Cancer

Keywords

Biomarkers, early detection

Outcome Measures

Primary Outcomes (1)

  • Cohort creation

    Prospective cohort with detailed information of the clinical characteristics at the time of surgery and with biological samples

    6 years

Secondary Outcomes (1)

  • Biological markers

    3 years

Study Arms (1)

Lung cancer patients

Patients with lung cancer who undergo surgical resection of the tumor

Other: biomarkers

Interventions

biomarkersOTHER

This is an observational study, there is no intervention

Lung cancer patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Lung cancer patients who undergo surgical resection of their tumors in a Spanish hospital with thoracic surgery and pathological anatomy departments

You may qualify if:

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

You may not qualify if:

  • Absence of mediastinal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Son Espases

Palma de Mallorca, Balearic Islands, 07010, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Virgen del Rocio

Seville, 41013, Spain

Location

Related Publications (1)

  • 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.

    PMID: 25614375BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

tumoral tissue, non-tumoral tissue and blood samples

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Factors

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Respiratory Medicine Department

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 18, 2017

Study Start

January 1, 2013

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

This is a multicenter study and the patients' samples and clinical data will be available to the study collaborators when the recruitment finishes.

Locations

ES(4)