Biomarker Discovery and Validation in Lung Cancer

Summary

Lung cancer is responsible for the most deaths due to cancer each year in both men and women worldwide and once diagnosed, the 10 year survival rate is poor (\<15%). This poor prognosis is based in large part on the absence of an effective diagnostic test for the disease. The chief objective of this study is to develop a molecular-based diagnostic test specific for lung cancer. Subjects suspected or diagnosed with lung cancers, who are either undergoing thoracentesis, biopsy of a suspicious lesion or surgical resection of their tumor will be asked to participate in this study. Those subjects, who will undergo surgical resection, will donate both lung tumor tissue and adjacent normal lung tissue (potentially including lymph nodes), while non-surgical candidates will donate a portion of their excess biopsy sample, if available, after diagnosis has been confirmed. Subjects undergoing thoracentesis for pleural effusion will donate a portion of their fluid sample, if the fluid volume collected is in excess of that needed for clinical care purposes. Blood samples and optionally saliva will also be collected from all subjects, whether undergoing surgery or not. In addition to biosample collection, detailed annotated demographic and clinical information will be collected from subjects. Subjects will be followed for outcome analysis, specifically for tumor recurrence, every 6 months, during 5 years. In case of change in chemotherapy treatment, biosamples and clinical information will also be collected. Collected biosamples will be analyzed using a series of molecular and proteomic technologies for developing biomarkers of the disease.

Conditions

• Lung Cancer

Interventions

PROCEDURE

Collection of biospecimen

Collection of saliva, blood and tissues from subjects diagnosed with lung cancer, who are scheduled for biopsy of their lesion or surgical resection of their tumor.

Sponsors & Collaborators

• Integrated Biobank of Luxembourg

  collaborator OTHER

• Centre Hospitalier du Luxembourg

  collaborator OTHER

• Dr. Guy Berchem

  lead OTHER

Principal Investigators

• Guy Berchem, MD · Centre Hospitalier du Luxembourg

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-14

Primary Completion

2020-07-31

Completion

2020-10-31

Countries

• Luxembourg

Study Locations