Search for more clinical trials
Biomarker Discovery and Validation in Lung Cancer
Conditions
Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
Lung cancer, Biopsy, Biomarker, Tissue Collection
Study Type
Interventional
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label
Intervention
Name: Collection of biospecimen
Type: Procedure
Overall Status
Recruiting
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.
Detailed Description
The primary objective of this study is to discover and validate molecular biomarkers for lung cancer.
Lung cancer remains the leading cause of cancer death in industrialized countries. Most patients with non-small cell lung cancer (NSCLC) present with advanced disease, and despite recent advances in multi-modality therapy, the overall 10-year survival rate is less than 10%. A significant minority of patients (25−30%) with NSCLC have stage I disease and receive surgical intervention alone. Although 35−50% of patients with stage I disease will relapse within 5 years, it is not currently possible to identify specific high-risk patients. In addition, for patients with metastatic disease, standard chemotherapeutic approaches result in less than 50% response rate, meaning that more than half of patients do not benefit and only suffer from side effects.
Only very limited data exists on markers capable of predicting response to chemotherapy.
This population would certainly also benefit from more of those markers. Another situation where a biomarker could be potentially very useful is the situation where a pulmonary nodule is diagnosed and has to be characterized. In this situation a biomarker could predict whether the nodule is or is not cancerous and thus, make CT Scan follow up unnecessary.
Lung cancer remains the leading cause of cancer death in industrialized countries. Most patients with non-small cell lung cancer (NSCLC) present with advanced disease, and despite recent advances in multi-modality therapy, the overall 10-year survival rate is less than 10%. A significant minority of patients (25−30%) with NSCLC have stage I disease and receive surgical intervention alone. Although 35−50% of patients with stage I disease will relapse within 5 years, it is not currently possible to identify specific high-risk patients. In addition, for patients with metastatic disease, standard chemotherapeutic approaches result in less than 50% response rate, meaning that more than half of patients do not benefit and only suffer from side effects.
Only very limited data exists on markers capable of predicting response to chemotherapy.
This population would certainly also benefit from more of those markers. Another situation where a biomarker could be potentially very useful is the situation where a pulmonary nodule is diagnosed and has to be characterized. In this situation a biomarker could predict whether the nodule is or is not cancerous and thus, make CT Scan follow up unnecessary.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- Patients with a suspected or confirmed diagnosis of lung cancer, whether or not scheduled for lesion biopsy, thoracentesis or surgical resection of their tumor
Exclusion Criteria:
- Pregnant women
- Minors (subjects less than 18 years of age)
- Prisoners
- Subjects unable to consent for themselves
- Patients with a suspected or confirmed diagnosis of lung cancer, whether or not scheduled for lesion biopsy, thoracentesis or surgical resection of their tumor
Exclusion Criteria:
- Pregnant women
- Minors (subjects less than 18 years of age)
- Prisoners
- Subjects unable to consent for themselves
Locations
Centre Hospitalier de Luxembourg (CHL)
Luxembourg, Luxembourg
Clinique Sainte Thérèse (Zithaklinik)
Status: Recruiting
Contact: Guy Berchem - +352-44 111-1 - berchem.guy@chl.lu
Luxembourg, Luxembourg
Status: Recruiting
Contact: Georges Decker, MD
Start Date
October 2009
Completion Date
October 2019
Sponsors
Dr. Guy Berchem
Source
Public Research Centre Health, Luxembourg
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page