Biomarker Discovery and Validation in Lung Cancer (LCS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01147562|
Recruitment Status : Active, not recruiting
First Posted : June 22, 2010
Last Update Posted : February 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Procedure: Collection of biospecimen||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biomarker Discovery and Validation in Lung Cancer|
|Actual Study Start Date :||October 14, 2009|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||October 2020|
Lung Cancer Patients
Patients with a suspected or confirmed diagnosis of lung cancer, whether or not scheduled for lesion biopsy, thoracentesis or surgical resection of their tumor
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.
- Discover and validate molecular biomarkers for lung cancer [ Time Frame: Participants are followed up very 6 months up to to 5 years or until death. ]Investigate markers capable of prediciting response to chemotherapy. In cas a pulmonary nodule is diagnosed and has to be characterized, a biomarker could predict whether the nodule is or is not cancerous and thus, make CT Scan follow up unnecessary.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01147562
|Centre Hospitalier de Luxembourg (CHL)|
|Luxembourg, Luxembourg, 1210|
|Clinique Sainte Thérèse (Zithaklinik)|
|Luxembourg, Luxembourg, L-2763|
|Principal Investigator:||Guy Berchem, MD||Centre Hospitalier du Luxembourg|