Biomarker Discovery and Validation in Lung Cancer (LCS)

This study is currently recruiting participants.
Verified May 2011 by Public Research Centre Health, Luxembourg
Sponsor:
Information provided by:
Public Research Centre Health, Luxembourg
ClinicalTrials.gov Identifier:
NCT01147562
First received: June 17, 2010
Last updated: May 9, 2011
Last verified: May 2011

June 17, 2010
May 9, 2011
October 2009
October 2014   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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.
Discover and validate molecular biomarkers for lung cancer [ Time Frame: Baseline (blood and/or tissue) and Follow-up (only blood) every 6 months (or in case of change in chemotherapy) up to 5 years ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01147562 on ClinicalTrials.gov Archive Site
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Biomarker Discovery and Validation in Lung Cancer
Biomarker Discovery and Validation in Lung Cancer

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Lung Cancer
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.
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
Intervention: Procedure: Collection of biospecimen

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
October 2019
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Guy Berchem, MD +352-44 112084 berchem.guy@chl.lu
Luxembourg
 
NCT01147562
IBBL0001
No
Guy Berchem, MD, Centre Hospitalier du Luxembourg
Public Research Centre Health, Luxembourg
Not Provided
Not Provided
Public Research Centre Health, Luxembourg
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP