- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01147562
Biomarker Discovery and Validation in Lung Cancer (LCS)
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Luxembourg, Luxembourg, 1210
- Centre Hospitalier de Luxembourg (CHL)
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Luxembourg, Luxembourg, L-2763
- Clinique Sainte Thérèse (Zithaklinik)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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Participants are followed up very 6 months up to to 5 years or until death.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guy Berchem, MD, Centre Hospitalier du Luxembourg
Publications and helpful links
General Publications
- Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.
- Dziadziuszko R, Hirsch FR. Advances in genomic and proteomic studies of non-small-cell lung cancer: clinical and translational research perspective. Clin Lung Cancer. 2008 Mar;9(2):78-84. doi: 10.3816/CLC.2008.n.012.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBBL0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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