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Trial Title:
Biomarker Discovery and Validation in Lung Cancer
NCT ID:
NCT01147562
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Lung cancer
Biopsy
Biomarker
Tissue Collection
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Collection of biospecimen
Description:
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.
Arm group label:
Lung Cancer Patients
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier de Luxembourg (CHL)
Address:
City:
Luxembourg
Zip:
1210
Country:
Luxembourg
Facility:
Name:
Clinique Sainte Thérèse (Zithaklinik)
Address:
City:
Luxembourg
Zip:
L-2763
Country:
Luxembourg
Start date:
October 14, 2009
Completion date:
October 2020
Lead sponsor:
Agency:
Dr. Guy Berchem
Agency class:
Other
Collaborator:
Agency:
Integrated Biobank of Luxembourg
Agency class:
Other
Collaborator:
Agency:
Centre Hospitalier du Luxembourg
Agency class:
Other
Source:
Public Research Centre Health, Luxembourg
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01147562