An observational study in Non Small Cell Lung Cancer and Chronic Obstructive Pulmonary Disease, sponsored by University of Virginia. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-21.
Sponsored by University of Virginia · Observational
The purpose of this study is to assess whether the detection of circulating tumor cells (CTC) could be used as a tool to earlier diagnose, more accurately predict treatment response / failure and predict overall survival in non-small cell lung cancer (NSCLC) patients
Lung cancer remains the most common cause of cancer mortality in the world for both men and women. More than half of patients diagnosed will die within the first year. Given these concerning facts, we are in need of novel methodologies to diagnose patients at earlier stages of the disease, more accurately predict treatment response / failure and predict overall survival.
The use of CTC has been investigated and shown to predict progression free survival and overall survival in metastatic breast cancer, and recommended as a breast cancer tumor marker by the American Society of Clinical Oncology. There have also been relationships between CTC's and survival, shown in metastatic colorectal and prostate cancer. However, CTC's have not been thoroughly investigated in non-small cell lung cancer. This trial will assess if the detection of circulating tumor cells could be used as a tool to help further advance treatment for NSCLC patients.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 30 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
primary care clinic
For subjects with lung malignancies:
For subjects with COPD and without lung malignancies:
For Healthy Control Subjects (Dry Runs):
Exclusion Criteria:
For subjects with lung malignancies:
For subjects with COPD and without lung malignancies and Healthy Controls:
To estimate the correlation between the number of circulating tumor cells (CTC) and clinical stage of the disease
Time frame: Completed within 6 months of the last sample collected
In Stage I, II or III patients with resectable disease, to obtain preliminary data to assess whether the number of CTC in post operative peripheral blood samples decrease compared with the number of CTC in the pre operative peripheral blood samples
Time frame: Measured up to 12 week post op
To obtain preliminary data to assess whether lower numbers of CTC are associated with a reduction in tumor burden (by RECIST criteria) on imaging
Time frame: Completed within 6 months of the last sample collected
To obtain preliminary data to assess whether there is a decrease in the number of CTC during treatment with chemotherapy in Stage IV disease
Time frame: measured up to completion of 4 cycles of chemo or up to 12 weeks after completion of radiation and chemo treatment
To obtain preliminary data on the association of baseline number of CTC and disease-free survival for patients with all stages of disease
Time frame: Will be assessed for up to 2 years after subjects last visit
To obtain preliminary data on the association of baseline number of CTC and overall survival for patients with all stages of disease
Time frame: Will be assessed for up to 2 years after subjects last visit
This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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University of Virginia