Clinical trial NCT01990651: Study of Use of CTC in NSCLC
Official title: The Use of Circulating Tumor Cells in Non-Small Cell Lung Cancer: Novel Isolation Methods and Clinical Applications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

For subjects with lung malignancies:

* 18 years of age and older
* Diagnosis of new or recurrent non-small cell lung cancer
* Awaiting treatment and follow up
* Have radiographic measurable metastatic disease that can be followed
* Be able to sign an IRB approved informed consent form
* Life expectancy greater than 12 weeks

For subjects with COPD and without lung malignancies:

* 18 years of age and older
* Diagnosis of COPD
* No current or prior malignancies (except squamous or basal cell carcinoma of the skin)
* Be able to sign an IRB approved informed consent form

For Healthy Control Subjects (Dry Runs):

* 18 years of age and older
* Has no current or prior malignancies (except squamous or basal cell carcinoma of the skin)
* Patients must sign an IRB approved informed consent form

Exclusion Criteria:

For subjects with lung malignancies:

* Have other concurrent lung cancer malignancies, or any other form of malignancy (except squamous or basal cell carcinoma of the skin)
* ECOG performance status of 4
* Pregnant female (self-reporting)
* Cognitively Impaired
* Prisoner

For subjects with COPD and without lung malignancies and Healthy Controls:

* Any other form of malignancy (except squamous or basal cell carcinoma of the skin)
* Pregnant female (self reporting)
* Cognitively impaired
* Prisoner

Primary outcomes:
measure: To estimate the correlation between the number of circulating tumor cells (CTC) and clinical stage of the disease
timeFrame: Completed within 6 months of the last sample collected
measure: 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
timeFrame: Measured up to 12 week post op
measure: To obtain preliminary data to assess whether lower numbers of CTC are associated with a reduction in tumor burden (by RECIST criteria) on imaging
timeFrame: Completed within 6 months of the last sample collected
measure: To obtain preliminary data to assess whether there is a decrease in the number of CTC during treatment with chemotherapy in Stage IV disease
timeFrame: measured up to completion of 4 cycles of chemo or up to 12 weeks after completion of radiation and chemo treatment
Secondary outcomes:
measure: To obtain preliminary data on the association of baseline number of CTC and disease-free survival for patients with all stages of disease
timeFrame: Will be assessed for up to 2 years after subjects last visit
measure: To obtain preliminary data on the association of baseline number of CTC and overall survival for patients with all stages of disease
timeFrame: Will be assessed for up to 2 years after subjects last visit
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia Health System
name: Thao Dang, MD
role: PRINCIPAL_INVESTIGATOR
References: