Study of Use of CTC in NSCLC

The Use of Circulating Tumor Cells in Non-Small Cell Lung Cancer: Novel Isolation Methods and Clinical Applications

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

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease; Non Small Cell Lung Cancer

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia Health System
      • Contact: Royanne Dell; Phone Number: 434-924-9496; Email: RLB8Y@virginia.ed
      • Principal Investigator: Thao Dang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To estimate the correlation between the number of circulating tumor cells (CTC) and clinical stage of the disease	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	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	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	measured up to completion of 4 cycles of chemo or up to 12 weeks after completion of radiation and chemo treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
To obtain preliminary data on the association of baseline number of CTC and disease-free survival for patients with all stages of disease	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	Will be assessed for up to 2 years after subjects last visit

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Thao Dang, MD, University of Virginia Health System

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: November 15, 2013
• First Submitted That Met QC Criteria: November 15, 2013
• First Posted (Estimate): November 21, 2013

Study Record Updates

• Last Update Posted (Estimate): November 21, 2013
• Last Update Submitted That Met QC Criteria: November 15, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 15847