Study of Use of CTC in NSCLC

NCT ID: NCT01990651

Last Updated: 2013-11-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30

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.

Conditions

Non Small Cell Lung Cancer; Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thao Dang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Health System

Locations

University of Virginia Health System

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Royanne Dell

Role: CONTACT

RLB8Y@virginia.edu

434-924-9496

Snjezana Zaja-Milatovic

Role: CONTACT

sz7s@virginia.edu

434-243-6575

Facility Contacts

Royanne Dell

Role: primary

RLB8Y@virginia.ed

434-924-9496

Other Identifiers

15847

Identifier Type: -

Identifier Source: org_study_id