Circulating Tumor Cells (CTCs) as a Blood-based Tumor Marker in Patients With Small Cell Lung Cancer (SCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01173458
Recruitment Status : Completed
First Posted : August 2, 2010
Last Update Posted : January 10, 2017
VA Office of Research and Development
University of Nebraska
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
The purpose of this study is to determine whether or not CTCs can be detected in blood samples taken from patients diagnosed with small cell lung cancer. The purpose is to compare CTC analysis to tumor samples to look for differences.

Condition or disease
Small Cell Lung Cancer

Detailed Description:

Small cell lung cancer (SCLC) is characterized by early dissemination through the blood system with the majority of patients succumbing to their disease in 9-11 months. Despite evaluation of multiple new agents a platinum doublet has remained the standard of care for over 25 years. We believe that the lack of understanding of the biology of SCLC has contributed to our failure to advance treatment and prolong survival. Tumor and blood biomarkers have been shown to be a powerful tool for increasing our understanding of the complex biology of cancer and determining prognosis and response to therapies. Currently, there are no validated biomarkers for response or to follow disease activity in SCLC. Detection of Circulating Tumor Cells (CTCs) is a laboratory technique that became available in the last few decades. Newer, more sensitive technology for the isolation and characterization of CTCs using a rare event imaging system with automated fluorescence microscopy known as CellSearch has demonstrated value in several cancers. CTCs detection by this system is approved as a prognostic biomarker in metastatic breast cancer, and as a tool to monitor disease in metastatic colorectal cancer and castrate resistant prostate cancer.

To date, only one publication has reported on the presence of CTCs in SCLC. These investigators used RT-PCR to amplify CK19 cDNA. CTCs were detected in 27% of patients. In our preliminary study using the CellSearch system we have detected 1 or more CTCs in 11/13 (84%) patient samples in various stages of their disease. Thus CTCs may be a promising biomarker but we need more studies. Thus, our first goal is to determine if CTCs in SCLC can predict response to chemotherapy, predict early relapse or function as a as a prognostic marker.

In addition, we will explore the feasibility of extracting genetic material from CTCs for genomic profile that could immensely help us unravel the complex molecular pathways and gene expression in SCLC, which ultimately will lead to novel drug development. Other investigators have shown that gene expression profiles for CTCs may be used to distinguish normal donor from advanced cancer patients and differentiate among different types of cancers.

In summary, SCLC kills 45,000 Americans each year. The treatment of SCLC has not changed since the introduction of cisplatin and etoposide during 1970s. Research in cancer biology has identified several genetic alterations that could be of therapeutic importance. Novel agents that target these genetic alterations are currently in development. Patient selection will be key in order to determine the activity of these agents. Understanding the biology of this disease is the key to successful interventions and personalizing therapy.

Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicenter Pilot Study Examining the Role of Circulating Tumor Cells (CTCs) as a Blood-based Tumor Marker in Patients With Small Cell Lung Cancer (SCLC)
Study Start Date : July 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Blood Draw

Approximately 1 and one-half teaspoons of blood will be drawn at times specified.

  • one sample prior to treatment initiation
  • one sample after completion of treatment
  • one sample every 6 to 8 weeks during follow up visits
  • one sample at the time of Relapse

Primary Outcome Measures :
  1. Subject samples will be used to determine the correlation between CTCs in SCLC patients, detected by CellSearch, with treatment outcomes, including response to chemotherapy, relapse, and survival [ Time Frame: average 2 years ]

Secondary Outcome Measures :
  1. Blood samples will be used to examine the genomic profiles of CTCs and compare them to the original tumor specimen. [ Time Frame: average 2 years ]

Biospecimen Retention:   Samples With DNA
Blood samples will be collected before treatment begins, at completion of treatment, and every 6 to 8 weeks during follow-up visits.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Eligible patients will be approached during their regularly scheduled Cancer Center appointments.

Inclusion Criteria:

  • Histological proof of small cell lung cancer with extensive stage disease and have been untreated.
  • Must be willing to give and sign informed consent.
  • Must be 18 years of age

Exclusion Criteria:

  • Less than 18 years of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01173458

United States, Kansas
University of Kansas Medical Centner
Kansas City, Kansas, United States, 66160
United States, Nebraska
University of Nebraska & Omaha VA
Omaha, Nebraska, United States, 68105
Sponsors and Collaborators
University of Kansas Medical Center
VA Office of Research and Development
University of Nebraska
Principal Investigator: Chao H Huang, MD, FACP University of Kansas Medical Center

Responsible Party: University of Kansas Medical Center Identifier: NCT01173458     History of Changes
Other Study ID Numbers: 12216
First Posted: August 2, 2010    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017

Keywords provided by University of Kansas Medical Center:
small cell

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Neoplastic Cells, Circulating
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes