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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Nebraska
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT01173458
First received: July 27, 2010
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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
Small Cell Lung Cancer

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 25
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Eligible patients will be approached during their regularly scheduled Cancer Center appointments.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173458

Locations
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
University of Nebraska
Investigators
Principal Investigator: Chao H Huang, MD, FACP University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT01173458     History of Changes
Other Study ID Numbers: 12216
Study First Received: July 27, 2010
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
cancer
lung
small cell

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

ClinicalTrials.gov processed this record on August 28, 2014