Small Cell Lung CancerNCT01173458
Circulating Tumor Cells (CTCs) as a Blood-based Tumor Marker in Patients With Small Cell Lung Cancer (SCLC)
An observational study of Small Cell Lung Cancer, run by University of Kansas Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2010to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients will be approached during their regularly scheduled Cancer Center appointments.
Who may be able to join
- 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
Who cannot join
- Less than 18 years of age.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Medical Centner
Kansas City, Kansas, 66160
University of Nebraska & Omaha VA
Omaha, Nebraska, 68105
About this study
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)
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.
Read the 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.
- Conditions
- Small Cell Lung Cancer
- Keywords
- cancer, lung, small cell
- Medical subject headings
- Small Cell Lung Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: average 2 years
Secondary outcomes (1)
Blood samples will be used to examine the genomic profiles of CTCs and compare them to the original tumor specimen.
Measured: average 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2012
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development, University of Nebraska
- Responsible party
- Sponsor
- Investigators
- Chao H Huang, MD, FACP, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173458
- Sponsor's protocol ID
- 12216
- Status last verified
- Jan 2017
- First submitted
- 27 Jul 2010
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01173458
- Acronym / sponsor ID
- 12216
- Conditions
- Small Cell Lung Cancer
- Keywords
- cancer, lung, small cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- VA Office of Research and Development, University of Nebraska
- Study start
- Jul 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 2 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be approached during their regularly scheduled Cancer Center appointments.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Less than 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao H Huang, MD, FACP principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Cell Lung Cancer, run by University of Kansas Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017.