Circulating Tumor Cells (CTCs) as a Blood-based Tumor Marker in Patients With Small Cell Lung Cancer (SCLC)
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)
1 other identifier
observational
25
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2010
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 27, 2010
CompletedFirst Posted
Study publicly available on registry
August 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedJanuary 10, 2017
January 1, 2017
2.3 years
July 27, 2010
January 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
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.
average 2 years
Study Arms (1)
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
Eligibility Criteria
Eligible patients will be approached during their regularly scheduled Cancer Center appointments.
You may qualify if:
- 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
You may not qualify if:
- Less than 18 years of age.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Kansas Medical Centerlead
- VA Office of Research and Developmentcollaborator
- University of Nebraskacollaborator
Study Sites (2)
University of Kansas Medical Centner
Kansas City, Kansas, 66160, United States
University of Nebraska & Omaha VA
Omaha, Nebraska, 68105, United States
Biospecimen
Blood samples will be collected before treatment begins, at completion of treatment, and every 6 to 8 weeks during follow-up visits.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chao H Huang, MD, FACP
University of Kansas Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2010
First Posted
August 2, 2010
Study Start
July 1, 2010
Primary Completion
November 1, 2012
Study Completion
March 1, 2015
Last Updated
January 10, 2017
Record last verified: 2017-01