Colonic Stent and Tumor Cell Dissemination
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ClinicalTrials.gov Identifier: NCT01628328 |
Recruitment Status
:
Completed
First Posted
: June 26, 2012
Last Update Posted
: June 26, 2012
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Tracking Information | ||||
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First Submitted Date | June 21, 2012 | |||
First Posted Date | June 26, 2012 | |||
Last Update Posted Date | June 26, 2012 | |||
Study Start Date | July 2010 | |||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Changes of circulating tumor cell level before and after colonic stenting for patients with obstructive colorectal cancer [ Time Frame: Before and first 3 days after procedure ] The patients' peripheral blood will be collected before and on first 3 days after the procedure.
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Original Primary Outcome Measures | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Colonic Stent and Tumor Cell Dissemination | |||
Official Title | Impact of Metallic Stent Insertion for Obstructing Colorectal Cancer on Circulating Tumor Cell Dissemination | |||
Brief Summary | This study aims to examine the hypothesis of tumor cell dissemination after colonic stenting for obstructing colorectal cancer by measuring the level of plasma circulating tumor cell before and after the procedure of successful colonic stenting in patients. | |||
Detailed Description |
About 10ml of EDTA blood will be collected for examination before the procedure (colonoscopic stenting or colonoscopy in the control group) and blood collection daily will be repeated for 3 days after procedure. Blood will be sent to the laboratory for processing within 2 hours of withdrawal. Circulating tumour cells, which are characterized by CD45- (to exclude hematopoietic cells), CD326+ (to mark epithelial cells), CK18+ and CK19+ (to mark intestinal cells), i.e. cells expressing CD45-CD326+CK18/19+, will be detected by fluorescence activated cell sorting (FACS). For each ml of blood, 1 ml of FCM Lysing solution will be added and allowed to incubate for 5 minutes to lyse the red blood cells, followed by centrifugation at 1000 RPM for 5 minutes. Supernatant will then be aspirated, and the pellet resuspend in approximately 1 ml cold 1X PBS. 10 µl of the appropriate antibody will be added into the tubes, vortexed and incubated for 15 in dark and room temperature. After incubation, cells will be washed with PBS and then incubated with the second antibody. The process is repeated until all 4 antibodies have been labelled to the cells. Cells will then be analysed on a FACS machine (MoFlo, Beckman Coulter). |
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Study Type | Observational | |||
Study Design | Observational Model: Case Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | The study plan to recruit 20-30 patients in the stenting group and about 10-20 patients in the control groups. There is no previous study on this topic and hence, no information availabe for statistical analysis of sample size required to show a difference. |
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Condition | Colorectal Cancer | |||
Intervention | Not Provided | |||
Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
40 | |||
Original Actual Enrollment | Same as current | |||
Actual Study Completion Date | January 2012 | |||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Control group
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01628328 | |||
Other Study ID Numbers | colonstent | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | The University of Hong Kong | |||
Study Sponsor | The University of Hong Kong | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | The University of Hong Kong | |||
Verification Date | June 2012 |