Colonic Stent and Tumor Cell Dissemination

Tracking Information
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; (submitted: June 21, 2012)	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.
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	Patient recruitment: Patients will be recruited from the Division of Colorectal Surgery, Department of Surgery, the University of Hong Kong, over a 12 - 18 months period. Our institution is a tertiary referral center for colorectal cancer patients in Hong Kong. Informed consent will be obtained from the patients after the inclusion criteria are met. The study plans to recruit 25 patients in the colonic stenting group to compare with 15 patients in the control group. Inclusion criteria: Colonic stenting group Patients with obstructive colorectal cancer that requires colonic stenting as treatment Age > 18 years and is able to give informed consent Informed consent for blood collection obtained Control group Patients with colorectal cancer who have colonoscopy without stenting Age > 18 years and is able to give informed consent Informed consent for blood collection obtained; Blood collection and examination for circulating tumor cell 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).
Study Type	Observational
Study Design	Observational Model: Case Control; Time Perspective: Prospective
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.
Condition	Colorectal Cancer
Intervention	Not Provided
Study Groups/Cohorts	Stenting patient who received colonic stenting for obstructive colorectal cancer; Control patients who had only colonoscopy without obstruction and without stenting
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: June 21, 2012)	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: Colonic stenting group Patients with obstructive colorectal cancer that requires colonic stenting as treatment Age > 18 years and is able to give informed consent Informed consent for blood collection obtained Control group; Patients with colorectal cancer who have colonoscopy without stenting; Age > 18 years and is able to give informed consent; Informed consent for blood collection obtained Exclusion Criteria: Patients who refuse or who is unable to give informed consent on blood taking for the study.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
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	Principal Investigator: Jensen TC Poon, MS Department of Surgery, University of Hong Kong
PRS Account	The University of Hong Kong
Verification Date	June 2012