Colonic Stent and Tumor Cell Dissemination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01628328
First received: June 21, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Impact of Metallic Stent Insertion for Obstructing Colorectal Cancer on Circulating Tumor Cell Dissemination

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

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 ] [ Designated as safety issue: No ]
    The patients' peripheral blood will be collected before and on first 3 days after the procedure.


Enrollment: 40
Study Start Date: July 2010
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stenting
patient who received colonic stenting for obstructive colorectal cancer
Control
patients who had only colonoscopy without obstruction and without stenting

Detailed Description:
  1. 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

    1. Patients with obstructive colorectal cancer that requires colonic stenting as treatment
    2. Age > 18 years and is able to give informed consent
    3. Informed consent for blood collection obtained

    Control group

    1. Patients with colorectal cancer who have colonoscopy without stenting
    2. Age > 18 years and is able to give informed consent
    3. Informed consent for blood collection obtained
  2. 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Colonic stenting group

    1. Patients with obstructive colorectal cancer that requires colonic stenting as treatment
    2. Age > 18 years and is able to give informed consent
    3. Informed consent for blood collection obtained

Control group

  1. Patients with colorectal cancer who have colonoscopy without stenting
  2. Age > 18 years and is able to give informed consent
  3. 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.
  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: NCT01628328

Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Jensen TC Poon, MS Department of Surgery, University of Hong Kong
  More Information

No publications provided

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01628328     History of Changes
Other Study ID Numbers: colonstent
Study First Received: June 21, 2012
Last Updated: June 21, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
colonic stenting
colorectal cancer obstruction
circulating tumor cell

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplastic Cells, Circulating
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Rectal Diseases

ClinicalTrials.gov processed this record on October 21, 2014