Colonic Stent and Tumor Cell Dissemination

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Impact of Metallic Stent Insertion for Obstructing Colorectal Cancer on Circulating Tumor Cell Dissemination

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2012
First posted: Jun 26, 2012
Registry last updated: Jun 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed