NCT01628328

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2012

Completed
Last Updated

June 26, 2012

Status Verified

June 1, 2012

Enrollment Period

1.4 years

First QC Date

June 21, 2012

Last Update Submit

June 21, 2012

Conditions

Keywords

colonic stentingcolorectal cancer obstructioncirculating tumor cell

Outcome Measures

Primary Outcomes (1)

  • Changes of circulating tumor cell level before and after colonic stenting for patients with obstructive colorectal cancer

    The patients' peripheral blood will be collected before and on first 3 days after the procedure.

    Before and first 3 days after procedure

Study Arms (2)

Stenting

patient who received colonic stenting for obstructive colorectal cancer

Control

patients who had only colonoscopy without obstruction and without stenting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients who refuse or who is unable to give informed consent on blood taking for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jensen TC Poon, MS

    Department of Surgery, University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2012

First Posted

June 26, 2012

Study Start

July 1, 2010

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

June 26, 2012

Record last verified: 2012-06