Colorectal CancerNCT01628328
Colonic Stent and Tumor Cell Dissemination
An observational study of Colorectal Cancer, run by The University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients who refuse or who is unable to give informed consent on blood taking for the study.
About this study
Official title: Impact of Metallic Stent Insertion for Obstructing Colorectal Cancer on Circulating 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.
Read the 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).
- Conditions
- Colorectal Cancer
- Keywords
- colonic stenting, colorectal cancer obstruction, circulating tumor cell
- Medical subject headings
- Colorectal Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stenting | patient who received colonic stenting for obstructive colorectal cancer | |
| Control | patients who had only colonoscopy without obstruction and without stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and first 3 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startJul 2010
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jensen TC Poon, MS, Principal investigator, Department of Surgery, University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628328
- Sponsor's protocol ID
- colonstent
- Status last verified
- Jun 2012
- First submitted
- 21 Jun 2012
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Metallic Stent Insertion for Obstructing Colorectal Cancer on Circulating Tumor Cell Dissemination
- ClinicalTrials.gov ID
- NCT01628328
- Acronym / sponsor ID
- colonstent
- Conditions
- Colorectal Cancer
- Keywords
- colonic stenting, colorectal cancer obstruction, circulating tumor cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stenting | – | –patient who received colonic stenting for obstructive colorectal cancer |
| Control | – | –patients who had only colonoscopy without obstruction and without stenting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Colonic stenting group
- 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
Key exclusion criteria (1 listed)
- Patients who refuse or who is unable to give informed consent on blood taking for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jensen TC Poon, MS principal investigator
Department of Surgery, University of Hong Kong
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012.