Sentinel Lymph Node BiopsyNCT00654342
Comparison Between ex Vivo and in Vivo Injection of Blue Dye in Sentinel Lymph Node Mapping for Colon Cancer
A study testing Intraoperative injection (in vivo) and Postoperative injection (ex vivo) in people with Sentinel Lymph Node Biopsy and Colon Cancer, run by Chung-Ang University at 1 site in South Korea.
Trial summary
The technique of sentinel lymph node mapping in patients with colon cancer varies among reports, and the optimal method remain to be established. The purpose of this study was to determine the optimal injection technique for sentinel lymph node mapping for colon cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sentinel Lymph Node Biopsy, Colon Cancer
- What is being tested?
- Intraoperative injection (in vivo) and Postoperative injection (ex vivo)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2007to Feb 2009
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage I - III colon cancer patients
Who cannot join
- cancer located at the low rectum which were located within 10 cm of the dentate, recurrent or metastatic colon carcinoma, adjacent organ invasion tumor, prior chemotherapy or radiation, cancer with intestinal obstruction, past intestinal surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Surgery, Chung-Ang university Hospital
Seoul, 156-755
About this study
The technique of sentinel lymph node mapping in patients with colon cancer varies among reports, and the optimal method remain to be established. The purpose of this study was to determine the optimal injection technique for sentinel lymph node mapping for colon cancer.
- Conditions
- Sentinel Lymph Node Biopsy, Colon Cancer
- Being tested
- Intraoperative injection (in vivo), Postoperative injection (ex vivo)
- Keywords
- Sentinel lymph node-colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative injection (in vivo)Procedure or surgery
Intraoperative injection
Postoperative injection (ex vivo)Procedure or surgery
postoperative injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | In vivo injection group Receives: Procedure: Intraoperative injection (in vivo) |
| 2 | Other | Ex vivo injection group Receives: Procedure: Postoperative injection (ex vivo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy & sensitivity of sentinel lymph node mapping
Measured: After confirmed pathological report
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2008 (estimated)
- Study startOct 2007
- Primary completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sentinel Lymph Node BiopsyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654342
- Sponsor's protocol ID
- caugs_01
- Status last verified
- Apr 2008
- First submitted
- 2 Apr 2008
- Last updated
- 8 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between ex Vivo and in Vivo Injection of Blue Dye in Sentinel Lymph Node Mapping for Colon Cancer
- ClinicalTrials.gov ID
- NCT00654342
- Acronym / sponsor ID
- caugs_01
- Conditions
- Sentinel Lymph Node Biopsy, Colon Cancer
- Keywords
- Sentinel lymph node-colon cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chung-Ang UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Feb 2009 (estimated)
- First posted
- 8 Apr 2008 (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.
The technique of sentinel lymph node mapping in patients with colon cancer varies among reports, and the optimal method remain to be established. The purpose of this study was to determine the optimal injection technique for sentinel lymph node mapping for colon cancer.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Intraoperative injection (in vivo)In vivo injection group |
| 2 | Other | Procedure: Postoperative injection (ex vivo)Ex vivo injection group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stage I - III colon cancer patients
Key exclusion criteria (1 listed)
- cancer located at the low rectum which were located within 10 cm of the dentate, recurrent or metastatic colon carcinoma, adjacent organ invasion tumor, prior chemotherapy or radiation, cancer with intestinal obstruction, past intestinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative injection (in vivo)Intraoperative injection | Procedure or surgery | 1 |
| Postoperative injection (ex vivo)postoperative injection | Procedure or surgery | 2 |
Primary outcome
Accuracy & sensitivity of sentinel lymph node mapping
Time frame: After confirmed pathological report
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2008.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative injection (in vivo) and Postoperative injection (ex vivo) in people with Sentinel Lymph Node Biopsy and Colon Cancer, run by Chung-Ang University at 1 site in South Korea.
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 1 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: status not confirmed, as of the sponsor's last update on 8 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact In-Taik Chang, M.D., Ph.D. (82-2-6299-1562, caumed5@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy & sensitivity of sentinel lymph node mapping (time frame: After confirmed pathological report). 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 8 Apr 2008.