Colon CancerNCT00419978
The Significance of Sentinel Node Analysis in Colon Cancer
A study testing Colectomy in people with Colon Cancer, run by Legacy Health System at 1 site in United States.
Trial summary
This study is for the patient with colon cancer, who is going to have colon cancer surgery. The purpose of this research study is to examine a specific lymph node, called the sentinel node. Lymph nodes are located throughout your body and cancer may spread by means of those lymph nodes. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Colectomy
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to May 2008
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must consent to participate in study
- Patients will be tracked for five years
- A blood test (CEA) will be collected every six months
- A CT scan will be performed annually
- A colonoscopy will be performed at 1 and 5 years post-surgery
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210
About this study
This study is for the patient with colon cancer, who is going to have colon cancer surgery. The purpose of this research study is to examine a specific lymph node, called the sentinel node. Lymph nodes are located throughout your body and cancer may spread by means of those lymph nodes. The sentinel node is the one located closest to your tumor. This study will find out if examining the sentinel node can help to predict disease progression. Since the value of this exam is unknown, taking part in this study will not change your clinical care.
- Conditions
- Colon Cancer
- Being tested
- Colectomy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColectomyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2007 (estimated)
- Study startJun 2004
- Study completionMay 2008
Why it stopped: Slow accrural to study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Investigators
- Mark Whiteford, MD, Principal investigator, Legayc Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419978
- Sponsor's protocol ID
- 750040399
- Status last verified
- Jun 2008
- First submitted
- 5 Jan 2007
- Last updated
- 4 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of Sentinel Node Analysis in Colon Cancer
- ClinicalTrials.gov ID
- NCT00419978
- Acronym / sponsor ID
- 750040399
- Conditions
- Colon Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrural to study.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Study start
- Jun 2004
- Study completion
- May 2008 (actual)
- First posted
- 9 Jan 2007 (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 is for the patient with colon cancer, who is going to have colon cancer surgery. The purpose of this research study is to examine a specific lymph node, called the sentinel node. Lymph nodes are located throughout your body and cancer may spread by means of those lymph nodes. The sentinel node is the one located closest to your tumor. This study will find out if examining the sentinel node can help to predict disease progression. Since the value of this exam is unknown, taking part in this study will not change your clinical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients must consent to participate in study
- Patients will be tracked for five years
- A blood test (CEA) will be collected every six months
- A CT scan will be performed annually
- A colonoscopy will be performed at 1 and 5 years post-surgery
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Colectomy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Slow accrural to study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2008.
- Legacy's internet websiteLink provided by the sponsor.
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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.
Mark Whiteford, MD principal investigator
Legayc Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colectomy in people with Colon Cancer, run by Legacy Health System at 1 site in United States.
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 5 inclusion and 0 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: stopped early, as of the sponsor's last update on 4 Jul 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 United States. 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?
The study was stopped early (reason given: Slow accrural to study.). Results are not available in the source record.
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.
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 4 Jul 2008.