Colorectal CancerPhase 2NCT00625625
Lymphatic Mapping, Sentinel Lymph Node Analysis, and Blood Tests in Detecting and Predicting Early Micrometastases in Patients With Colorectal Cancer
A Phase 2 study testing isosulfan blue, polymerase chain reaction and diagnostic laboratory biomarker analysis in people with Colorectal Cancer, run by Saint John's Cancer Institute.
Trial summary
RATIONALE: Diagnostic procedures, such as lymph node mapping during surgery and sentinel lymph node biopsy, may help doctors find micrometastases and predict cancer recurrence. PURPOSE: This phase II trial is studying how well lymph node mapping during surgery together with sentinel lymph node analysis and blood… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- isosulfan blue, polymerase chain reaction and diagnostic laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Nov 2007
- Phase
- Phase 2
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of colorectal cancer as detected by proctosigmoidoscopy, flexible endoscopy, or gastrografin/barium enema
- No evidence of distant metastases by CT scan of the abdomen and pelvis AND chest x-ray or CT scan of the chest performed within 6 weeks prior to enrollment
- Preoperative CT scans and testing showing non-specific or non-diagnostic (equivocal) abnormalities may be eligible pending intraoperative exploration
- No discovery of distant metastases intra-operatively
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) or Zubrod PS equal to 2
- Life expectancy > 5 years not including the disease/diagnosis of colorectal cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No requirement for emergent surgery (within 2 hours of presentation) to prevent a life-threatening situation or death including:
- Perforated colon
- Metabolically significant complete bowel obstruction
- Massive GI bleeding
- Occult bleeding or early or partial bowel obstruction not requiring emergent surgery allowed
- No history of Crohn disease, chronic ulcerative colitis, or familial polyposis
- No other malignancy within the past 3 years except for completely resected cervical cancer, skin cancer, or in situ cancer
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- See Patient Characteristics
- No concurrent participation in another research protocol
- Participation during follow up allowed
About this study
Official title: Ultrastaging of Early Cancer of the Large Bowel Using Intraoperative Lymphatic Mapping, Sentinel Node Analysis and Blood Testing
RATIONALE: Diagnostic procedures, such as lymph node mapping during surgery and sentinel lymph node biopsy, may help doctors find micrometastases and predict cancer recurrence.
PURPOSE: This phase II trial is studying how well lymph node mapping during surgery together with sentinel lymph node analysis and blood testing work in detecting and predicting early micrometastases in patients with colorectal cancer.
Read the detailed description
OBJECTIVES:
- To determine the accuracy and sensitivity of intraoperative lymph node mapping with isosulfan blue and sentinal node biopsy (SLN) in patients with colorectal cancer (CRC).
- To compare molecular and immunohistochemical methods for detection of micrometastases in the SLN and primary tumor and evaluate the clinical outcome.
- To evaluate the clinicopathological utility of hematogenous micrometastases in predicting disease recurrence in CRC.
OUTLINE: Patients receive isosulfan blue subserosally around the primary tumor for sentinel lymph node (SLN) identification and SLN(s) are marked. Patients undergo a standard colon resection as planned to include the SLN(s) and regional lymph nodes.
Lymph nodes removed during surgery are analyzed within 30 days after surgery. Routine pathologic analysis (H\&E) are performed on all lymph nodes (SLN and non-SLN) removed. Immunohistochemical (IHC) staining for cytokeratin antibodies AE-1/AE-3 or MAK-6 are performed on all lymph nodes negative by H\&E. Multimarker PCR (MM PCR) are performed on all SLNs. Blood samples are collected at baseline and then periodically for 4 years for MM PCR to detect circulating tumor cells and standard tumor markers (e.g., CEA).
After surgery, patients are followed every 6 months for 4 years.
- Conditions
- Colorectal Cancer
- Being tested
- isosulfan blue, polymerase chain reaction, diagnostic laboratory biomarker analysis, immunohistochemistry staining method, diagnostic lymphadenectomy
- Keywords
- stage I colon cancer, stage II colon cancer, stage III colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isosulfan blueDrug
polymerase chain reactionGenetic
diagnostic laboratory biomarker analysisOther
diagnostic lymphadenectomyProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
therapeutic lymphadenectomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and accuracy of lymphatic mapping in colorectal cancer
Overall survival
Disease-free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startMar 2004
- Primary completionNov 2007 (estimated)
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.
- 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 2
- Primary purpose
- Diagnosis
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint John's Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Shamim Baker, Saint John's Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625625
- Sponsor's protocol ID
- CDR0000586464
- Other IDs
- JWCI-GULS-CRCSLN-0104
- Status last verified
- Feb 2008
- First submitted
- 27 Feb 2008
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrastaging of Early Cancer of the Large Bowel Using Intraoperative Lymphatic Mapping, Sentinel Node Analysis and Blood Testing
- ClinicalTrials.gov ID
- NCT00625625
- Acronym / sponsor ID
- CDR0000586464
- Conditions
- Colorectal Cancer
- Keywords
- stage I colon cancer, stage II colon cancer, stage III colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Saint John's Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2004
- Primary completion
- Nov 2007 (estimated)
- First posted
- 28 Feb 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.
RATIONALE: Diagnostic procedures, such as lymph node mapping during surgery and sentinel lymph node biopsy, may help doctors find micrometastases and predict cancer recurrence.
PURPOSE: This phase II trial is studying how well lymph node mapping during surgery together with sentinel lymph node analysis and blood testing work in detecting and predicting early micrometastases in patients with colorectal cancer.
Detailed description
OBJECTIVES:
- To determine the accuracy and sensitivity of intraoperative lymph node mapping with isosulfan blue and sentinal node biopsy (SLN) in patients with colorectal cancer (CRC).
- To compare molecular and immunohistochemical methods for detection of micrometastases in the SLN and primary tumor and evaluate the clinical outcome.
- To evaluate the clinicopathological utility of hematogenous micrometastases in predicting disease recurrence in CRC.
OUTLINE: Patients receive isosulfan blue subserosally around the primary tumor for sentinel lymph node (SLN) identification and SLN(s) are marked. Patients undergo a standard colon resection as planned to include the SLN(s) and regional lymph nodes.
Lymph nodes removed during surgery are analyzed within 30 days after surgery. Routine pathologic analysis (H\&E) are performed on all lymph nodes (SLN and non-SLN) removed. Immunohistochemical (IHC) staining for cytokeratin antibodies AE-1/AE-3 or MAK-6 are performed on all lymph nodes negative by H\&E. Multimarker PCR (MM PCR) are performed on all SLNs. Blood samples are collected at baseline and then periodically for 4 years for MM PCR to detect circulating tumor cells and standard tumor markers (e.g., CEA).
After surgery, patients are followed every 6 months for 4 years.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| isosulfan blue | Drug | – |
| polymerase chain reaction | Genetic | – |
| diagnostic laboratory biomarker analysis | Other | – |
| immunohistochemistry staining method | Other | – |
| diagnostic lymphadenectomy | Procedure or surgery | – |
| therapeutic conventional surgery | Procedure or surgery | – |
| therapeutic lymphadenectomy | Procedure or surgery | – |
Primary outcome
Sensitivity and accuracy of lymphatic mapping in colorectal cancer
Overall survival
Disease-free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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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.
Shamim Baker
Saint John's Cancer Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing isosulfan blue, polymerase chain reaction and diagnostic laboratory biomarker analysis in people with Colorectal Cancer, run by Saint John's Cancer Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Sep 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Sensitivity and accuracy of lymphatic mapping in colorectal cancer. The study lists 3 primary outcomes in all. 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 17 Sep 2013.