Lymphatic Mapping, Sentinel Lymph Node Analysis, and Blood Tests in Detecting and Predicting Early Micrometastases in Patients With Colorectal Cancer
NCT ID: NCT00625625
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
225 participants
INTERVENTIONAL
2004-03-31
Brief Summary
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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
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* 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
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Keywords
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Study Design
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DIAGNOSTIC
Interventions
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isosulfan blue
polymerase chain reaction
diagnostic laboratory biomarker analysis
immunohistochemistry staining method
diagnostic lymphadenectomy
therapeutic conventional surgery
therapeutic lymphadenectomy
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Saint John's Cancer Institute
OTHER
Principal Investigators
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Shamim Baker
Role:
Saint John's Cancer Institute
Other Identifiers
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JWCI-GULS-CRCSLN-0104
Identifier Type: -
Identifier Source: secondary_id
CDR0000586464
Identifier Type: -
Identifier Source: org_study_id