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| ID | Type | Description | Link |
|---|---|---|---|
| JWCI-GULS-CRCSLN-0104 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| isosulfan blue | Drug | |||
| polymerase chain reaction | Genetic | |||
| diagnostic laboratory biomarker analysis | Other | |||
| immunohistochemistry staining method | Other | |||
| diagnostic lymphadenectomy | Procedure | |||
| therapeutic conventional surgery | Procedure | |||
| therapeutic lymphadenectomy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and accuracy of lymphatic mapping in colorectal cancer | ||
| Overall survival | ||
| Disease-free survival |
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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
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Shamim Baker | Saint John's Cancer Institute |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C025484 | iso-sulfan blue |
| D016133 | Polymerase Chain Reaction |
| D007150 | Immunohistochemistry |
| ID | Term |
|---|---|
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D007158 | Immunologic Techniques |
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