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Lymphatic Mapping, Sentinel Lymph Node Analysis, and Blood Tests in Detecting and Predicting Early Micrometastases in Patients With Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00625625
Recruitment Status : Unknown
Verified February 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : February 28, 2008
Last Update Posted : September 17, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief 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 testing work in detecting and predicting early micrometastases in patients with colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: isosulfan blue Genetic: polymerase chain reaction Other: diagnostic laboratory biomarker analysis Other: immunohistochemistry staining method Procedure: diagnostic lymphadenectomy Procedure: therapeutic conventional surgery Procedure: therapeutic lymphadenectomy Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Primary Purpose: Diagnostic
Official Title: Ultrastaging of Early Cancer of the Large Bowel Using Intraoperative Lymphatic Mapping, Sentinel Node Analysis and Blood Testing
Study Start Date : March 2004
Estimated Primary Completion Date : November 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Sensitivity and accuracy of lymphatic mapping in colorectal cancer
  2. Overall survival
  3. Disease-free survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics
  • See Patient Characteristics
  • No concurrent participation in another research protocol

    • Participation during follow up allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00625625

Sponsors and Collaborators
John Wayne Cancer Institute
National Cancer Institute (NCI)
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OverallOfficial: Shamim Baker John Wayne Cancer Institute
Layout table for additonal information Identifier: NCT00625625    
Other Study ID Numbers: CDR0000586464
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: February 2008
Keywords provided by National Cancer Institute (NCI):
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases