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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
isosulfan blue
polymerase chain reaction
diagnostic laboratory biomarker analysis
immunohistochemistry staining method
diagnostic lymphadenectomy
therapeutic conventional surgery
therapeutic lymphadenectomy
Sponsored by
Saint John's Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring stage I colon cancer, stage II colon cancer, stage III colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Sensitivity and accuracy of lymphatic mapping in colorectal cancer
    Overall survival
    Disease-free survival

    Secondary Outcome Measures

    Full Information

    First Posted
    February 27, 2008
    Last Updated
    September 16, 2013
    Sponsor
    Saint John's Cancer Institute
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00625625
    Brief Title
    Lymphatic Mapping, Sentinel Lymph Node Analysis, and Blood Tests in Detecting and Predicting Early Micrometastases in Patients With Colorectal Cancer
    Official Title
    Ultrastaging of Early Cancer of the Large Bowel Using Intraoperative Lymphatic Mapping, Sentinel Node Analysis and Blood Testing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2008
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    November 2007 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Saint John's Cancer Institute
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2
    Enrollment
    225 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    isosulfan blue
    Intervention Type
    Genetic
    Intervention Name(s)
    polymerase chain reaction
    Intervention Type
    Other
    Intervention Name(s)
    diagnostic laboratory biomarker analysis
    Intervention Type
    Other
    Intervention Name(s)
    immunohistochemistry staining method
    Intervention Type
    Procedure
    Intervention Name(s)
    diagnostic lymphadenectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    therapeutic conventional surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    therapeutic lymphadenectomy
    Primary Outcome Measure Information:
    Title
    Sensitivity and accuracy of lymphatic mapping in colorectal cancer
    Title
    Overall survival
    Title
    Disease-free survival

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shamim Baker
    Organizational Affiliation
    Saint John's Cancer Institute

    12. IPD Sharing Statement

    Learn more about this trial

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

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