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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00625625
• Date of registration: 27/02/2008
• Primary sponsor: John Wayne Cancer Institute at Saint John's Health Center
• Public title: Lymphatic Mapping, Sentinel Lymph Node Analysis, and Blood Tests in Detecting and Predicting Early Micrometastases in Patients With Colorectal Cancer
• Scientific title: Ultrastaging of Early Cancer of the Large Bowel Using Intraoperative Lymphatic Mapping, Sentinel Node Analysis and Blood Testing
• Date of first enrolment: March 2004
• Target sample size: 225
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00625625
• Study type: Interventional
• Study design: Primary Purpose: Diagnostic

Contacts

• Name: Shamim Baker
• Affiliation: John Wayne Cancer Institute at Saint John's Health Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Colorectal Cancer

Intervention(s)

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

Primary Outcome(s)

Disease-free survival [Time Frame: No]

Overall survival [Time Frame: No]

Sensitivity and accuracy of lymphatic mapping in colorectal cancer [Time Frame: No]

Secondary ID(s)

CDR0000586464

JWCI-GULS-CRCSLN-0104

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)