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Ultrastaging of Early Colon Cancer

Phase 1
18 Years
85 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

Ultrastaging of Early Colon Cancer


- Determine whether the immunohistochemical and molecular presence of micrometastases in
≥ 12 lymph nodes removed during en-bloc resection in patients with stage II colon
cancer correlates with 3-year disease-free survival.

- Evaluate the prognostic significance of molecular markers detected in the primary tumor
and develop a microarray-based gene signature for stage II colon cancer.

OUTLINE: This is a multicenter study.

Tumor tissue and regional lymph node samples are collected during surgery for analysis of
micrometastases and molecular markers by immunohistochemistry, qRT-PCR, MM qRT-PCR,
qRDNA-PCR, and microarray profiling.

Patients are followed up periodically for 4 years after surgery.

Inclusion Criteria


- Diagnosis of colon cancer by proctosigmoidoscopy, flexible endoscopy, or
gastrografin/barium enema within the past 8 weeks

- Must have ≥ 12 negative lymph nodes (N0) by standard pathological testing (i.e.,
hematoxylin and eosin staining of a single 4-μm nodal section of each
paraffin-embedded lymph node)

- No evidence of distant metastases by CT scan of the abdomen and pelvis and chest
x-ray or CT scan of the chest within the past 8 weeks

- Preoperative CT scans and testing showing non-specific or non-diagnostic
(equivocal) abnormalities may be allowed pending intraoperative exploration


- ECOG/ZUBROD performance status 0-2

- Life expectancy > 5 years (not including the disease and/or diagnosis of colon

- Not pregnant or nursing

- Negative pregnancy test

- Willing to be followed clinically or by phone, e-mail, or mail correspondence

- No history of any of the following:

- Crohn's disease

- Chronic ulcerative colitis

- Familial polyposis

- No condition requiring emergency surgery (within 2 hours of presentation) to prevent
a life-threatening situation or death, including any of the following:

- Perforated colon

- Metabolically significant complete bowel obstruction

- Early or partial bowel obstruction not requiring emergency surgery allowed

- Massive gastrointestinal bleeding

- Occult bleeding not requiring emergency surgery allowed

- No other malignancy within the past 3 years except for completely resected cervical
cancer, skin cancer, or in-situ cancer


- No prior complete polypectomy by endoscopy

- No concurrent systemic chemotherapy

- No concurrent participation in another research protocol, except during study

Type of Study:


Study Design:

Primary Purpose: Diagnostic

Outcome Measure:

Disease-free survival (time to local or distant recurrence after resection)

Safety Issue:


Principal Investigator

Anton J. Bilchik, MD, PhD, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center



Study ID:




Start Date:

May 2009

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage II colon cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms



Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781