Studying Lymph Nodes in Patients With Stage II Colon Cancer

OBJECTIVES:

- 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: All of the following inclusion criteria must be met in order for the
subject to be eligible.

1. Subjects must have CC detected by proctosigmoidoscopy, flexible endoscopy, or
gastrograffin/barium enema, with no evidence of distant metastases within 8 weeks of
enrollment.

2. Subjects with CC must have a computerized tomography (CT; at a minimum - spiral
(helical) CT with 5-mm contiguous reconstruction algorithms and adequate volume (based
on site-specific protocols) of oral and intravenous contrast agents) of the abdomen
and pelvis and a chest x-ray or CT of the chest per standard of care, within 8 weeks
prior to enrollment to rule out distant metastases. Subjects with preoperative CT
scans and testing showing non-specific or non-diagnostic (equivocal) abnormalities may
be eligible pending intraoperative exploration.

3. Greater than 18 years of age

4. Subjects must have a performance status ≤ 2 on the ECOG/Zubrod scale.

5. Subject is able to give informed consent, and must be willing to be followed
clinically or by phone/email/mail correspondence

6. Subject must have a life expectancy of greater than 5 years not including the
disease/diagnosis of CC.

7. Subject must have clinical assessment conducted by phone unless patients follow up are
part of the regular clinical visits.

Exclusion Criteria: Any of the following criteria will exclude the subject from the study.

1. Subjects requiring emergent surgery (within 2 hours of presentation) to prevent a
life-threatening situation or death such as those with a perforated colon,
metabolically significant complete bowel obstruction or massive GI bleeding will be
excluded. Subjects who do not require emergent surgery, such as those with occult
bleeding or early or partial bowel obstruction will be permitted to enter.

2. Subjects with any history of Crohn's disease, chronic ulcerative colitis, or familial
polyposis.

3. Discovery of distant metastases intra-operatively.

4. Subjects with history of another malignancy over the last three years (except for
completely resected cervical, skin cancers or in-situ cancers - see Appendix B for a
list of exempt cancers).

5. Pregnant and/or lactating women. Potentially childbearing subjects (pre-menopausal
women) should undergo a pregnancy test within 7 days prior to surgery and after
signing consent. Subjects found to be pregnant will be ineligible and withdrawn from
the study.

6. Subjects should not be participating in another research protocol at the time of
enrollment. Participation during follow-up is acceptable.

7. Systemic chemotherapy for node negative colon cancer.

8. Complete polypectomy by endoscopy

9. Less than 12 lymph nodes