Glycoprotein and Glycan in Tissue and Blood Samples of Patients With Stage IB-IVA Cervical Cancer Undergoing Surgery to Remove Pelvic and Abdominal Lymph Nodes

PRIMARY OBJECTIVE:

I. Determine whether the presence of a mutation in T-synthase or Cosmc and/or the presence of
positive immunohistochemical expression of Tn antigen or sialyl Tn antigen in tumor specimens
is associated with progression-free or overall survival in patients with stage IB2, II, III,
or IVA cervical cancer undergoing pelvic and para-aortic (abdominal) lymphadenectomy.

SECONDARY OBJECTIVES:

I. Determine whether the presence of a mutation in T-synthase or Cosmc and/or the presence of
positive immunohistochemical expression of Tn antigen or sialyl Tn antigen in tumor specimens
is associated with lymph node metastasis or local control.

II. Identify a glycoprotein profile from a customized gene expression array analysis in tumor
specimens or a glycan profile from a customized glycan array in serum that is associated with
lymph node metastasis, local control, disease recurrence/progression, or survival.

III. Determine whether differences exist in T-synthase or Cosmc mutations, the
immunohistochemical expression of Tn antigen or sialyl Tn antigen, and glycoprotein profiling
(using customized gene expression array analysis) in matched primary tumor compared with
metastatic lymph nodes that are associated with lymph node metastasis, local control, disease
recurrence/progression, or survival.

IV. Identify differences in glycoprotein expression profiling and glycan profiling in tumor
specimens with or without a mutation in T-synthase or Cosmc, or in tumor specimens with or
without positive immunohistochemical expression of Tn antigen or sialyl Tn antigen that are
associated with lymph node metastasis, local control, disease recurrence/progression, or
survival.

OUTLINE:

Primary and metastatic tumor specimens are collected during lymphadenectomy and used for
tissue microarray analysis, mutational analysis of T-synthase and Cosmc, immunohistochemical
staining of Tn antigen and sialyl Tn antigen, and customized gene expression array analysis
of 400 genes associated with glycobiology. Pre-lymphadenectomy blood is collected from
patients at baseline for customized glycan array analysis of 300 carbohydrates.

After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria:

- Patients with primary, previously untreated, histologically confirmed locoregionally
advanced (Stages IB2, IIA > 4 cm, IIB-IVA) invasive carcinoma of the cervix (any cell
type) who will undergo pelvic and para-aortic (abdominal) lymphadenectomy to determine
the presence or absence of lymph node metastasis

- Patients who have met the pre-entry requirements

- Patients with a block or 25 unstained sections of formalin-fixed and paraffin-embedded
primary tumor available to satisfy the primary tumor requirement

- Patients who have signed an approved informed consent and authorization permitting
release of personal health information

Exclusion Criteria:

- Patients who do not satisfy pre-entry requirements