Trial Information

Glycoprotein and Glycan Profiling in Patients With Locally Advanced Cervical Cancer (Stage IB2, IIA > 4 CM, IIB to IVA) Undergoing Pelvic and Para-Aortic (Abdominal) Lymphadenectomy

OBJECTIVES:

Primary

- 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

- 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.

- 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.

- 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.

- 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.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 286 patients will be accrued for this study.