Cervical Adenocarcinoma Clinical Trial
Official title:
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
This clinical trial studies 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. Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may also help doctors learn how far the disease has spread.
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.
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