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
| City: |
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Oklahoma City |
| State: |
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Oklahoma |
| Zip Code: |
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73104 |
| Conditions: |
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Cervical Cancer |
| Purpose: |
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RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the
laboratory may help doctors learn more about changes that occur in DNA and identify
biomarkers related to cancer. It may also help doctors learn how far the disease has spread.
PURPOSE: This clinical trial is studying glycoprotein and glycan in patients with stage IB,
stage II, stage III, or stage IVA cervical cancer undergoing surgery to remove pelvic and
abdominal lymph nodes.
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| Study Summary: |
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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.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed primary invasive carcinoma of the cervix
- Any cell type
- Locoregionally advanced (stage IB2, IIA [tumor > 4 cm], IIB, III, or IVA) disease
- Previously untreated disease
- Undergoing a pelvic and para-aortic (abdominal) lymphadenectomy to determine the
presence or absence of lymph node metastasis
- Must have a block or 25 unstained sections of formalin-fixed and paraffin-embedded
primary tumor tissue available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
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| NCT ID: |
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NCT00460356 |
| Primary Contact: |
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Study Chair
Michael A. Gold, MD
Oklahoma University Cancer Institute
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| Backup Contact: |
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N/A |
| Location Contact: |
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Oklahoma City, Oklahoma 73104
United States
Robert S. Mannel, MD
Phone: 405-271-8787
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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