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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 18
- 主要终点
- Differences in 10 of the 300 carbohydrates under examination using the customized glycan array
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients who do not satisfy pre-entry requirements
结局指标
主要结局
Differences in 10 of the 300 carbohydrates under examination using the customized glycan array
时间窗: Up to 3 years
Differences in approximately 50 of the 400 genes on the customized glycogene expression array
时间窗: Up to 3 years
Level of immunohistochemical staining for Tn antigen and sialyl Tn antigen
时间窗: Up to 3 years
Presence of T-synthase or Cosmc mutation
时间窗: Up to 3 years
次要结局
- Local control(Up to 3 years)
- Lymph node metastasis(Up to 3 years)
- Overall survival(Up to 3 years)
- Progression-free survival (recurrence and disease progression)(Up to 3 years)