Glycoprotein and Glycan in Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer Undergoing Surgery to Remove Pelvic and Abdominal Lymph Nodes
Basic Trial Information
|No phase specified||Biomarker/Laboratory analysis, Diagnostic||Closed||18 and over||NCI, Other||GOG-0221|
NCI-2009-00592, CDR0000540243, U10CA027469, NCT00460356
This clinical trial studies 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. 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.
Further Study Information
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.
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.
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.
- 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
- Patients who do not satisfy pre-entry requirements
Trial Contact Information
Trial Lead Organizations/Sponsors
Gynecologic Oncology Group
- National Cancer Institute
Borgess Medical Center
Raymond Sterling Lord
Bronson Methodist Hospital
Raymond Sterling Lord
West Michigan Cancer Center
Raymond Sterling Lord
Regional Cancer Center at Singing River Hospital
James E. Clarkson
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00460356
ClinicalTrials.gov processed this data on April 09, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.