Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460356
Status:
COMPLETED
Last Update Posted:
2017-08-24
First Post:
2007-04-11
Brief Title:
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
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Glycoprotein and Glycan Profiling in Patients With Locally Advanced Cervical Cancer Stage IB2 IIA gt 4 CM IIB to IVA Undergoing Pelvic and Para-aortic Abdominal Lymphadenectomy
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
PRIMARY OBJECTIVE
I Determine whether the presence of a mutation in T-synthase or Cosmc andor 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 andor 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 recurrenceprogression 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 recurrenceprogression 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 recurrenceprogression 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
I Determine whether the presence of a mutation in T-synthase or Cosmc andor 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 andor 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 recurrenceprogression 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 recurrenceprogression 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 recurrenceprogression 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2009-00592 | REGISTRY | None | None |
| CDR0000540243 | None | None | None |
| GOG-0221 | OTHER | None | None |
| GOG-0221 | OTHER | None | None |
| U10CA180868 | NIH | None | None |