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

Completed

• Conditions: Cervical Adenosquamous Carcinoma; Stage IB Cervical Cancer; Stage IIA Cervical Cancer; Stage III Cervical Cancer; Cervical Small Cell Carcinoma; Cervical Squamous Cell Carcinoma, Not Otherwise Specified; Stage IVA Cervical Cancer; Cervical Adenocarcinoma; Stage IIB Cervical Cancer
• Interventions: Other: Laboratory Biomarker Analysis; Procedure: Lymphadenectomy

• Registration Number: NCT00460356
• Lead Sponsor: Gynecologic Oncology Group

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 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.

Study Timeline

• Study Start: 2007-04-02
• Study First Submitted: 2007-04-11
• Study First Submitted QC: 2007-04-11
• Study First Posted: 2007-04-13
• Primary Completion: 2016-07-16
• Study Completion: 2016-07-16
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-23
• Last Update Posted: 2017-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 159

Inclusion Criteria

• 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

Exclusion Criteria

• Patients who do not satisfy pre-entry requirements

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (glycoprotein and glycan profiling)	Laboratory Biomarker Analysis	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.
Ancillary-Correlative (glycoprotein and glycan profiling)	Lymphadenectomy	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.

Primary Outcome Measures

Name	Time	Method
Differences in 10 of the 300 carbohydrates under examination using the customized glycan array	Up to 3 years
Differences in approximately 50 of the 400 genes on the customized glycogene expression array	Up to 3 years
Level of immunohistochemical staining for Tn antigen and sialyl Tn antigen	Up to 3 years
Presence of T-synthase or Cosmc mutation	Up to 3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (18)

Oklahoma Cancer Specialists and Research Institute-Tulsa; 🇺🇸 Tulsa, Oklahoma, United States

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States

Women's Cancer Center of Nevada; 🇺🇸 Las Vegas, Nevada, United States

University of Cincinnati/Barrett Cancer Center; 🇺🇸 Cincinnati, Ohio, United States

Sunrise Hospital and Medical Center; 🇺🇸 Las Vegas, Nevada, United States

Cleveland Clinic Cancer Center/Fairview Hospital; 🇺🇸 Cleveland, Ohio, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center; 🇺🇸 Orange, California, United States

Wayne State University/Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Augusta University Medical Center; 🇺🇸 Augusta, Georgia, United States

Saint Louis University Hospital; 🇺🇸 Saint Louis, Missouri, United States

Olive View-University of California Los Angeles Medical Center; 🇺🇸 Sylmar, California, United States

Hillcrest Hospital Cancer Center; 🇺🇸 Mayfield Heights, Ohio, United States

Montefiore Medical Center-Einstein Campus; 🇺🇸 The Bronx, New York, United States

Summa Akron City Hospital/Cooper Cancer Center; 🇺🇸 Akron, Ohio, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Women and Infants Hospital; 🇺🇸 Providence, Rhode Island, United States

Lake University Ireland Cancer Center; 🇺🇸 Mentor, Ohio, United States