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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
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00460356
  Purpose

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.


Condition Intervention
Cervical Cancer
Procedure: gene expression profiling
Procedure: immunohistochemistry staining method
Procedure: laboratory biomarker analysis
Procedure: lymphadenectomy
Procedure: mutation analysis

MedlinePlus related topics: Cancer
Drug Information available for: Krestin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: 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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Presence of T-synthase or Cosmc mutation [ Designated as safety issue: No ]
  • Level of immunohistochemical staining for Tn antigen and sialyl Tn antigen [ Designated as safety issue: No ]
  • Differences in approximately 50 of the 400 genes on the customized glycogene expression array [ Designated as safety issue: No ]
  • Differences in 10 of the 300 carbohydrates under examination using the customized glycan array [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lymph node metastasis [ Designated as safety issue: No ]
  • Local control [ Designated as safety issue: No ]
  • Progression-free survival (recurrence and disease progression) [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 286
Study Start Date: March 2007
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460356

Locations
United States, California
Olive View - UCLA Medical Center Foundation Recruiting
Sylmar, California, United States, 91342
Contact: Christine Holschneider, MD     310-206-5161        
United States, Michigan
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord, MD     269-373-7458        
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord, MD     269-373-7458        
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center     269-373-7458        
United States, Mississippi
Regional Cancer Center at Singing River Hospital Recruiting
Pascagoula, Mississippi, United States, 39581
Contact: James E. Clarkson, MD     228-374-6296        
United States, Missouri
Saint Louis University Cancer Center Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Clinical Trials Office - Saint Louis University Cancer Center     314-977-4440        
United States, Ohio
David L. Rike Cancer Center at Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Clinical Trials Office - David L. Rike Cancer Center at Miami     937-208-2079        
United States, Oklahoma
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Robert S. Mannel, MD     405-271-8787        
United States, Rhode Island
Women and Infants Hospital of Rhode Island Recruiting
Providence, Rhode Island, United States, 02905
Contact: Clinical Trials Office - Women and Infants Hospital of Rhode I     401-274-1122        
United States, Wisconsin
Gundersen Lutheran Center for Cancer and Blood Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center     608-775-2385     cancerctr@gundluth.org    
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Michael A. Gold, MD Oklahoma University Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000540243, GOG-0221
Study First Received: April 11, 2007
Last Updated: December 10, 2008
ClinicalTrials.gov Identifier: NCT00460356  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IB cervical cancer
stage IIA cervical cancer
stage IIB cervical cancer
stage III cervical cancer
stage IVA cervical cancer
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical small cell carcinoma
cervical squamous cell carcinoma

Study placed in the following topic categories:
Epidermoid carcinoma
Carcinoma, Small Cell
Squamous cell carcinoma
Carcinoma, squamous cell
Adenocarcinoma
Carcinoma, Squamous Cell
PS-K
Carcinoma, Adenosquamous
Carcinoma

ClinicalTrials.gov processed this record on January 16, 2009