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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00460356 |
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 |
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Cervical Cancer |
Procedure: gene expression profiling Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: lymphadenectomy Procedure: mutation analysis |
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 |
Estimated Enrollment: | 286 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary invasive carcinoma of the cervix
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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 |
Study Chair: | Michael A. Gold, MD | Oklahoma University Cancer Institute |
Study ID Numbers: | CDR0000540243, GOG-0221 |
Study First Received: | April 11, 2007 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00460356 |
Health Authority: | Unspecified |
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 |
Epidermoid carcinoma Carcinoma, Small Cell Squamous cell carcinoma Carcinoma, squamous cell Adenocarcinoma |
Carcinoma, Squamous Cell PS-K Carcinoma, Adenosquamous Carcinoma |