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NCT00460356 Clinical Trial

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

Cervical Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00460356
Other study ID # GOG-0221
Secondary ID NCI-2009-00592CD
Status Completed
Phase N/A
First received April 11, 2007
Last updated August 23, 2017
Start date April 2, 2007
Est. completion date July 16, 2016

Study information
Verified date August 2017
Source Gynecologic Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 159
Est. completion date July 16, 2016
Est. primary completion date July 16, 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies
Procedure:
• Lymphadenectomy
Undergo lymphadenectomy

Locations
Country Name City State
United States Summa Akron City Hospital/Cooper Cancer Center Akron Ohio
United States Augusta University Medical Center Augusta Georgia
United States University of Cincinnati/Barrett Cancer Center Cincinnati Ohio
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Sunrise Hospital and Medical Center Las Vegas Nevada
United States Women's Cancer Center of Nevada Las Vegas Nevada
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Lake University Ireland Cancer Center Mentor Ohio
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Women and Infants Hospital Providence Rhode Island
United States Saint Louis University Hospital Saint Louis Missouri
United States Olive View-University of California Los Angeles Medical Center Sylmar California
United States Montefiore Medical Center-Einstein Campus The Bronx New York
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma

Sponsors (2)
Lead Sponsor Collaborator
Gynecologic Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Differences in 10 of the 300 carbohydrates under examination using the customized glycan array Up to 3 years
Primary Differences in approximately 50 of the 400 genes on the customized glycogene expression array Up to 3 years
Primary Level of immunohistochemical staining for Tn antigen and sialyl Tn antigen Up to 3 years
Primary Presence of T-synthase or Cosmc mutation Up to 3 years
Secondary Local control Up to 3 years
Secondary Lymph node metastasis Up to 3 years
Secondary Overall survival Up to 3 years
Secondary Progression-free survival (recurrence and disease progression) Up to 3 years
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