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
• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Adenosquamous
• Carcinoma, Small Cell
• Carcinoma, Squamous Cell
• Cervical Adenocarcinoma
• Cervical Adenosquamous Carcinoma
• Cervical Small Cell Carcinoma
• Cervical Squamous Cell Carcinoma, Not Otherwise Specified
• Small Cell Lung Carcinoma
• Stage IB Cervical Cancer
• Stage IIA Cervical Cancer
• Stage IIB Cervical Cancer
• Stage III Cervical Cancer
• Stage IVA Cervical Cancer
• Uterine Cervical Neoplasms

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