Clinical trial NCT00460356: 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
Official title: Glycoprotein and Glycan Profiling in Patients With Locally Advanced Cervical Cancer (Stage IB2, IIA &gt; 4 CM, IIB to IVA) Undergoing Pelvic and Para-aortic (Abdominal) Lymphadenectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Small Cell Carcinoma
Cervical Squamous Cell Carcinoma, Not Otherwise Specified
Stage IB Cervical Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage IVA Cervical Cancer
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-04-13
Enrollment: 159
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in 10 of the 300 carbohydrates under examination using the customized glycan array
timeFrame: Up to 3 years
measure: Differences in approximately 50 of the 400 genes on the customized glycogene expression array
timeFrame: Up to 3 years
measure: Level of immunohistochemical staining for Tn antigen and sialyl Tn antigen
timeFrame: Up to 3 years
measure: Presence of T-synthase or Cosmc mutation
timeFrame: Up to 3 years
Secondary outcomes:
measure: Local control
timeFrame: Up to 3 years
measure: Lymph node metastasis
timeFrame: Up to 3 years
measure: Overall survival
timeFrame: Up to 3 years
measure: Progression-free survival (recurrence and disease progression)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Health/Chao Family Comprehensive Cancer Center
state: California
city: Sylmar
country: United States
facility: Olive View-University of California Los Angeles Medical Center
state: California
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: Detroit
country: United States
facility: Wayne State University/Karmanos Cancer Institute
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University Hospital
state: Missouri
city: Las Vegas
country: United States
facility: Sunrise Hospital and Medical Center
state: Nevada
city: Las Vegas
country: United States
facility: Women's Cancer Center of Nevada
state: Nevada
city: The Bronx
country: United States
facility: Montefiore Medical Center-Einstein Campus
state: New York
city: Akron
country: United States
facility: Summa Akron City Hospital/Cooper Cancer Center
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati/Barrett Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Cancer Center/Fairview Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Mayfield Heights
country: United States
facility: Hillcrest Hospital Cancer Center
state: Ohio
city: Mentor
country: United States
facility: Lake University Ireland Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute-Tulsa
state: Oklahoma
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
Study officials:
affiliation: NRG Oncology
name: Michael Gold
role: PRINCIPAL_INVESTIGATOR
References: