Overview

This trial is active, not recruiting.

Conditions cervical adenocarcinoma, cervical adenosquamous carcinoma, cervical small cell carcinoma, cervical squamous cell carcinoma, stage ib cervical cancer, stage iia cervical cancer, stage iib cervical cancer, stage iii cervical cancer, stage iva cervical cancer
Treatments laboratory biomarker analysis, lymphadenectomy
Sponsor Gynecologic Oncology Group
Collaborator National Cancer Institute (NCI)
Start date April 2007
End date January 2100
Trial size 286 participants
Trial identifier NCT00460356, CDR0000540243, GOG-0221, NCI-2009-00592, U10CA027469, U10CA180868

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
laboratory biomarker analysis
Correlative studies
lymphadenectomy excision of the lymph node
Undergo lymphadenectomy

Primary Outcomes

Measure
Differences in 10 of the 300 carbohydrates under examination using the customized glycan array
time frame: Up to 3 years
Differences in approximately 50 of the 400 genes on the customized glycogene expression array
time frame: Up to 3 years
Level of immunohistochemical staining for Tn antigen and sialyl Tn antigen
time frame: Up to 3 years
Presence of T-synthase or Cosmc mutation
time frame: Up to 3 years

Secondary Outcomes

Measure
Local control
time frame: Up to 3 years
Lymph node metastasis
time frame: Up to 3 years
Overall survival
time frame: Up to 3 years
Progression-free survival (recurrence and disease progression)
time frame: Up to 3 years

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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
Principal investigator Michael Gold
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Gynecologic Oncology Group.