Glycoprotein and Glycan in Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer Undergoing Surgery to Remove Pelvic and Abdominal Lymph Nodes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00460356
First received: April 11, 2007
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

This clinical trial studies 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. 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.


Condition Intervention
Cervical Adenocarcinoma
Cervical Adenosquamous Cell 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
Other: laboratory biomarker analysis
Procedure: lymphadenectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Presence of T-synthase or Cosmc mutation [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Level of immunohistochemical staining for Tn antigen and sialyl Tn antigen [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Differences in approximately 50 of the 400 genes on the customized glycogene expression array [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Differences in 10 of the 300 carbohydrates under examination using the customized glycan array [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lymph node metastasis [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Local control [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival (recurrence and disease progression) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 286
Study Start Date: April 2007
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ancillary-Correlative (glycoprotein and glycan profiling)
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.
Other: laboratory biomarker analysis
Correlative studies
Procedure: lymphadenectomy
Undergo lymphadenectomy

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer Undergoing Surgery to Remove Pelvic and Abdominal Lymph Nodes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460356

Locations
United States, California
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States, 92868
Olive View-University of California Los Angeles Medical Center
Sylmar, California, United States, 91342
United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Michigan
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
United States, Mississippi
Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Saint Louis University Hospital
Saint Louis, Missouri, United States, 63110
United States, Nevada
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New York
Montefiore Medical Center-Einstein Campus
Bronx, New York, United States, 10461
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74146
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Michael Gold Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00460356     History of Changes
Other Study ID Numbers: GOG-0221, NCI-2009-00592, CDR0000540243, GOG-0221, GOG-0221, U10CA027469
Study First Received: April 11, 2007
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Carcinoma, Adenosquamous
Carcinoma, Small Cell
Carcinoma, Squamous Cell
Small Cell Lung Carcinoma
Uterine Cervical Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Genital Diseases, Female
Genital Neoplasms, Female
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Krestin
Adjuvants, Immunologic
Anti-Infective Agents
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on October 29, 2014