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

April 11, 2007
August 8, 2014
April 2007
January 2100   (final data collection date for primary outcome measure)
  • 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 ]
  • Presence of T-synthase or Cosmc mutation
  • Level of immunohistochemical staining for Tn antigen and sialyl Tn antigen
  • Differences in approximately 50 of the 400 genes on the customized glycogene expression array
  • Differences in 10 of the 300 carbohydrates under examination using the customized glycan array
Complete list of historical versions of study NCT00460356 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Lymph node metastasis
  • Local control
  • Progression-free survival (recurrence and disease progression)
  • Overall survival
Not Provided
Not Provided
 
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
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

  • 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
    Correlative studies
  • Procedure: lymphadenectomy
    Undergo lymphadenectomy
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.
Interventions:
  • Other: laboratory biomarker analysis
  • Procedure: lymphadenectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
286
Not Provided
January 2100   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00460356
GOG-0221, NCI-2009-00592, CDR0000540243, GOG-0221, GOG-0221, U10CA027469
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Michael Gold Gynecologic Oncology Group
Gynecologic Oncology Group
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP