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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


N/A
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer

Thank you

Trial Information

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


OBJECTIVES:

Primary

- 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

- 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.

- 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.

- 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.

- 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.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 286 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary invasive carcinoma of the cervix

- Any cell type

- Locoregionally advanced (stage IB2, IIA [tumor > 4 cm], IIB, III, or IVA) disease

- Previously untreated disease

- Undergoing a pelvic and para-aortic (abdominal) lymphadenectomy to determine the
presence or absence of lymph node metastasis

- Must have a block or 25 unstained sections of formalin-fixed and paraffin-embedded
primary tumor tissue available

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Presence of T-synthase or Cosmc mutation

Safety Issue:

No

Principal Investigator

Michael A. Gold, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oklahoma University Cancer Institute

Authority:

Unspecified

Study ID:

CDR0000540243

NCT ID:

NCT00460356

Start Date:

March 2007

Completion Date:

Related Keywords:

  • Cervical Cancer
  • stage IB cervical cancer
  • stage IIA cervical cancer
  • stage IIB cervical cancer
  • stage III cervical cancer
  • stage IVA cervical cancer
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • cervical small cell carcinoma
  • cervical squamous cell carcinoma
  • Uterine Cervical Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Women's Cancer Center - La CanadaLas Vegas, Nevada  89169