Biomarkers in Tumor Tissue Samples From Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

This study is not yet open for participant recruitment.
Verified February 2014 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01164735
First received: July 16, 2010
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

This research study is studying biomarkers in tissue samples from patients with stage III, stage IV, or recurrent endometrial cancer. Studying samples of tumor tissue 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.


Condition Intervention
Recurrent Endometrial Carcinoma
Stage III Endometrial Carcinoma
Stage IV Endometrial Carcinoma
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Topoisomerase 2-Alpha (TOPO2A) Genomic Alterations And Immunohistochemical Expression as Well as Chromosome 17 Polysomy In Advanced or Recurrent Endometrial Carcinoma Treated With Anthracycline-Based Therapy

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From enrollment on GOG-0177 to death (regardless of cause) or to the date of last contact for women who were alive, assessed up to 5 years ] [ Designated as safety issue: No ]
    The Kaplan-Meier method will be used to estimate and plot the unadjusted survival and progression-free survival time distributions by TOPO2A expression and amplification status.


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: From enrollment on GOG-0177 to disease progression or death, or to the date of last contact for women who were still alive with no evidence of disease progression, assessed up to 5 years ] [ Designated as safety issue: No ]
    The Kaplan-Meier method will be used to estimate and plot the unadjusted survival and progression-free survival time distributions by TOPO2A expression and amplification status.

  • Clinical response (complete or partial response) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Logistic regression modeling will be used to explore the relationship between clinical response to treatment and both TOPO2A expression and amplification.


Estimated Enrollment: 169
Study Start Date: January 2100
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Correlative studies
Archived tumor tissue samples are analyzed for topoisomerase 2-alpha gene alteration and expression and chromosome 17 polysomy by FISH and IHC. Clinical information associated with each endometrial carcinoma sample (e.g., age, race/ethnicity, cell type, histologic grade, disease stage, and regimen type) is also collected.
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the frequency of topoisomerase 2-alpha (TOPO2A) gene copy number alterations (including deletions, gains, and amplification), immunohistochemical expression, and chromosome 17 polysomy in tumor tissue samples from patients with advanced or recurrent endometrial carcinoma treated with anthracycline-based therapy on Gynecologic Oncology Group (GOG)-0177.

II. To assess the relationship between TOPO2A gene copy number alterations, TOPO2A protein expression, chromosome 17 polysomy, and human epidermal growth factor receptor 2 (HER2) status in tumor tissue samples from these patients.

III. To assess the association between TOPO2A status (TOPO2A gene copy number alterations and TOPO2A protein expression), or chromosome 17 polysomy and clinical covariates (e.g., age, race/ethnicity, cell type, histologic grade, disease stage, regimen type).

IV. To assess the association between TOPO2A status or chromosome 17 polysomy with measures of clinical outcome including response, progression-free survival, and overall survival of patients treated with this regimen.

V. To evaluate the potential identification of cut points for TOPO2A protein expression with potential prognostic value in patients treated with this regimen.

OUTLINE:

Archived tumor tissue samples are analyzed for topoisomerase 2-alpha gene alteration and expression and chromosome 17 polysomy by fluorescent in situ hybridization (FISH) and immunohistochemistry (IHC). Clinical information associated with each endometrial carcinoma sample (e.g., age, race/ethnicity, cell type, histologic grade, disease stage, and regimen type) is also collected.

  Eligibility

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

Endometrial cancer archived tumor tissue

Criteria

Inclusion Criteria:

  • Chemotherapy-naïve women with histologically documented measurable Stage III, Stage IV or recurrent endometrial carcinoma with known HER2 status who participated in Gynecologic Oncology Group (GOG)-0177 are eligible
  • Patients must have given permission for their archival formalin-fixed, paraffin-embedded primary, metastatic or recurrent tumor to be submitted and used for GOG-0177, and at least one to three unstained slides must be available for FISH analysis of TOPO2A and CEP17 and immunohistochemical staining for TOPO2A

Exclusion Criteria:

  • Women who were not eligible or evaluable on GOG-0177
  • Patients who do not have at least one unstained slide archival formalin-fixed, paraffin-embedded primary, metastatic or recurrent tumor available for fluorescence in situ hybridization (FISH) analysis of TOPO2A and CEP17 or immunohistochemical expression of TOPO2A
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164735

Locations
United States, Pennsylvania
Gynecologic Oncology Group Not yet recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Tatyana A. Grushko    773-834-3518    tgrushko@medicine.bsd.uchicago.edu   
Principal Investigator: Tatyana A. Grushko         
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Tatyana Grushko Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01164735     History of Changes
Other Study ID Numbers: GOG-8013, NCI-2011-02245, CDR0000681556, GOG-8013, GOG-8013, GOG-8013, U10CA027469
Study First Received: July 16, 2010
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 17, 2014