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. (see Contacts and Locations)
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

July 16, 2010
February 26, 2014
January 2100
January 2100   (final data collection date for primary outcome measure)
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.
Overall survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01164735 on ClinicalTrials.gov Archive Site
  • 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.
  • Progression-free survival [ Designated as safety issue: No ]
  • Clinical response (complete or partial response) [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Biomarkers in Tumor Tissue Samples From Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
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

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Endometrial cancer archived tumor tissue

  • Recurrent Endometrial Carcinoma
  • Stage III Endometrial Carcinoma
  • Stage IV Endometrial Carcinoma
Other: laboratory biomarker analysis
Correlative studies
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.
Intervention: Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
169
Not Provided
January 2100   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
United States
 
NCT01164735
GOG-8013, NCI-2011-02245, CDR0000681556, GOG-8013, GOG-8013, GOG-8013, U10CA027469
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Tatyana Grushko Gynecologic Oncology Group
Gynecologic Oncology Group
February 2014

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