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

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ClinicalTrials.gov Identifier: NCT01164735
Recruitment Status : Not yet recruiting
First Posted : July 19, 2010
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation ( Gynecologic Oncology Group )

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Recurrent Uterine Corpus Carcinoma Stage III Uterine Corpus Cancer Stage IV Uterine Corpus Cancer Other: Laboratory Biomarker Analysis

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 169 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Study Start Date : January 2100
Estimated Primary Completion Date : January 2100
Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Clinical response (complete or partial response) [ Time Frame: Up to 5 years ]
    Logistic regression modeling will be used to explore the relationship between clinical response to treatment and both TOPO2A expression and amplification.

  2. 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 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Stage III, Stage IV, or recurrent endometrial cancer
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164735


Locations
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United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Tatyana Grushko Gynecologic Oncology Group
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01164735    
Other Study ID Numbers: GOG-8013
NCI-2011-02245 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000681556
GOG-8013
GOG-8013 ( Other Identifier: Gynecologic Oncology Group )
GOG-8013 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2010    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Carcinoma
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Disease Attributes
Pathologic Processes