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
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Condition or disease | Intervention/treatment |
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Recurrent Uterine Corpus Carcinoma Stage III Uterine Corpus Cancer Stage IV Uterine Corpus Cancer | Other: Laboratory Biomarker Analysis |
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 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 |
Group/Cohort | Intervention/treatment |
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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.
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Other: Laboratory Biomarker Analysis
Correlative studies |
- 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.
- 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.
- 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.
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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 |
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
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
United States, Pennsylvania | |
Gynecologic Oncology Group | |
Philadelphia, Pennsylvania, United States, 19103 |
Principal Investigator: | Tatyana Grushko | Gynecologic Oncology Group |
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 |
Carcinoma Recurrence Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Disease Attributes Pathologic Processes |