Biomarkers in Tumor Tissue Samples From Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by National Cancer Institute (NCI).
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01164735
First received: July 16, 2010
Last updated: September 25, 2010
Last verified: July 2010
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Purpose
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in tissue samples from patients with stage III, stage IV, or recurrent endometrial cancer.
| Condition | Intervention |
|---|---|
|
Endometrial Cancer |
Genetic: fluorescence in situ hybridization Genetic: gene expression analysis Genetic: mutation analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: medical chart review |
| Study Type: | Observational |
| 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 National Cancer Institute (NCI):
Primary Outcome Measures:
- Overall survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival [ Designated as safety issue: No ]
- Clinical response (complete or partial response) [ Designated as safety issue: No ]
| Estimated Enrollment: | 162 |
| Study Start Date: | January 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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 GOG-0177.
- To assess the relationship between TOPO2A gene copy number alterations, TOPO2A protein expression, chromosome 17 polysomy, and HER2 status in tumor tissue samples from these patients.
- 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).
- 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.
- To evaluate the potential identification of cut points for TOPO2A protein expression with potential prognostic value in patients treated with this regimen.
OUTLINE: This is a multicenter study.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed endometrial carcinoma
- Stage III, IV, or recurrent disease
Patients who participated on GOG-0177 and allowed their specimens and clinical data (covariance) collected as part of their participation
- 1-3 slides of archived formalin-fixed or paraffin-embedded primary tumor tissue available
- Treated with anthracycline-based therapy
PATIENT CHARACTERISTICS:
- GOG performance status 0-2
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01164735 History of Changes |
| Other Study ID Numbers: | CDR0000681556, GOG-8013 |
| Study First Received: | July 16, 2010 |
| Last Updated: | September 25, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
recurrent endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms |
Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on June 18, 2013