Biomarkers in Tissue Samples From Patients With Stage I or Stage III Endometrial Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 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:
NCT01119573
First received: May 6, 2010
Last updated: June 17, 2010
Last verified: May 2010
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Purpose
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is studying at biomarkers in tissue samples from patients with stage I or stage III endometrial cancer.
| Condition | Intervention |
|---|---|
|
Endometrial Cancer |
Genetic: RNA analysis Genetic: microarray analysis Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Micro RNA's Associated With Lymph Node Metastasis in Endometrial Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Association between microRNA expression and lymph node metastasis [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To identify microRNA expression patterns associated with lymph node metastasis in samples from patients with endometrial cancer.
OUTLINE: Banked tumor tissue specimens are analyzed for microRNA expression profiling by microarray analysis and reverse transcriptase-PCR assays.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed endometrioid endometrial cancer
- Stage IA, IB, IC, or IIIC disease
- Any grade
Enrolled and evaluated on GOG-0210 Molecular Staging Study of Endometrial Cancer
- Consented to allow their specimens and clinical data to be collected and stored for future research
Underwent complete surgical staging, including the following:
- Hysterectomy
- Bilateral oophorectomy
- Washings as well as pelvic lymphadenectomy (sampling of four left and four right pelvic lymph nodes)
- Para-aortic lymphadenectomy (sampling of one left and one right para-aortic lymph node)
- Sufficient high-quality frozen primary tumor for testing with ≥ 75% tumor cellularity and ≤ 10% necrosis
PATIENT CHARACTERISTICS:
- Not specified
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: | NCT01119573 History of Changes |
| Other Study ID Numbers: | CDR0000672415, GOG-8014 |
| Study First Received: | May 6, 2010 |
| Last Updated: | June 17, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage I endometrial carcinoma stage III 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