NCT01119573

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2010

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Last Updated

June 22, 2010

Status Verified

May 1, 2010

Enrollment Period

1 month

First QC Date

May 6, 2010

Last Update Submit

June 17, 2010

Conditions

Endometrial Cancer

Keywords

stage I endometrial carcinomastage III endometrial carcinoma

Outcome Measures

Primary Outcomes (1)

  • Association between microRNA expression and lymph node metastasis

Interventions

RNA analysisGENETIC
microarray analysisGENETIC
reverse transcriptase-polymerase chain reactionGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Microarray AnalysisReverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Microchip Analytical ProceduresInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification TechniquesGenetic Techniques

Study Officials

  • David S. Miller, MD

    Simmons Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NETWORK

Study Record Dates

First Submitted

May 6, 2010

First Posted

May 7, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2010

Last Updated

June 22, 2010

Record last verified: 2010-05