Status:

COMPLETED

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

Lead Sponsor:

Gynecologic Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Recurrent Uterine Corpus Carcinoma

Stage III Uterine Corpus Cancer

Eligibility:

FEMALE

18+ years

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 ...

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 c...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 1 2018

Estimated Enrollment :

169 Patients enrolled

Trial Details

Trial ID

NCT01164735

Start Date

January 1 2010

End Date

January 1 2018

Last Update

August 14 2024

Active Locations (1)

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Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States, 19103