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

NCT01164735 | Completed

• 4 other identifiers: GOG-8013NCI-2011-02245CDR0000681556U10CA027469
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 1

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 laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Conditions

Recurrent Uterine Corpus Carcinoma; Stage III Uterine Corpus Cancer; Stage IV Uterine Corpus Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  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.

  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

Secondary Outcomes (2)

• Clinical response (complete or partial response)

  Up to 5 years

• Progression-free survival

  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

Study Arms (1)

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.

Other: Laboratory Biomarker Analysis

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Correlative studies

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (1)

• Grushko TA, Filiaci VL, Montag AG, Apushkin M, Gomez MJ, Monovich L, Ramirez NC, Schwab C, Kesterson JP, Seward SM, Method MW, Olopade OI, Fleming GF, Birrer MJ. Effects of Slide Storage on Detection of Molecular Markers by IHC and FISH in Endometrial Cancer Tissues From a Clinical Trial: An NRG Oncology/GOG Pilot Study. Appl Immunohistochem Mol Morphol. 2022 Jan 1;30(1):27-35. doi: 10.1097/PAI.0000000000000949.

  PMID: 34224438 DERIVED

Study Officials

• Tatyana Grushko

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 19, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

US (1)