Prognostic Biomarkers in Patients With Endometrial Cancer

Gynecologic Oncology Group (GOG)

Status: Completed

Conditions: Stage I Uterine Corpus Cancer; Endometrial Adenocarcinoma; Stage IV Uterine Corpus Cancer; Stage II Uterine Corpus Cancer; Recurrent Uterine Corpus Carcinoma; Stage III Uterine Corpus Cancer

Treatments: Other: Laboratory Biomarker Analysis

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01208467

GOG-8017

U10CA027469 (U.S. NIH Grant/Contract)

NCI-2011-02870 (Registry Identifier)

CDR0000685834

Details and patient eligibility

About

This research study is studying prognostic biomarkers in tissue samples from patients with endometrial cancer. Studying samples of 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.

Full description

PRIMARY OBJECTIVES:

I. To validate the clinicopathologic associations and prognostic significance of ATR mutation in endometrioid endometrial cancer cases with defective DNA mismatch repair.

OUTLINE: This is a multicenter study.

DNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation.

Enrollment: 2,824 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Women who were eligible and evaluable for the GOG-0210 molecular staging protocol in women with endometrial cancer

  • Women who were registered during the unrestricted enrollment period (through 9/23/07) will automatically qualify
  • Women who were registered during the restricted enrollment period (after 9/23/07) will only be considered if needed

• Women who had histologically confirmed endometrioid endometrial adenocarcinoma regardless of stage or grade

• Women who have defective DNA mismatch repair and are microsatellite instability positive (MSI+ and MSI-low)

• Women who consented to allow their specimens and clinical data to be used for future cancer research

• Women who have sufficient high-quality genomic DNA from tumor available for mutation analysis of ATR

Trial design

2,824 participants in 1 patient group

Basic science (DNA analysis)

Description:

DNA extracted from previously collected tumor samples is analyzed to validate the clinicopathologic associations and prognostic significance of ATR mutation.

Treatment:

Other: Laboratory Biomarker Analysis