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NOT YET RECRUITING
NCT07339384
NA

Signatera Assessment in Early-Stage Endometrial Cancer

Sponsor: Natera, Inc.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to assess if circulating tumor DNA can guide adjuvant selection in high-intermediate risk early-stage endometrial cancer. The main question it aims to answer is: • To evaluate if 3-year recurrence-free survival among women with Stage I, high-intermediate risk endometrial cancer who are ctDNA negative after receiving ctDNA-guided observation is non-inferior to adjuvant vaginal brachytherapy (an internal radiation therapy) Researchers will compare high-risk intermediate ctDNA negative participants who are observed to those who receive vaginal brachytherapy to see if they have similar outcomes. Participants will be asked to: * Receive serial ctDNA testing * Visit their study doctor per their standard of care visits about every 3 months for 2 years * Answer a questionnaire about their well-being

Official title: Circulating Tumor DNA Assessment in Early-Stage Endometrial Cancer (SIGNAL-EMC 101)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1010

Start Date

2026-05

Completion Date

2034-05

Last Updated

2026-04-22

Healthy Volunteers

No

Interventions

DEVICE

Signatera Genome ultra-sensitive ctDNA blood test

Signatera Genome is intended for use as a post-surgical risk stratification tool for patients with early-stage HIR endometrial cancer. The test is used to identify patients with no evidence of MRD following definitive surgery.

Locations (9)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, United States

University of California, San Diego

La Jolla, California, United States

University of California, Los Angeles

Los Angeles, California, United States

University of Minnesota

Minneapolis, Minnesota, United States

New York University

New York, New York, United States

Atrium Health Levine Cancer

Charlotte, North Carolina, United States

Duke University

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States