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Signatera Assessment in Early-Stage Endometrial Cancer
Sponsor: Natera, Inc.
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
Conditions
Interventions
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