Clinical Trial

Signatera Assessment in Early-Stage Endometrial Cancer

Study acronym: SIGNAL-EMC 101
Not Yet Recruiting
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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
Protocol Amendment History 4 changes
notable Trial sites expanded: 9 -> 12 locations 2026-06-18
notable Primary completion pushed: 2034-05 -> 2034-10 2026-06-18
minor Completion pushed: 2034-05 -> 2034-10 2026-06-18
notable Trial sites expanded: 0 -> 9 locations 2026-04-23
Trial Details
NCT Number NCT07339384
Lead Sponsor Natera, Inc.
Conditions Endometrial Cancer
Enrollment 1,010 participants
Start Date 2026-10
Primary Completion 2034-10 (estimated)
Study Completion 2034-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-17