Signatera Assessment in Early-Stage Endometrial Cancer

This study is looking at whether a blood test called Signatera Genome can help guide treatment for women with early-stage endometrial cancer (cancer of the lining of the uterus) that is considered high-intermediate risk. The study wants to see if women who are found to be "ctDNA negative" (meaning no circulating tumor DNA is detected in their blood after surgery) can safely choose observation instead of vaginal brachytherapy (a type of internal radiation therapy). Researchers will compare the recurrence-free survival (how long patients live without their cancer coming back) at 3 years for women who are observed versus those who receive vaginal brachytherapy. You may be able to join if you are a woman aged 18 or older with early-stage, high-intermediate risk endometrial cancer. The current recruitment status is unclear.

Study design
This is a randomized study with 1010 planned participants. It compares two groups of patients to see if one treatment approach is as good as another.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your recurrence-free survival will be measured for 3 years from the start of the study.

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NCT07339384

Signatera Assessment in Early-Stage Endometrial Cancer

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Natera, Inc.
~1,010 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Signatera Genome ultra-sensitive ctDNA blood test

At a glance

Recruiting sites
0 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence Free Survival (RFS)
Measured over 3 years from randomization to the first occurrence of disease recurrence or death from any cause, whichever occurs first
Endometrial Cancer
12 sites across 9 states
California2
North Carolina2
Ohio2
Alabama1
Florida1
Illinois1
Minnesota1
New York1
  • Adam ElNaggar, MD · STUDY_DIRECTOR · Natera, Inc.

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Eligibility criteria

Inclusion

Grade 2 or 3 tumor.
Outer half depth of invasion.
Lymphovascular invasion. Note: peritoneal cytology must be negative if performed.
  • Recurrence Free Survival (RFS)3 years from randomization to the first occurrence of disease recurrence or death from any cause, whichever occurs first

    The primary objective of this study is to evaluate if recurrence free survival (RFS) is non-inferior among women with stage I high-intermediate risk endometrial cancer who are ctDNA-negative after surgery and managed with ctDNA-guided observation versus adjuvant VBT.