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Signatera Assessment in Early-Stage Endometrial Cancer

NCT07339384 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1010

Last updated 2026-04-22

No results posted yet for this study

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

Conditions

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.

Sponsors & Collaborators

  • Natera, Inc.

    lead INDUSTRY

Principal Investigators

  • Adam ElNaggar, MD · Natera, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2034-05-31
Completion
2034-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07339384 on ClinicalTrials.gov