Signatera Test for Endometrial Cancer
(SIGNAL-EMC 101 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates a DNA test called Signatera to determine its effectiveness in guiding follow-up treatment for early-stage endometrial cancer after surgery. The researchers aim to discover if some women can avoid radiation therapy when their DNA test shows no cancer DNA. Women diagnosed with Stage I endometrial cancer who have undergone surgery might be suitable candidates. Participants will either receive regular DNA tests and doctor visits or undergo standard internal radiation therapy, allowing researchers to compare outcomes. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could personalize and enhance future cancer treatments.
What prior data suggests that the Signatera test is safe for guiding adjuvant selection in endometrial cancer?
Research has shown that Signatera, a personalized blood test, can help detect cancer recurrence by identifying changes in specific DNA fragments in the blood. Studies have examined its safety and effectiveness, particularly in assessing the risk of endometrial cancer returning. It has also been used for other cancers, such as uterine cancer, where it detected recurrences before they appeared on scans.
While these studies focus on Signatera's effectiveness, they have not reported any major safety issues. As a blood test, it is generally safe and poses fewer risks compared to treatments like drugs or surgeries. There are no reports of serious side effects from the test itself. However, discussing any concerns with a doctor is important to understand what this means for individual cases.12345Why are researchers excited about this trial?
Most treatments for endometrial cancer, like surgery or radiation therapy, focus on removing or destroying cancer cells. But the Signatera test is unique because it is a personalized diagnostic tool that can detect molecular residual disease (MRD) by analyzing tumor DNA in the blood. This approach allows for highly precise monitoring of cancer recurrence, which can lead to earlier intervention if needed. Researchers are excited because this test has the potential to improve how we track and treat endometrial cancer, moving towards more customized and timely care for patients.
What evidence suggests that the Signatera test is effective for guiding adjuvant selection in endometrial cancer?
Research has shown that the Signatera test effectively detects endometrial cancer recurrence. Studies found it identified 100% of uterine cancer recurrences before they appeared on scans, providing an average of 3.1 months' notice. Patients with residual cancer detected by Signatera after treatment were more likely to experience a recurrence. This test can identify returning cancer earlier than regular scans and blood tests. Its early predictive ability makes it a promising tool for managing endometrial cancer. Participants in this trial will either be monitored through observation or receive standard-of-care vaginal brachytherapy (VBT).23456
Who Is on the Research Team?
Adam ElNaggar, MD
Principal Investigator
Natera, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline and Randomization
Post-operative ctDNA status is assessed to stratify patients into different arms
Treatment
Participants receive either observation or vaginal brachytherapy based on randomization
Follow-up
Participants are monitored for recurrence-free survival and overall survival
Long-term Surveillance
Continued monitoring of ctDNA status and quality of life outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Signatera
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will be monitored by their study physician and will not receive treatment
Participants will receive standard-of-care vaginal brachytherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Natera, Inc.
Lead Sponsor
Citations
Signatera Assessment in Early-Stage Endometrial Cancer
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.
2.
investor.natera.com
investor.natera.com/news/news-details/2025/Signatera-Surveillance-Testing-Identified-100-of-Uterine-Cancer-Recurrences-in-Advance-of-Imaging-New-Study-Shows/default.aspxSignatera™ Surveillance Testing Identified 100% of ...
“Signatera consistently identified early-stage uterine cancer patients at high risk of recurrence, and predicted recurrences prior to clinical ...
New Study Validates Signatera™ in Endometrial Cancer
Patients who tested Signatera MRD-positive at either a single time point or longitudinally experienced significantly higher rates of recurrence ...
Post-surgical ctDNA-based molecular residual disease ...
This study included 101 patients diagnosed with stage I uterine malignancies (88% EC) who underwent testing using a tumor-informed ctDNA assay, Signatera™, from ...
5.
news.cancerconnect.com
news.cancerconnect.com/blood-test-helps-detect-uterine-cancer-recurrence-earlier-than-scans/Blood Test Helps Detect Uterine Cancer Recurrence Earlier ...
A new study shows that Signatera™, a personalized blood test, detected every case of uterine cancer recurrence before it was found on imaging ...
6.
natera.com
natera.com/oncology/signatera-advanced-cancer-detection/patients/signatera-for-gynecologic-cancers/Signatera for Gynecologic Cancers
Repeated Signatera™ testing can show changes in your ctDNA levels, helping your doctor understand if your cancer is shrinking, growing, coming back, or ...
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