Signatera Assessment in Early-Stage Endometrial Cancer (NCT07339384) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Signatera Assessment in Early-Stage Endometrial Cancer
United States1,010 participantsStarted 2026-10
Plain-language 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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. FIGO 2009 Stage I after hysterectomy and lymph node assessment by bilateral pelvic lymphadenectomy or SLND
. If para-aortic lymph nodes are not pathologically assessed, documentation of surgical assessment or imaging is recommended.
. Stage I patients with endometrioid histology:
. Age 70 years or older with one uterine risk factor,
. Age 50-69 years with two risk factors,
. Age 18 - 49 years with three risk factors.
. Negative peritoneal cytology, where performed (recommended)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on early-stage endometrial cancer and uses something called Signatera to monitor for recurrence — can you explain what Signatera is, how it works as a blood test, and whether it might give us earlier warning of cancer coming back compared to what we'd normally use?
2The trial is measuring 'recurrence free survival' as its main goal — what does that mean in practical terms for how I'd be followed and monitored if I joined, and how often would I need to come in for testing?
3Since this trial is listed as 'not yet recruiting,' how soon do you think it might open, and is there any reason I should wait to see if I can enroll, or would it be better for me to start standard follow-up care now?
4This study doesn't have a traditional phase listed, which makes me think it might be more of an observational or monitoring study rather than one testing a new drug — can you help me understand what participating would actually involve and whether it changes my treatment at all?
5If this trial turns out not to be a good fit for me, are there other ways I could access this kind of molecular residual disease testing outside of a clinical trial, or is Signatera something that's already available as part of routine care for early-stage endometrial cancer?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recurrence Free Survival (RFS)
Timeframe: 3 years from randomization to the first occurrence of disease recurrence or death from any cause, whichever occurs first
. If para-aortic lymph nodes are not pathologically assessed, imaging is required b. FIGO 2009 Stage II Endometrioid
Exclusion criteria
. Undifferentiated or dedifferentiated histology
. Uterine sarcoma
. Prior pelvic radiation therapy
. Positive pelvic washings
. Pelvic lymph node assessment was not performed
. Isolated Tumor Cells (ITC) identified in the lymph node(s)
. Prior therapy for endometrial cancer (including hormonal therapy, chemotherapy, targeted therapy, immunotherapy)
. Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of active malignancy within the last five years.