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 2026-05
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 range18 Years
SexFEMALE
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)
✓. 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
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
✕. 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.