Signatera Assessment in Early-Stage Endometrial Cancer
ConditionEndometrial Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNatera, Inc.
About this trial
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
Eligibility criteria
Qualifiers
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.
Age 70 years or older with one uterine risk factor,
Age 50-69 years with two risk factors,
Disqualifiers
Undifferentiated or dedifferentiated histology
Uterine sarcoma
Prior pelvic radiation therapy
Positive pelvic washings
Trial design
Treatments tested in this trial
- Signatera Genome ultra-sensitive ctDNA blood test
Treatment groups
1,010 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov