Circulating Tumor DNA Assessment in Early-Stage Endometrial Cancer (SIGNAL-EMC 101)
Natera, Inc.
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
Description
This includes a randomized, multi-center, non-inferiority trial for a biomarker-defined subgroup, alongside two parallel, non-randomized exploratory cohorts. The study utilizes a biomarker-stratified design to formally test a treatment de-escalation strategy in patients with HIR endometrial cancer. Following surgery, patients in the HIR cohort will be stratified based on post-operative circulating tumor DNA (ctDNA) status, as determined by the Signatera Genome assay. ctDNA-negative HIR Patients, based on the first valid post-operative ctDNA result within the baseline window, will be randomize…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: General inclusion criteria includes the following selection criteria to be eligible for inclusion in any aspect of the study. Eligibility will be assessed by the investigator: 1\. Signed and dated informed consent form (ICF) obtained prior to any trial-specific enrollment procedure. 2\. Patient is ≥ 18 years-old at the time of ICF signature. 3. Able to submit sufficient residual tissue obtained per standard of care procedures. HIR patients must meet all the following selection criteria to be eligible for the randomization cohort in the study. Eligibility will be assesse…
Interventions
- DeviceSignatera 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.
Locations (9)
- University of Alabama at Birmingham HospitalBirmingham, Alabama
- University of California, San DiegoLa Jolla, California
- University of California, Los AngelesLos Angeles, California
- University of MinnesotaMinneapolis, Minnesota
- New York UniversityNew York, New York
- Atrium Health Levine CancerCharlotte, North Carolina