Signatera Assessment in Early-Stage Endometrial Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Natera, Inc.
Study ID
NCT07339384
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Signatera Genome ultra-sensitive ctDNA blood test — DEVICE
    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.

Study Details

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

Key Dates

Start date
May 31, 2026
Status verified
Jan 2026
Primary completion
May 31, 2034
Completion
May 31, 2034

Study Design

Enrollment
1,010 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Observation
    Participants will be monitored by their study physician and will not receive treatment
  • Active Comparator: Vaginal Brachytherapy (VBT)
    Participants will receive standard-of-care vaginal brachytherapy

Primary Outcome Measure

Recurrence Free Survival (RFS) [ Time Frame: 3 years from randomization to the first occurrence of disease recurrence or death from any cause, whichever occurs first ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham HospitalBirminghamAlabama35294
Michael Toboni, MD (PRINCIPAL_INVESTIGATOR)
University of California, San DiegoLa JollaCalifornia92093
Ramez Eskander, MD (PRINCIPAL_INVESTIGATOR)
University of California, Los AngelesLos AngelesCalifornia90095
Dana Chase, MD (PRINCIPAL_INVESTIGATOR)
University of MinnesotaMinneapolisMinnesota55455
Melissa Geller, MD (PRINCIPAL_INVESTIGATOR)
New York UniversityNew YorkNew York10016
Bhavana Pothuri, MD (PRINCIPAL_INVESTIGATOR)
Atrium Health Levine CancerCharlotteNorth Carolina28204
Allison Puechl, MD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27708
Angeles Secord, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44106
Kevin Elias, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Wexner Medical CenterColumbusOhio43210
Floor Backes, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Alabama at Birmingham Hospital· Birmingham, ALUniversity of California, San Diego· La Jolla, CAUniversity of California, Los Angeles· Los Angeles, CAUniversity of Minnesota· Minneapolis, MNNew York University· New York, NYAtrium Health Levine Cancer· Charlotte, NC

Related Studies