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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,010 Participants
are divided into 2 treatment groups
Group A: ObservationOther 1 intervention
Group B: Vaginal Brachytherapy (VBT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recurrence Free Survival (RFS)

The primary objective of this study is to evaluate if recurrence free survival (RFS) is non-inferior among women with stage I high-intermediate risk endometrial cancer who are ctDNA-negative after surgery and managed with ctDNA-guided observation versus adjuvant VBT.

Time frame
3 years from randomization to the first occurrence of disease recurrence or death from any cause, whichever occurs first

Secondary outcomes

1

Overall Survial

Comparison of overall survival (OS) among all high-intermediate risk (HIR) patients and recurrence free survival (RFS) across treatment groups and assess whether ctDNA-guided de-escalation group is non-inferior to adjuvant VBT.

Time frame
From enrollment to Year 3 and enrollment to Year 5
2

ctDNA Clearance Rate

Estimate the ctDNA clearance rate among high-intermediate risk ctDNA positive participants.

Time frame
From enrollment until first surveillance visit at 12 weeks
3

Clinicopathologic and Molecular Risk Factors

Assess the primary and secondary objectives by clinicopathologic and molecular (e.g. POLE, MMR-D, p53 aberrant, p53 wild type) risk factors, and ethnic/racial groups among high-intermediate risk patients.

Time frame
Up to 5 years from enrollment

Other outcomes

1

Lead time of ctDNA positivity

Examine differences in lead time of ctDNA positivity relative to clinical or radiologic diagnosis of recurrence across different ctDNA dynamic groups (e.g. clearance, persistent negative) among LR, HIR, and HR patients.

Time frame
Up to 5 years from enrollment
2

Disease-specific recurrence

Determine disease-specific recurrence among high-intermediate risk patients.

Time frame
At 3 years and 5 years.
3

ctDNA positivity rate

Assess ctDNA positivity rate, defined as proportion of patients, among all HIR, HR, and LR patients with evaluable ctDNA results

Time frame
From randomization to 3 years and 5 years
4

ctDNA negativity rate

ctDNA negativity rate, defined as proportion of patients with a negative ctDNA, among all HIR, HR, and LR patients with evaluable ctDNA results.

Time frame
From randomization to 3 years and 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Natera, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: