Sentinel™ Trial: A Prospective Study Evaluating the Performance and Clinical Benefit of Personalized ctDNA-based MRD Testing to Detect Recurrence and Monitor Treatment Response in Patients With Solid Tumors

Terminated

• Conditions: Cancer

• Registration Number: NCT05082701
• Lead Sponsor: Strata Oncology

Brief Summary

The Sentinel™ Trial is a non-randomized, large-scale observational trial designed to: 1) evaluate the ability of circulating tumor DNA (ctDNA)-based minimal residual disease (MRD) testing to detect recurrence in advance of standard-of-care techniques across solid tumors, and 2) determine the clinical benefit of therapy in ctDNA-positive participants.

The study offers the opportunity to 1) serially monitor participants for ctDNA changes, 2) define ctDNA kinetics across tumor and therapy types, 3) identify participants with ctDNA evidence of MRD, and 4) understand the clinical benefit of ctDNA status on treatment outcomes.

Detailed Description

Patients with a confirmed diagnosis of a stage I through III solid tumor who have had definitive therapy or curative surgery within the last 5 years or are planning curative surgery may be eligible for the Sentinel Trial. Patients must have a surplus formalin-fixed paraffin-embedded tumor specimen available at screening, or a planned resection within 28 days of screening. To support ctDNA assessment, study procedures will be limited to serial blood draws repeated every 12 weeks until investigator determined recurrence. Upon recurrence, participants will remain on study for 3 years in survival follow-up.

Study Timeline

• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-19
• Study Start: 2021-12-03
• Primary Completion: 2023-10-02
• Study Completion: 2024-02-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 295

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ctDNA Response Rate	8 years	Determine the clinical benefit of treatment in ctDNA-positive participants, as stratified by therapy class (targeted, immuno-, chemo-, etc.), individual therapy, tumor type, stage, and biomarker status. With ctDNA response rate being the proportion of participants with \>50% reduction in mean variant allele frequency (VAF) on-treatment at 3 months compared to baseline VAF.
Sensitivity and Specificity	8 years	Evaluate ability of ctDNA-based MRD monitoring to detect disease recurrence in advance of SOC recurrence monitoring across solid tumors, as stratified by tumor type and adjuvant therapy status. With sensitivity being the proportion of participants with radiographic recurrence who first had a ctDNA recurrence and specificity being the proportion of participants without radiographic recurrence who did not first have a ctDNA recurrence.

Secondary Outcome Measures

Name	Time	Method
Disease Free Survival (DFS): Duration of time between initiation of treatment and radiographic recurrence (investigator assessment) or death	8 years	Determine the adjuvant therapy utilization rate stratified by ctDNA status, tumor type and tumor stage.

Trial Locations

Locations (4)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Lehigh Valley Health Network; 🇺🇸 Allentown, Pennsylvania, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States