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 (Sentinel)

May 20, 2024 updated by: Strata Oncology

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

295

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Health Network
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study participants must meet all the inclusion criteria listed to enroll; 1. Male or female participants ≥ 18 years of age; 2. Confirmed diagnosis of a stage 1-3 solid tumor; 3. Curative surgery or definitive therapy (e.g., chemoradiation, stereotactic body radiation therapy [SBRT]) completed <5 years ago without any current evidence of radiographical or biochemical recurrence, or planned within 28 days of consent; 4. Surplus formalin fixed paraffin embedded tumor specimen available; 5. Able to tolerate venipuncture for blood draws; 6. Primary diagnosis is not glioma or CNS disease; 7. Both the tumor tissue sample and blood sample pass the quantity and quality parameters to allow for a successful MRD test result.

Description

Study participants must meet all the inclusion criteria below to enroll:

  1. Male or female participants ≥ 18 years of age;
  2. Confirmed diagnosis of a stage 1-3 solid tumor;
  3. Curative surgery or definitive therapy (e.g., chemoradiation, stereotactic body radiation therapy [SBRT]) completed <5 years ago without any current evidence of radiographical or biochemical recurrence, or planned within 28 days of consent;
  4. Surplus formalin fixed paraffin embedded tumor specimen available;
  5. Able to tolerate venipuncture for blood draws;
  6. Primary diagnosis is not glioma or CNS disease;
  7. Both the tumor tissue sample and blood sample pass the quantity and quality parameters to allow for a successful MRD test result.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity
Time Frame: 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.
8 years
ctDNA Response Rate
Time Frame: 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.
8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival (DFS): Duration of time between initiation of treatment and radiographic recurrence (investigator assessment) or death
Time Frame: 8 years
Determine the relationship between ctDNA response, clearance, and kinetics and radiographically determined disease-free survival and overall survival overall and as stratified by therapy class (targeted, immuno-, chemo-, etc.), individual therapy, tumor type, stage, and biomarker status.
8 years
Disease Free Survival (DFS): Duration of time between initiation of treatment and radiographic recurrence (investigator assessment) or death
Time Frame: 8 years
Determine the clinical benefit of therapy versus surveillance in ctDNA-positive participants as stratified by therapy class (targeted, immuno-, chemo-, etc.), individual therapy, tumor type, and biomarker status (DFS, OS). With Disease Free Survival (DFS) being the duration of time between initiation of treatment and radiographic recurrence (investigator assessment) or death and Overall survival (OS) being the duration of time between initiation of treatment and death.
8 years
Disease Free Survival (DFS): Duration of time between initiation of treatment and radiographic recurrence (investigator assessment) or death
Time Frame: 8 years
Determine the adjuvant therapy utilization rate stratified by ctDNA status, tumor type and tumor stage.
8 years

Other Outcome Measures

Outcome Measure
Time Frame
Examine the interaction of baseline tissue derived biomarkers identified by StrataMRD testing with ctDNA status and kinetics
Time Frame: 8 years
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Strata Oncology

Investigators

  • Study Director: Kat Kwiatkowski, PhD, Strata Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2021

Primary Completion (Actual)

October 2, 2023

Study Completion (Actual)

February 22, 2024

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 19, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STR-005-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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