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

NCT ID: NCT05082701

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 295 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-03
• Study Completion Date: 2024-02-22

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.

Conditions

Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Strata Oncology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kat Kwiatkowski, PhD

Role: STUDY_DIRECTOR

Strata Oncology

Locations

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

University of Michigan

Ann Arbor, Michigan, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

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Other Identifiers

STR-005-001

Identifier Type: -

Identifier Source: org_study_id