Clinical trial NCT05082701: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Lead sponsor: Strata Oncology
Sponsor class: INDUSTRY
First posted: 2021-10-19
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: 8 years
measure: ctDNA Response Rate
timeFrame: 8 years
Secondary outcomes:
measure: Disease Free Survival (DFS): Duration of time between initiation of treatment and radiographic recurrence (investigator assessment) or death
timeFrame: 8 years
measure: Disease Free Survival (DFS): Duration of time between initiation of treatment and radiographic recurrence (investigator assessment) or death
timeFrame: 8 years
measure: Disease Free Survival (DFS): Duration of time between initiation of treatment and radiographic recurrence (investigator assessment) or death
timeFrame: 8 years
Other outcomes:
measure: Examine the interaction of baseline tissue derived biomarkers identified by StrataMRD testing with ctDNA status and kinetics
timeFrame: 8 years
Locations:
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Strata Oncology
name: Kat Kwiatkowski, PhD
role: STUDY_DIRECTOR
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