CancerSentinelNCT05082701

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

An observational study of Cancer, run by Strata Oncology at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer
How many people: 295 participants
Where: 4 sitesUnited States
Study dates: 3 Dec 2021to 22 Feb 2024
How long will I take part?: 8 Years
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

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

Male or female participants ≥ 18 years of age;
Confirmed diagnosis of a stage 1-3 solid tumor;
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;
Surplus formalin fixed paraffin embedded tumor specimen available;
Able to tolerate venipuncture for blood draws;
Primary diagnosis is not glioma or CNS disease;
Both the tumor tissue sample and blood sample pass the quantity and quality parameters to allow for a successful MRD test result.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

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

Other trials in United States

About this study

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.

Read the 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
Medical subject headings: Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity and Specificity
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.
Measured: 8 years
ctDNA Response Rate
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.
Measured: 8 years

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Dec 202122 Feb 2024

First posted19 Oct 2021
Study start3 Dec 2021
Primary completion2 Oct 2023
Study completion22 Feb 2024

Why it stopped: Sentinel MRD test offers no additional or increased benefits to patients compared to current marketed alternatives

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 295 participants (actual)
Target duration: 8 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT05082701
Sponsor's protocol ID: STR-005-001
Acronym: Sentinel
Status last verified: May 2024
First submitted: 9 Sep 2021
Last updated: 22 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338
Miller KD, Nogueira L, Mariotto AB, Rowland JH, Yabroff KR, Alfano CM, Jemal A, Kramer JL, Siegel RL. Cancer treatment and survivorship statistics, 2019. CA Cancer J Clin. 2019 Sep;69(5):363-385. doi: 10.3322/caac.21565. Epub 2019 Jun 11.
PubMed 31184787
Bockelman C, Engelmann BE, Kaprio T, Hansen TF, Glimelius B. Risk of recurrence in patients with colon cancer stage II and III: a systematic review and meta-analysis of recent literature. Acta Oncol. 2015 Jan;54(1):5-16. doi: 10.3109/0284186X.2014.975839. Epub 2014 Nov 28.
PubMed 25430983
Reinert T, Henriksen TV, Christensen E, Sharma S, Salari R, Sethi H, Knudsen M, Nordentoft I, Wu HT, Tin AS, Heilskov Rasmussen M, Vang S, Shchegrova S, Frydendahl Boll Johansen A, Srinivasan R, Assaf Z, Balcioglu M, Olson A, Dashner S, Hafez D, Navarro S, Goel S, Rabinowitz M, Billings P, Sigurjonsson S, Dyrskjot L, Swenerton R, Aleshin A, Laurberg S, Husted Madsen A, Kannerup AS, Stribolt K, Palmelund Krag S, Iversen LH, Gotschalck Sunesen K, Lin CJ, Zimmermann BG, Lindbjerg Andersen C. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019 Aug 1;5(8):1124-1131. doi: 10.1001/jamaoncol.2019.0528.
PubMed 31070691
Coombes RC, Page K, Salari R, Hastings RK, Armstrong A, Ahmed S, Ali S, Cleator S, Kenny L, Stebbing J, Rutherford M, Sethi H, Boydell A, Swenerton R, Fernandez-Garcia D, Gleason KLT, Goddard K, Guttery DS, Assaf ZJ, Wu HT, Natarajan P, Moore DA, Primrose L, Dashner S, Tin AS, Balcioglu M, Srinivasan R, Shchegrova SV, Olson A, Hafez D, Billings P, Aleshin A, Rehman F, Toghill BJ, Hills A, Louie MC, Lin CJ, Zimmermann BG, Shaw JA. Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence. Clin Cancer Res. 2019 Jul 15;25(14):4255-4263. doi: 10.1158/1078-0432.CCR-18-3663. Epub 2019 Apr 16.
PubMed 30992300
Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS; ADAURA Investigators. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Oct 29;383(18):1711-1723. doi: 10.1056/NEJMoa2027071. Epub 2020 Sep 19.
PubMed 32955177
Vidal J, Casadevall D, Bellosillo B, Pericay C, Garcia-Carbonero R, Losa F, Layos L, Alonso V, Capdevila J, Gallego J, Vera R, Salud A, Martin-Richard M, Nogue M, Cillan E, Maurel J, Faull I, Raymond V, Fernandez-Martos C, Montagut C. Clinical Impact of Presurgery Circulating Tumor DNA after Total Neoadjuvant Treatment in Locally Advanced Rectal Cancer: A Biomarker Study from the GEMCAD 1402 Trial. Clin Cancer Res. 2021 May 15;27(10):2890-2898. doi: 10.1158/1078-0432.CCR-20-4769. Epub 2021 Mar 16.
PubMed 33727257
Powels, T.B. et al., Clinical outcomes in post-operative ctDNA-positive muscle-invasive urothelial carcinoma (MIUC) patients after atezolizumab adjuvant therapy. Annals of Oncology, 2020. 31(suppl_7): S1417-S1424.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05082701
Acronym / sponsor ID: Sentinel / STR-005-001
Conditions: Cancer
Study type: Observational
Recruitment status: TerminatedReason stopped: Sentinel MRD test offers no additional or increased benefits to patients compared to current marketed alternatives
Enrolment: 295 participants (actual)
Lead sponsor: Strata OncologyIndustry (pharma, biotech, devices)
Study start: 3 Dec 2021 (actual)
Primary completion: 2 Oct 2023 (actual)
Study completion: 22 Feb 2024 (actual)
First posted: 19 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 8 Years

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
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.

3 secondary outcomes

Disease Free Survival (DFS): Duration of time between initiation of treatment and radiographic recurrence (investigator assessment) or death
Time frame: 8 years
Disease Free Survival (DFS): Duration of time between initiation of treatment and radiographic recurrence (investigator assessment) or death
Time frame: 8 years
Disease Free Survival (DFS): Duration of time between initiation of treatment and radiographic recurrence (investigator assessment) or death
Time frame: 8 years

Results and safety

The study was stopped early (reason given: Sentinel MRD test offers no additional or increased benefits to patients compared to current marketed alternatives). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
Background: PubMed 31184787Miller KD, Nogueira L, Mariotto AB, Rowland JH, Yabroff KR, Alfano CM, Jemal A, Kramer JL, Siegel RL. Cancer treatment and survivorship statistics, 2019. CA Cancer J Clin. 2019 Sep;69(5):363-385. doi: 10.3322/caac.21565. Epub 2019 Jun 11.
Background: PubMed 25430983Bockelman C, Engelmann BE, Kaprio T, Hansen TF, Glimelius B. Risk of recurrence in patients with colon cancer stage II and III: a systematic review and meta-analysis of recent literature. Acta Oncol. 2015 Jan;54(1):5-16. doi: 10.3109/0284186X.2014.975839. Epub 2014 Nov 28.
Background: PubMed 31070691Reinert T, Henriksen TV, Christensen E, Sharma S, Salari R, Sethi H, Knudsen M, Nordentoft I, Wu HT, Tin AS, Heilskov Rasmussen M, Vang S, Shchegrova S, Frydendahl Boll Johansen A, Srinivasan R, Assaf Z, Balcioglu M, Olson A, Dashner S, Hafez D, Navarro S, Goel S, Rabinowitz M, Billings P, Sigurjonsson S, Dyrskjot L, Swenerton R, Aleshin A, Laurberg S, Husted Madsen A, Kannerup AS, Stribolt K, Palmelund Krag S, Iversen LH, Gotschalck Sunesen K, Lin CJ, Zimmermann BG, Lindbjerg Andersen C. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019 Aug 1;5(8):1124-1131. doi: 10.1001/jamaoncol.2019.0528.
Background: PubMed 30992300Coombes RC, Page K, Salari R, Hastings RK, Armstrong A, Ahmed S, Ali S, Cleator S, Kenny L, Stebbing J, Rutherford M, Sethi H, Boydell A, Swenerton R, Fernandez-Garcia D, Gleason KLT, Goddard K, Guttery DS, Assaf ZJ, Wu HT, Natarajan P, Moore DA, Primrose L, Dashner S, Tin AS, Balcioglu M, Srinivasan R, Shchegrova SV, Olson A, Hafez D, Billings P, Aleshin A, Rehman F, Toghill BJ, Hills A, Louie MC, Lin CJ, Zimmermann BG, Shaw JA. Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence. Clin Cancer Res. 2019 Jul 15;25(14):4255-4263. doi: 10.1158/1078-0432.CCR-18-3663. Epub 2019 Apr 16.
Background: PubMed 32955177Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS; ADAURA Investigators. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Oct 29;383(18):1711-1723. doi: 10.1056/NEJMoa2027071. Epub 2020 Sep 19.
Background: PubMed 33727257Vidal J, Casadevall D, Bellosillo B, Pericay C, Garcia-Carbonero R, Losa F, Layos L, Alonso V, Capdevila J, Gallego J, Vera R, Salud A, Martin-Richard M, Nogue M, Cillan E, Maurel J, Faull I, Raymond V, Fernandez-Martos C, Montagut C. Clinical Impact of Presurgery Circulating Tumor DNA after Total Neoadjuvant Treatment in Locally Advanced Rectal Cancer: A Biomarker Study from the GEMCAD 1402 Trial. Clin Cancer Res. 2021 May 15;27(10):2890-2898. doi: 10.1158/1078-0432.CCR-20-4769. Epub 2021 Mar 16.
BackgroundPowels, T.B. et al., Clinical outcomes in post-operative ctDNA-positive muscle-invasive urothelial carcinoma (MIUC) patients after atezolizumab adjuvant therapy. Annals of Oncology, 2020. 31(suppl_7): S1417-S1424.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kat Kwiatkowski, PhD study director

Strata Oncology

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by Strata Oncology at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and Specificity (time frame: 8 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05082701, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.