Clinical trial · Observational
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
NCT05082701CI-TRIAL-00077395SentinelterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sentinel MRD test offers no additional or increased benefits to patients compared to current marketed alternatives
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Sensitivity and Specificity
- timeFrame
- 8 years
- description
- 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.
- measure
- ctDNA Response Rate
- timeFrame
- 8 years
- description
- 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.
Secondary outcomes (3)
- measure
- Disease Free Survival (DFS): Duration of time between initiation of treatment and radiographic recurrence (investigator assessment) or death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (8)
- BACKGROUNDSung 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. PMID 33538338
- BACKGROUNDMiller 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. PMID 31184787
- BACKGROUNDBockelman 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. PMID 25430983
- BACKGROUNDReinert 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. PMID 31070691
- BACKGROUNDCoombes 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.