Clinical Trial Portfolio

  • Study development
  • Study execution
  • Publication of results
  • End of Study Reports

Ongoing Studies

  • PROMMIS: PRospective Observational Multiple Myeloma Impact Study to measure the impact of MMprofiler on treatment intention in active multiple myeloma patients (NCT02911571) (full execution)
    • All 250 patients enrolled in 9 US sites, currently collecting 5-year outcome data
    • Publications: Biran et al, Br J Haematol, 2025; Biran et al, eJHaem 2021
    • Poster Presentations: ASCO 2019, EHA 2019, ASH 2019, ASH 2023
  • ACT-MBC: A Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer (MBC) (ACT-MBC) (NCT05662345) (full execution)
    • All 60 patients enrolled in 4 US sites, currently collecting outcome data
    • Poster presentations: SABCS 2024, ACTC 2025, SABCS 2025
  • PREDICTII: A Prospective Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast-Conserving Therapy (NCT: NCT03448926) (project management)
    • Enrollment ongoing in 30 US sites
  • CTC-EXPRESS: A Study for CTC Expression and cfDNA/​RNA Assessment in Metastatic Breast Cancer Patients (NCT06833853) (full execution)
    • Opening ~10 US sites

 Completed Studies (development and execution)

  • ASBE: Clinical Utility of a Non endoscopic Device EsoCheck and Biomarker EsoGuard as Alternative to Endoscopy for Screening for Barrett’s Esophagus in At Risk Population (NCT05778851)
    • All 100 subjects enrolled in the US and End of Study report completed
  • PROMIS: PRospective Study Of MammaPrint in Breast Cancer Patients With an Intermediate Recurrence Score (NCT01617954)
    • Enrolment completed (840 patients in 58 US sites in 3,5 years)
    • Publication: Tsai et al, JAMA Oncol 2018
  • NBREaSTII: European Prospective neo-adjuvant REGISTRY trial linking MammaPrint, Subtyping and treatment response
    • Enrolment completed (257 patients in 16 sites in 4 years)
    • Publication: Göker et al, Eur J Cancer, 2022
    • Poster Presentation: Göker et al, EBCC 2018
  • MINTI: Multi-Institutional Neo-adjuvant Therapy MammaPrint Project I (NCT01501487)
    • Enrolment completed (227 patients in 6 sites in 4 years)
    • Publication: Blumencranz et al, Ann Surg Oncol 2023
    • Multiple poster presentations: SABCS 2012, 2013, 2014 and 2016, ASCO 2013 and 2014
  • NBRST: Prospective Neo-adjuvant Breast Cancer REGISTRY Trial (NCT01479101)
    • Enrolment completed (1,200 patients in 35 sites in 2,5 years)
    • Publications (besides many poster presentations):
      • Pellicane et al, Surg Oncol 2022; Whitworth et al, JCO Prec Oncol, 2022; Whitworth et al, Ann Surg Oncol 2022; Groenendijk et al, NPJ Breast Cancer 2019; Whitworth et al, Ann Surg Oncol 2017; Beitsch et al, Ann Surg Oncol 2017; Beitsch et al, Ann Surg Oncol 2016; Baron et al, Ann Sug Oncol 2016; Whitworth et al, Ann Surg Oncol, 2014

Study development

  • CLUE: CLinical Utility Study of EsoGuard® on Samples Collected using EsoCheck as a Triage Test for Endoscopy to identify Barrett’s Esophagus (NCT06030180)
    • Enrollment completed (566 patients in 8 US sites)
    • Publication: Lister et al, Medicina 2024
  • Pilot study to optimize the requisitioning logistics and result report of SLN Profiler
    • Enrolment completed (Mayo Clinic)
  • A phase Ib/II study of leronlimab combined with carboplatin in patients with CCR5+ metastatic triple-negative breast cancer (mTNBC) (NCT03838367) (Data management, data presentation, site close out)
    • Enrolment completed (10 patients in 6 US sites)
    • Poster presentation: Cristofanilli et al, SABCS 2021
  • Leronlimab in Patients With Nonalcoholic Steatohepatitis Phase 2 (NCT04521114) (data management and site close out)
    • Enrolment completed (87 patients in 7 US sites)
  • IMPACt: Measuring the Impact of MammaPrint on Adjuvant and neo-adjuvant treatment decisions in breast Cancer patients: a prospective registry (NCT02670577)
    • Enrolment completed (481 patients in 17 US sites in 1,5 years)
    • Publication: Soliman et al, BMC Cancer 2020
  • WSG-PRIMe: PRospective study to measure the Impact of MammaPrint on adjuvant treatment in hormone receptor-positive HER2-negative breast cancer patients (Prof N. Harbeck) (NCT02911571)
    • Enrolment completed (427 patients in 27 DE, AT and CH sites in 1 year)
    • Würstlein et al, BCRT 2019
  • The Symphony Triple A study: using Symphony as an Adjunct to histopathologic parameters when the doctor is Ambivalent about the Administration and type of adjunctive systemic therapy (NCT02209857)
    • Enrolment completed (660 patients in 33 NL sites in 2 years)
    • Kuijer et al, JCO 2017
  • MammaPrint in Women with Uncertain Benefit of Chemotherapy after Breast Cancer Surgery (PI Dubsky)
    • Enrolment completed (75 patients in 1 Austrian site in 2 years)
    • Exner et al, BJC 2014
  • MINDACT: Microarray in Node Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy (EORTC 10041/BIG 3-04) (NCT00433589)
    • Enrolment completed (6,693 patients in 112 sites)
    • Selected publications (besides many poster presentations and additional publications):
      • Cardoso et al, NEJM 2016
      • Piccart et al, Lancet Oncology 2021

End of Study Report

  • A Multicenter, Single-Arm Study of the Efficacy of EsoGuardTM on Samples Collected Using EsoCheckTM versus Esophagogastroduodenoscopy for the Diagnosis of Barrett’s Esophagus in an At-Risk Screening Population (NCT04293458)